Study Start Up Clinical Research Associate

This is a fully remote position, open to applicants in Kenya.

📋 Description

• Oversee the complete study start-up process for designated sites, from the selection phase to site activation.

• Execute site selection tasks and evaluate site suitability, collaborating directly with Principal Investigators and site teams.

• Independently formulate, organize, and manage submissions to regulatory authorities and Ethics Committees/IRBs/IECs.

• Address regulatory and ethical inquiries and rectify any deficiencies.

• Coordinate the gathering, assessment, and monitoring of essential regulatory documents, including Informed Consent Forms (ICFs), Curriculum Vitae (CVs), Good Clinical Practice (GCP) certificates, financial disclosures, and other site-specific paperwork.

• Maintain study start-up systems, trackers, and documentation within the Trial Master File (TMF) for country/site requirements.

• Collaborate with sites and internal teams to troubleshoot and resolve start-up challenges.

• Assist with vendor, contract, and investigator payment processes as needed.

• Ensure that sites are thoroughly prepared for activation and facilitate a smooth transition to the execution Clinical Research Associate (CRA).

⛳️ Requirements

• Prior experience in clinical trial study start-up, site activation, and regulatory submissions.

• Proven track record of independently managing all aspects of site start-up activities through to site activation.

• Established experience in independently preparing and managing submissions to regulatory authorities and Ethics Committees/IRBs/IECs, including addressing regulatory and ethical inquiries.

• In-depth knowledge of ICH-GCP guidelines, local regulatory standards, essential regulatory documents, and TMF requirements.

• Strong organizational and stakeholder management abilities, capable of independently handling multiple sites, timelines, and competing priorities.

• Candidates must reside in either Nairobi or Kisumu, Kenya.

• Must possess the legal right to work in Kenya.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.