Sr. Clinical Research Associate

5 mesi fa

Roma, Italia MSD A tempo pieno

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s 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**:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- 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 internally 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.
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

**Qualifications**

**Education and Minimum Requirements**:

- Bachelor’s or advanced degree in science and/or with relevant work experience in direct site management (monitoring) in bio/pharma/CRO.

**Required Experience and Skills**:

- Fluent in Local Language and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including independent management of site performance and patient recruitment.
- Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
- Experience with conducting site motivational visit designed to boost site enrollment.
- Performs root cause analysis and implements preventative and corrective action.
- Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.

**Behavioral Competency Expectations**:

- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Able to work highly independently across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Positive mindset, growth mindset, capable of working independently and being self-driven.

**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**:R261871

  • Sr. Clinical Research Associate

    5 mesi fa

    Roma, Italia Cmed A tempo pieno

    The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India. The CRO occupies a unique position in the clinical...

  • Clinical Research Associate, Italy

    7 mesi fa

    Roma, Italia EastHORN Clinical Services A tempo pieno

    **Job summary**: As a **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties....

  • Associate Clinical Research Associate

    6 mesi fa

    Roma, Italia MSD A tempo pieno

    The role of **Associate Clinical Research Associate** support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations,...

  • Clinical Research Associate

    4 settimane fa

    Roma, Lazio, Italia Pharmiweb A tempo pieno

    Job Title: Clinical Research Associate - Freelance OpportunityJob Description:We are seeking a non-certified Freelance Clinical Research Associate to monitor two sites in Italy for an ongoing medical device study. Due to this being a Medical Device project, certification is not required.Your Role:Conduct site visits, including initiation, monitoring, and...

  • Sr. Clinical Research Associate

    6 mesi fa

    Roma, Italia MSD A tempo pieno

    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...

  • Associate Clinical Research Associate

    2 mesi fa

    Roma, Italia MSD A tempo pieno

    **Secondary** Language(s) Job Description**: We are looking for an **Ass. Clinical Research Associate** to join our Clinical Research Monitor Team. With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. **Responsibilities...

  • Clinical Research Associate Director

    4 settimane fa

    Roma, Lazio, Italia Msd A tempo pieno

    Job SummaryWe are seeking a highly skilled Associate Director to join our Clinical Research team at MSD. This role will be responsible for managing a team of Clinical Research Associates (CRAs) and ensuring excellent study and site performance.Key ResponsibilitiesManage a team of 6-14 CRAs and ensure strict adherence to local regulations, company SOPs, and...

  • Clinical Research Associate

    3 mesi fa

    Roma, Italia TFS HealthScience A tempo pieno

    **CRA Italy - 0.2/0.4 FTE - FREELANCE** **About this role** TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP)...

  • Lead Clinical Research Associate

    3 settimane fa

    Roma, Italia Ora A tempo pieno

    **POSITION TITLE**: Lead Clinical Research Associate **DEPARTMENT**: Ora Europe **LOCATIONS**:Poland, Spain or Italy **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic...

  • Lead Clinical Research Associate

    1 ora fa

    Roma, Italia Ora A tempo pieno

    **POSITION TITLE**: Lead Clinical Research Associate **DEPARTMENT**: Ora Europe **LOCATIONS**:Remote, Italy **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and...

  • Clinical Research Associate Opportunity in Italy

    4 settimane fa

    Roma, Lazio, Italia Rbw Consulting Llp A tempo pieno

    Rbw Consulting Llp is seeking a Freelance Clinical Research Associate to monitor two sites in Italy for an ongoing medical device study. The ideal candidate will have experience in clinical research, preferably with medical devices, and a strong understanding of GCP and regulatory guidelines. The role involves conducting site visits, ensuring compliance with...

  • Freelance Clinical Research Associate

    1 mese fa

    Roma, Lazio, Italia Rbw Consulting Llp A tempo pieno

    Freelance CRA Opportunity in ItalyRbw Consulting Llp are partnered with a small European CRO seeking a non-certified Freelance Clinical Research Associate to monitor two sites in Rome for an ongoing medical device study.Due to this being a Medical Device project, you do not need to be certifiedYour Role:Conduct site visits, including initiation, monitoring,...

  • Clinical Research Associate

    2 settimane fa

    Roma, Italia MSD A tempo pieno

    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...

  • Clinical Research Associate

    5 mesi fa

    Roma, Italia Meditrial Europe Ltd. A tempo pieno

    Meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access. Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators. Our successful track record supporting medical device and biotechnology companies in all phases of clinical...

  • Lead Clinical Research Associate

    1 settimana fa

    Roma, Italia Ora A tempo pieno

    POSITION TITLE: Lead Clinical Research Associate DEPARTMENT: Ora Europe LOCATIONS: Poland, Spain or Italy Ora Values the Daily Practice of ... Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and...

  • Clinical Research Associate

    5 mesi fa

    Roma, Italia MSD A tempo pieno

    **Job Description**: The role 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, policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Research Associate

    6 mesi fa

    Roma, Italia MSD A tempo pieno

    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...

  • Clinical Research Associate

    4 settimane fa

    Roma, Lazio, Italia Rbw Consulting Llp A tempo pieno

    Rbw Consulting Llp is seeking a Freelance Clinical Research Associate to monitor two sites in Italy for an ongoing medical device study. This is a non-certified opportunity, making it ideal for those new to the field or looking to gain experience in medical device research. Your role will involve conducting site visits, ensuring compliance with study...

  • Clinical Research Associate Ii

    6 mesi fa

    Roma, Italia ABBVIE A tempo pieno

    **Key responsibilities**: - Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring...

  • Associate Clinical Research Associate

    6 mesi fa

    Roma, Italia MSD A tempo pieno

    **Job Description**: With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site...