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We are recruiting to fill the position below:
Job Title: Experienced Clinical Research Associate (CRA II / Senior CRA)
Location: Jabi, Abuja
Employment Type: Full-time
About the Role
We are seeking a highly skilled and self-driven Experienced Clinical Research Associate (CRA II / Senior CRA) with 4–7 years of independent site monitoring experience to join our dynamic Clinical Operations team.
This role is ideal for a CRA who is confident in managing complex clinical trial sites, ensuring GCP compliance, driving data quality, and serving as a trusted partner to investigators and sponsor teams.
As an essential member of the project delivery function, you will independently oversee end-toend site management activities across Phase I–IV studies and play a critical role in ensuring patient safety, operational excellence, and high-quality trial execution
Key Responsibilities
Independent Site Monitoring & Management:
Conduct and document all types of monitoring visits.
Perform comprehensive source data verification (SDV), source data review (SDR), protocol compliance checks, safety data review, and regulatory oversight.
Utilize a risk-based monitoring approach to identify trends, assess site performance, and proactively mitigate operational challenges.
Provide continuous operational support to sites, ensuring timely data entry, query resolution, and audit readiness.
Protocol & GCP Compliance:
Ensure investigative sites adhere strictly to ICH-GCP, local regulations, study SOPs, and protocol-specific requirements.
Identify, document, and escalate protocol deviations, safety non-compliance, and data risks.
Support sites in implementing corrective and preventive action plans (CAPAs).
Safety Oversight:
Verify accuracy, completeness, and timeliness of AE/SAE documentation. • Ensure sites follow appropriate safety reporting pathways and timelines.
Investigational Product (IP) Accountability:
Conduct detailed IP accountability checks, including temperature excursion assessments, dispensing logs, and IRT/IVRS reconciliation.
Support sites in proper storage, handling, and documentation of all investigational supplies.
Study Start-Up & Close-Out:
Conduct qualification assessments, feasibility engagements, and site readiness reviews.
Train site personnel on protocol updates, study systems, operational workflows, and safety reporting requirements.
Lead the site through regulatory completion activities, archiving, and closure documentation.
Documentation & Reporting:
Prepare high-quality monitoring visit reports, follow-up letters, and site correspondence within required timelines. • Maintain accurate, audit-ready documentation in eTMF or sponsor-designated systems.
Ensure that all site activities are appropriately tracked, communicated, and escalated where necessary.
Cross-Functional Collaboration:
Collaborate with Project Managers, Data Managers, Safety teams, Start-Up Specialists, Medical Monitors, and other CRAs.
Contribute to study-level risk assessments, monitoring strategies, and operational readiness reviews.
Participate in investigator meetings, site training sessions, and process improvement initiatives.
Leadership, Coaching & Oversight:
Mentor junior CRAs and assist in the evaluation of CRA performance where required. Conduct co-monitoring visits, provide feedback, and help new CRAs transition to independent monitoring.
Represent the CRA team during internal meetings and sponsor interactions.
Requirements
Education & Experience:
Bachelor’s or Master’s Degree in Life Science, Pharmacy, Nursing, or related field.
4 – 7 years of direct, hands-on monitoring experience in Phase I–IV clinical trials.
Demonstrated success in managing high-enrolling, difficult, or rescue sites.
Experience in at least one major therapeutic area (Oncology preferred; others include Infectious Diseases, Vaccines, CNS, Cardiovascular, Endocrinology).
Technical Skills:
Strong proficiency with EDC systems (Veeva Vault, Medidata Rave, Oracle Inform, Viedoc, REDCap).
Solid understanding of eTMF platforms and sponsor-specific documentation systems.
Strong knowledge of ICH-GCP, regulatory guidelines, trial master file (TMF) requirements, and quality expectations.
Behavioral Competencies:
Exceptional communication and relationship-building skills.
Strong analytical, problem-solving, and critical-thinking ability.
High attention to detail paired with excellent time management.
Comfortable working independently and making informed decisions under pressure.
Committed to continuous learning and operational excellence.
What We Offer
Competitive salary and performance-based rewards
Comprehensive medical and wellness benefits
Flexible or hybrid working arrangements.
Application Closing Date
31st December, 2025.
How to Apply
Interested and qualified candidates should send their CV and portfolio to: avsabujacareer@gmail.com using the Job Title as the subject of the email.