Clinical Trial Associate

KEY DUTIES & RESPONSIBILITIES

Study Support & Coordination

• Support the CTM and Clinical Operations team in all aspects of clinical study management from study start-up through close-out.
• Assist in the preparation, review, tracking, and distribution of essential study documents (e.g., protocols, informed consent forms, study manuals, site materials, newsletters).
• Maintain and update clinical trial tracking systems, including study status reports, enrollment metrics, regulatory document trackers, and trial master file (TMF) status.
• Coordinate study meetings such as investigator meetings, study kick-off, and team meetings; prepare meeting agendas, minutes, and follow-up action items.
• Manage collection, quality check, and filing of essential documents in the Trial Master File (electronic or paper-based) to ensure inspection readiness at all times.
• Support vendor oversight activities by maintaining documentation, tracking deliverables, and assisting with vendor performance metrics and invoice review.
• Assist with logistics for shipment of clinical supplies and trial materials to investigational sites.

Communication & Collaboration

· Serve as a primary point of contact for internal cross-functional teams and external partners (e.g., CROs, central labs, and other vendors) for document and data exchange.

· Support study site communication by managing site correspondence, tracking investigator and site staff training documentation, and ensuring timely follow-up on outstanding items.

· Assist in the coordination and review of site-level documents such as regulatory binders, ethics committee submissions, and site activation documentation.

Quality & Compliance

· Support audit and inspection readiness by ensuring TMF completeness and compliance with ICH-GCP, MediLink SOPs, and regulatory requirements.

· Perform quality control checks on study documents and reports to ensure accuracy, consistency, and completeness.

· Assist with reconciliation of data across clinical databases, safety systems, and vendor platforms as needed.

Operational & Administrative Support

· Maintain up-to-date study tracking tools and dashboards for project status, milestones, and key deliverables.

· Support the preparation of study reports, summaries, and internal communications.

· Coordinate processing of invoices and purchase orders, ensuring alignment with work performed.

· Provide administrative support for contracts, confidentiality agreements, and study-level budget tracking.

· Contribute to continuous improvement of Clinical Operations systems, tools, and SOPs.

· Participate in internal training to develop professional and technical skills.

QUALIFICATIONS & REQUIREMENTS

• Bachelor's degree in life sciences, healthcare, or a related field.
• 1–3 years of experience in clinical research or clinical operations (sponsor, CRO, or academic setting).
• Solid understanding of ICH-GCP guidelines, clinical trial processes, and regulatory requirements.
• Strong organizational skills with high attention to detail and accuracy.
• Excellent verbal and written communication skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); familiarity with CTMS or eTMF systems is a plus.
• Ability to manage multiple tasks in a fast-paced, matrixed environment.
• Strong teamwork and interpersonal skills with a proactive and collaborative attitude.
• Ability to work independently under supervision and to problem-solve effectively.
• Willingness to travel occasionally (up to 10%).

Job Type: Full-time

Pay: $80, $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending