Clinical Trial Associate

Job Advertisement Clinical Trial Associate (CTA) & Trial Master File (TMF) Specialist Location: Abuja Department: Clinical Operations Reports To: Director of Clinical Operations Employment Type: Full-Time About the Role We are seeking a highly organized, compliance-driven, and detail-oriented Clinical Trial Associate (CTA) with strong expertise in Trial Master File (TMF) management to support the operational execution and regulatory integrity of our clinical research programs. This position plays a critical role in ensuring that clinical trials are conducted in accordance with ICH-GCP guidelines, applicable regulatory requirements, sponsor SOPs, and protocol specifications, while maintaining inspection-ready documentation at all times. The successful candidate will provide administrative, regulatory, and TMF oversight support across multiple clinical studies (Phase I–IV), working closely with Clinical Trial Managers (CTMs), CRAs, Regulatory Affairs, Data Management, Pharmacovigilance, and external vendors. Position Summary The Clinical Trial Associate & TMF Specialist is responsible for:

• Supporting day-to-day clinical trial operations.
• Ensuring completeness, accuracy, and quality control of the Trial Master File (eTMF and/or paper TMF).
• Facilitating study start-up, maintenance, and close-out activities.
• Maintaining regulatory compliance and audit readiness.
• Coordinating document workflows between sponsors, CROs, and investigational sites.

This role requires strong knowledge of essential document management, regulatory submissions, and clinical documentation standards. Key Responsibilities 1. Clinical Trial Operations Support

• Provide operational support for assigned clinical studies from start-up through close-out.
• Assist with preparation, review, and tracking of study-related documentation (protocols, IBs, ICFs, amendments, safety reports).
• Coordinate Investigator Meetings and study team meetings (agenda preparation, minutes, action tracking).
• Track study milestones and maintain study trackers (site activation, enrollment, monitoring visits).
• Support feasibility assessments and site identification activities.
• Assist in preparation of ethics committee (EC) and regulatory submissions.
• Maintain communication with clinical sites to ensure timely document submission.

2. Trial Master File (TMF) Management • Maintain and oversee the electronic Trial Master File (eTMF) in accordance with:

• ICH E6(R2)/(R3) GCP guidelines
• FDA 21 CFR Part 11
• EMA TMF Reference Model

• Ensure all essential documents are:

• Complete
• Accurate
• Version-controlled
• Filed in the correct TMF zone/artifact

• Perform routine TMF quality control (QC) reviews and periodic completeness checks.
• Reconcile TMF with investigator site files and sponsor files.
• Ensure documentation is inspection-ready at all times.
• Manage document indexing, metadata accuracy, and filing timeliness.
• Support TMF audits and regulatory inspections (FDA, EMA, MHRA, local authorities).
• Generate TMF health metrics and compliance reports.

3. Regulatory & Compliance Oversight

• Track submission and approval of regulatory documents (IRB/EC approvals, renewals, safety letters).
• Maintain up-to-date investigator documentation (CVs, medical licenses, training certificates).
• Ensure compliance with sponsor SOPs and regulatory authority requirements.
• Assist in CAPA documentation and audit follow-up activities.
• Maintain training logs and delegation logs.
• Support vendor oversight documentation where applicable.

4. Study Documentation & Reporting • Maintain study tracking tools including:

• Site activation logs
• Monitoring visit logs
• Enrollment trackers
• Safety reporting trackers

• Support preparation of study status reports.
• Assist with preparation of Clinical Study Reports (CSR) documentation.
• Archive TMF documentation according to retention policies.

Qualifications & Experience Education • Bachelor’s degree in:

• Life Sciences
• Pharmacy
• Nursing
• Public Health
• Biomedical Sciences
• Or related discipline

Advanced certifications in Clinical Research (e.g., ACRP, SOCRA) are an advantage. Experience

• Minimum 2–4 years of experience in clinical research.
• At least 1–2 years of direct TMF management experience (sponsor or CRO environment preferred).
• Experience supporting Phase I–IV interventional clinical trials.
• Experience with eTMF systems (e.g., Veeva Vault, MasterControl, Florence, Wingspan, or similar).
• Prior exposure to regulatory inspections or internal audits is highly desirable.

Technical Knowledge Strong working knowledge of:

• ICH-GCP guidelines
• FDA and/or EMA regulations
• TMF Reference Model structure
• Clinical trial lifecycle
• Document control and quality management systems
• Electronic document management systems (EDMS)
• Microsoft Office Suite (Excel proficiency required)

Core Competencies

• Exceptional attention to detail
• Strong organizational and time-management skills
• Ability to manage multiple studies simultaneously
• Proactive problem-solving mindset
• Strong written and verbal communication skills
• Ability to work independently with minimal supervision
• High level of integrity and confidentiality

Performance Expectations The successful candidate will be evaluated on:

• TMF quality metrics (completeness, timeliness, accuracy)
• Audit readiness status
• Compliance adherence
• On-time regulatory documentation tracking
• Responsiveness to study team needs

What We Offer

• Competitive salary and performance incentives
• Professional development and certification support
• Exposure to global clinical trial programs
• Collaborative and compliance-focused work environment
• Opportunities for career progression within Clinical Operations

How to Apply Interested candidates should submit:

• Updated CV
• Cover letter outlining relevant clinical operations and TMF experience
• References (upon request)

Applications will be reviewed on a rolling basis.