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.

Job Responsibilities:

• 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 n.aganon@proclinical.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.

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