Clinical Trial Associate
Proclinical is currently recruiting for a Clinical Trial Associate with a leading biotechnology company located in Stamford, CT. As Clinical Trial Associate, you will provide support to clinical trial manager(s) for all phases of study conduct (feasibility, start-up, maintenance, and close-out) of clinical trials.
- Assist with meeting planning for clinical trial activities including vendor, investigator, consultants, safety boards, data monitoring committees, and other external clients.
- Assist in execution of Clinical Trial Communication plan, including coordination of site teleconferences, blast communication, newsletters.
- Attend study team meetings and prepare and distribute study team agendas and minutes as needed.
- Assist in maintaining study status updates on a weekly basis (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.).
- Assist managers in tracking contracts, invoices, and payments with SMOs, CROs, consultants, vendors and investigators, as appropriate.
- Provide appropriate regulatory documents to Regulatory Affairs team for submission to FDA and other ex-US competent authorities, as needed.
- Provide regulatory agency inspection support by formatting, proofreading documents and contributing to the review of the Trial Master File.
- Ensure quality and standardization of documentation that support the clinical program team to ensure document quality requirements and timelines are met.
- Assist in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents.
- Perform periodic regulatory document QC and reconciliation activities, to ensure inspection readiness and regulatory compliance.
- Ensure complete Central Files are in place at time of study closure.
- Ensure TMF completeness and accuracy based on Standard Operating Procedures and regulatory requirements.
- Assist clinical trial manager(s) with preparation, handling and distribution of Clinical trial supplies and maintenance of tracking information.
- Assist with data review and manage operational clinical trial data to ensure quality and completeness per data quality standards.
- Provides oversight of Clinical CRO Investigator background checks.
- Track in house training of CRO's SOPs.
- Preparation and organization of Power Point presentations.
- Preparation and maintenance of investigator information tracker for clinical trial operations.
- Assist with clinical trial protocol and clinical study report (CSR) review, and support for documentation requirements for CSR appendices.
- Provide support for external publications/presentations.
- Assist with tracking of site approvals and denials of study participations.
- Mentor as appropriate to other CTAs within the group.
Skills and Requirements:
- Bachelor's Degree.
- Minimum 3-5 years of experience in related area.
- Excellent planning, coordination, and time management skills to meet deadlines required.
- Demonstrated organization skills and attention to detail.
- Proficient computer skills (e.g. Microsoft Word, Excel, and PowerPoint) required.
- Ability to work independently and with a team.
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.