Clinical Research Associate Lead
Vor 7 Tagen
If you are an experienced CRA Lead who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you
Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.
TRIO is looking for a Clinical Research Associate Lead (internally referred to as Monitoring Resources Coordinator)** **to join our Monitoring Resources team. Reporting to the CRA Manager**,** this position will be home-based in Europe.
**Responsibilities**:
- Supervise assigned Clinical Research Associates (CRAs) to ensure monitoring activities are performed as per requirements (ICH GCPs, local regulatory requirements, TRIO SOPs, trial protocols, timelines and budget), for multiple trials.
- Oversee all trial-related monitoring activities performed by the CRAs.
- Compile monitoring metrics and key performance indicators for the CRAs.
- Communicate regularly on project status to the CRA Manager, Project Management and the Sponsor (if applicable) to ensure project goals are met.
- Proactively identify, escalate or resolve monitoring issues, as appropriate.
- Participate in the selection of internal and external CRAs.
- Coordinate site hand-over process between 2 CRAs as per TRIO or sponsor procedures
- Perform CRA assessment visits, as per TRIO SOP, as required.
- Responsible for ensuring timely site audit report reply (MR part). Responsible for implementation of/ follow-up on corrective actions/preventive actions, when appropriate.
- Ensure timely follow-up on oversight visit findings by the CRAs.
- Prepare and conduct trial-specific calls for Third-Party Organization (TPO) or TRIO CRAs within an assigned country.
- Participate in process improvement initiatives, as required.
**Qualifications**:
- Bachelor's Degree in health fields such as Medical, Nursing, Pharmacy, or Health Science - or its international equivalent.
- A minimum of 3 years of experience in the field as a CRA, oncology knowledge is a major asset.
- Experienced in mentoring and training CRAs in a positive and effective manner
- Excellent knowledge of medical terminology and clinical monitoring process
- Strong ICH-GCPs knowledge
- Ability to prioritize multiple tasks and achieve project timelines
- Must work both independently and in a team environment.
- Excellent verbal and written communication skills and attention to details with an ability to work in a multi-cultural environment
- Read, write and speak fluent English
- Ability to travel up to 30% on average
**What TRIO Can Offer You**:
- Competitive salary
- 30 paid vacation days
- Flexible working hours
- Work from home
- Monthly internet allowance
**Integrity - Teamwork - Passion**
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