9 Posti di lavoro per Clinical research associate in Roma

Clinical Research Associate

Roma, Lazio Veeda Lifesciences

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Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Italy for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

Job overview :

The CRA is responsible for ensuring the conduct of clinical trials at selected investigational sites complies with approved protocols, ICH GCP guidelines, SOPs, and applicable laws and regulations. The CRA acts as the primary communication link between the Sponsor, Investigators, and study personnel, aiming to build successful working relationships. Ensuring subjects' rights are respected and that all clinical data are accurate, complete, and source-verified is paramount.

Main responsibilities :
  1. Ensure compliance with the company's Quality and Information Security Management Systems, ICH GCP, local and international legislation, including data protection laws.
  2. Report deviations from protocols or regulations to the Line Manager according to SOPs.
  3. Conduct site feasibility and selection visits, evaluating resources and facilities.
  4. Collaborate with Regulatory Affairs and Clinical Operations for submissions, contracts, and study approvals.
  5. Explain study purposes and procedures to Investigators, providing training and support.
  6. Maintain and update clinical trial files, ensuring proper documentation.
  7. Manage study medication supply, verifying drug accountability and handling shipments and storage.
  8. Monitor trial conduct at sites, including verifying data accuracy, informed consent, and compliance with protocols and regulations.
  9. Ensure proper reporting of safety information and adverse events.
  10. Prepare monitoring reports and communicate findings to Investigators and the CRA Manager.
  11. Assist in audits and inspections, facilitating corrective actions.
  12. Support site feasibility, patient recruitment, and study closure procedures.
  13. Participate in planning, SOP development, and team meetings.
  14. Provide coaching and mentorship to less experienced CRAs.
Job Requirements :
  • Bachelor’s and/or Master’s degree in Health Sciences or related field.
  • Certified CRA.
  • 6-12 months of CRA experience.
  • Fluent in English and Italian, both spoken and written.
  • Attendance of ICH GCP training (preferred).
  • Good computer and communication skills.
  • Strong organizational skills and ability to work independently and in teams.
  • Effective communication skills, diplomatic and assertive.
  • Ability to handle stressful situations and manage multiple issues.
  • Compliance with SOPs, regulations, and ethical principles.
  • Willingness to travel frequently, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in clinical research. We offer a competitive remuneration package.

We prioritize data protection and respect your privacy. For more information, please visit our Privacy Notice to Candidates.

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Clinical Research Associate

Roma, Lazio JR Italy

Inserito 18 giorni fa

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Descrizione Del Lavoro

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CliniRx CRA Positions - Global Study Support Q1 2025

CliniRx has a number of CRA positions available to support a global study in Q1 2025.

We are expanding rapidly and offer multiple permanent opportunities to join us on a global study. Ideally, candidates will have a CRO background with experience across multiple therapeutic areas.

As a global contract research organization (CRO), we provide a diverse range of clinical development and resource solutions, including full-service CRO and functional service provider (FSP) models. We support clinical outsourcing needs for emerging biotech and pharmaceutical companies, especially small to mid-size enterprises facing unique challenges. Our presence includes key markets such as the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.

Primary Purpose

We are seeking skilled CRAs to ensure the timely and quality delivery of site monitoring activities in accordance with our Site Monitoring Plan (SMP).

Key Responsibilities
  1. Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality standards and timelines.
  2. Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
  3. Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
  4. Continuous Skill Development: Regularly enhance technical and soft skills to improve performance and project outcomes.
Work Relations
  • Report to the Manager of Clinical Operations regarding project, functional, and administrative matters.
  • Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.
Value Added

Your adherence to quality standards and timelines is crucial for the efficient delivery and success of our projects.

Key Success Factors
  • Timely and high-quality execution of site monitoring activities.
  • Prompt report generation and submission to stakeholders.
  • Education: Bachelor’s or Master’s degree in a scientific discipline.
  • Experience: 1-4 years in site monitoring within clinical research.
  • Skills: Strong understanding of ICH GCP and clinical trial regulations; excellent communication skills; ability to multitask under demanding timelines.
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Clinical Research Associate

46025 Roma, Lazio Planet Pharma

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Location:
Rome or Bologna, Italy

Employment Type:
Full-time

Travel:
Approximately 5–8 site visits per month

Position Summary

We are seeking an experienced and motivated Clinical Research Associate (CRA) with a strong background in oncology clinical trials to join our dynamic team. The CRA will be responsible for the full lifecycle of clinical site management, including site setup, monitoring, and close-out activities. This role involves working on complex studies and challenging sites, ensuring compliance with protocols, SOPs, ICH-GCP, and applicable regulatory requirements.

Key Responsibilities

  • Participate in site identification and feasibility assessments
  • Manage all aspects of study site operations , including training site staff, ensuring supply of study materials and IMP, and providing recruitment updates
  • Collect, assess, and reconcile essential documents and maintain the Investigator Site File
  • Conduct pre-study, initiation, monitoring, and close-out visits in accordance with SOPs and monitoring plans
  • Assess IP accountability, dispensation, and compliance
  • Prepare and submit accurate and timely monitoring visit reports
  • Collaborate with Clinical Trial Managers (CTMs), Project Managers, and Sponsors
  • Attend internal and external project meetings to provide site updates
  • Utilize clinical systems such as CTMS, eTMF, IVRS/IWRS, and EDC
  • Support and facilitate site audits and resolve audit findings
  • Mentor junior CRAs and lead observational visits
  • Identify and escalate quality or data integrity issues
  • Contribute to process improvement initiatives , including SOP and work instruction updates

Qualifications

Essential

  • Bachelor’s degree in Nursing, Life Sciences, or Medical Sciences (or equivalent experience)
  • Proven experience as a CRA with a strong understanding of clinical research fundamentals
  • Experience in oncology trials
  • Proficiency in CTMS, eTMF, IXRS, and EDC systems
  • Excellent communication and presentation skills
  • Fluent in English and Italian
  • In-depth knowledge of ICH-GCP and regional clinical research regulations
  • Ability to work independently and manage complex sites
  • Strong problem-solving and decision-making skills

Desirable

  • Advanced degree (e.G., Master’s, MD, PhD )
  • Prior experience in a CRO environment
  • Experience in clinical trial planning and metrics management
  • Demonstrated mentoring and leadership capabilities

Why Join Us?

  • Work on cutting-edge oncology trials
  • Be part of a collaborative and supportive team
  • Opportunities for career development and mentoring
  • Competitive compensation and flexible work arrangements

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Clinical Research Associate

Roma, Lazio MSD

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The role of Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

**Responsibilities include, but are not limited to**:
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Supports and/or leads audit/inspection activities as needed.

**Experience Requirements**:
Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.

**Educational Requirements**:
B.A./B.S. with strong emphasis in science and/or biology.

**CORE Competency Expectations**:
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices.
Proven Skills in Site Management including management of site performance and patient recruitment.
Demonstrated high level of monitoring skill with independent professional judgment.
Ability to understand and analyse data/metrics and act appropriately.
Capable of managing complex issues, works in a solution-oriented manner.
Performs root cause analysis and implements preventative and corrective.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Search Firm Representatives Please Read Carefully

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**: R
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Clinical Research Associate- Fsp

Roma, Lazio Labcorp

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**Job Overview**:
Labcorp FSP are looking to hire a CRA I **based preferably in MILAN OR ROME but we can consider also other well connected locations**

In this position you will be fully dedicated to our sponsor and will be home based.

At Labcorp, you can redefine what is possible and discover your extraordinary potential within our **Functional Service Provider** team (FSP).

As a Labcorp employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Labcorp has an FSP opportunity to match your area of expertise.

Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Labcorp studies.

With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

**Responsibilities** **include**:

- All details of site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and collaboration with Labcorp legal department with statements of agreements
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Labcorp or client data management systems
**Education/Qualifications**:

- University degree in life sciences (preferrably in pharmacy), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- **
CRA certification** and some clinical trials experience
**Experience**:

- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Ability to resolve project-related problems and prioritize workload for self and team

REMOTE - HOME BASED
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Clinical Research Associate II - Oncology

Roma, Lazio AbbVie

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Overview

Clinical Research Associate II - Oncology at AbbVie. Join to apply for the Clinical Research Associate II - Oncology role at AbbVie.

Responsibilities
  • Acts as the primary Sponsor point of contact for the investigative site. Demonstrates a high level of competency or experience in providing contextual information on the clinical trials. Connects stakeholders to the investigative sites and strengthens AbbVie’s positioning.
  • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
  • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance with the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and quality standards, ensuring safety and protection of study subjects.
  • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned studies. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
  • Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient’s disease journey.
  • Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
  • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
  • May participate in global/local task forces and initiatives. Responsible for activities assigned by manager.
  • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
  • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  • Ensures audit and regulatory inspection readiness at all assigned clinical sites.
  • Manages investigator payments as per executed contract obligations, as applicable
Qualifications
  • Bachelor’s degree or equivalent degree; health-related fields preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
  • Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
  • Minimum of 1 year of clinically related experience, of which at least 6 months are required in clinical research monitoring of investigational drug or device trials. Familiar with risk-based monitoring approach, onsite and offsite monitoring.
  • Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
  • Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
  • Demonstrates strong cross-functional collaboration skills among internal and external stakeholders.
  • Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
  • Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
  • Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
  • Ability to use functional expertise, leverage critical thinking skills and apply good judgment to address clinical site issues.
  • Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
  • Self-motivated individuals focused on delivering timely and quality outcomes in a fast-paced environment.
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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Clinical Research Associate II - Oncology

Roma, Lazio AbbVie Inc

Inserito 3 giorni fa

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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.

Key Responsibilities
  • Acts as the primary Sponsor point of contact for the investigative site. Demonstrating a high level of competency or experience in providing contextual information on the clinical trials. Connects stakeholders to the investigative sites and strengthens AbbVie’s positioning.
  • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
  • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance with the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
  • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned studies.Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
  • Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient's disease journey.
  • Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
  • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
  • May participate in global/local task forces and initiatives. Responsible for activities assigned by manager.
  • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
  • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  • Ensures audit and regulatory inspection readiness at all assigned clinical sites.
  • Manages investigator payments as per executed contract obligations, as applicable
Qualifications
  • Bachelor's degree or equivalent degree; health-related fields preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
  • Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
  • Minimum of 1 year of clinically related experience, of which at least 6 months are required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
  • Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
  • Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
  • Demonstrates strong cross-functional collaboration skills among internal and external stakeholders.
  • Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
  • Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
  • Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
  • Ability to use functional expertise, leverage critical thinking skills and apply good judgment to address clinical site issues.
  • Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
  • Self-motivated individuals focused on delivering timely and quality outcomes in a fast-paced environment.
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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Clinical Research Associate II - Oncology

Roma, Lazio AbbVie

Inserito 4 giorni fa

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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Key Responsibilities:
+ Acts as the primary Sponsor point of contact for the investigative site. Demonstrating a high level of competency or experience in providing contextual information on the clinical trials. Connects stakeholders to the investigative sites and strengthens AbbVie's positioning.
+ Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
+ Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance with the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
+ Advanced understanding of site engagement and ability to customize site engagement strategy for assigned studies. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
+ Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient's disease journey.
+ Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance."
+ Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
+ May participate in global/local task forces and initiatives. Responsible for activities assigned by manager.
+ Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
+ Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
+ Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
+ Ensures audit and regulatory inspection readiness at all assigned clinical sites.
+ Manages investigator payments as per executed contract obligations, as applicable
Qualifications
Requirements:
+ Bachelor's degree or equivalent degree; health-related fields preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
+ Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
+ Minimum of 1 year of clinically related experience, of which at least 6 months are required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
+ Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
+ Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
+ Demonstrates strong cross-functional collaboration skills among internal and external stakeholders.
+ Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
+ Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
+ Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
+ Ability to use functional expertise, leverage critical thinking skills and apply good judgment to address clinical site issues.
+ Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
+ Self-motivated individuals focused on delivering timely and quality outcomes in a fast-paced environment.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Informazioni sulle ultime novità Clinical research associate Posti di lavoro;/Posti Vacanti nella Roma !

Clinical Research Associate - W/m/d

Roma, Lazio EPM Scientific

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Descrizione Del Lavoro

Cerchiamo un CRA Junior, in Italia, motivato per supportare studi clinici garantendo qualità e conformità.

Requisiti:

- 1-3 anni di esperienza come CRA (ruolo Junior).
- Esperienza in visite pre-site.
- Ottima conoscenza delle lingue inglese e italiano.
- Capacità di lavorare in modo indipendente e in team.
- Eccellenti capacità comunicative e organizzative.

Cosa Offriamo:

- Ruolo remoto a tempo pieno (1.0 FTE).
- Contratto di 12 mesi con possibilità di rinnovo.
- Opportunità di crescita professionale in un ambiente stimolante e innovativo.
- Pacchetto retributivo competitivo e benefici in linea con gli standard del settore.

Responsabilità Principali:

- Condurre visite di pre-selezione (PSV) per valutare l'idoneità dei siti.
- Monitorare i siti clinici per garantire la conformità ai protocolli di studio e alle

normative.
- Collaborare con i team di progetto per assicurare il corretto svolgimento degli studi.
- Redigere e mantenere la documentazione di studio accurata e completa.
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Associate Clinical Research Manager (Acrm) &

Roma, Lazio MSD

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**Job Description**:
We aspire to be the premier research-intensive biopharmaceutical company in the world. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships. Today, we continue to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases, such as HIV and Ebola, and emerging animal diseases.

Our purpose is to save and improve lives for generations. Our strategy is simple: We follow the science. The path to discovery is often unclear, but we are tireless in seeking solutions for some of the world’s most difficult health challenges.

The roles of **aCRM** (Associate Clinical Research Manager) and **CRM** (Clinical Research Manager) are primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

**Responsibilities include, but are not limited to**:

- Main Point of Contact (POC) for assigned protocols and the link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required.
- Leads local study teams to high performance: trains in the protocol of other local roles, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
- Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
- Identifies and shares best practices across clinical trials, countries, and clusters.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Country POC for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent our company with investigators.
- Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
- Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH, and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, and Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.

**Qualifications**

**Education and Minimum Requirements**:
Bachelor’s or advanced degree in science with some years of relevant work experience in clinical research.

**Required Experience and Skills**:

- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
- Requires a strong understanding of the local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Experience functioning as a key link between Country Operations and Clinical Trial Teams
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
- Proficiency in written and spoken English and Italian. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking.
- Ability to work efficiently in a remote and virtual environment.
- Understand cultural diversity.
- The posi
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