Clinical Research Associate at Clinique Research

About the job

• Clinique Research is seeking a skilled “Clinical Research Associate” to manage all aspects of assigned research studies.
• You are accountable for achieving successful execution of assigned studies in accordance with Good Clinical Practices (GCP), applicable regional regulatory requirements, and the company’s policy.
• You are required to be organized, analytical, and thorough in owning, coordinating, and managing all aspects of clinical studies from inception to completion within the set timeframe, budget, and scope.

Responsibilities include:

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with scope of work, monitoring plan, standard operating procedures (SOP), GCP, and other regulatory requirements
• Support the development and/or review study administration documents, including study-specific informed consent documents, study manuals and plans, trial master files, case report forms etc.
• Participate in the investigator recruitment process and assess the operational feasibility of projects/studies and prepare execution and risk mitigation plans. Participate in meetings with investigational sites, key opinion leaders, and consultants as needed.
• Train site staff on the protocol, study methodology and electronic systems, as applicable.
• Serve as the primary liaison between Clinique Research and assigned sites. Coordinates all correspondence and respond promptly and appropriately to study questions and issues raised by investigational sites.
• Develop study trackers and logs for managing study conduct, as well as a reporting template for study updates.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, screening and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure the accuracy and completeness of clinical data through remote review of electronic data and documents and on-site source documentation verification.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation
• Participate in vendor selection, negotiation, contract development, and management.
• Oversee the performance of vendors to ensure compliance with study protocol/project plan and in accordance with scope of work while adhering to project timelines.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team.
• Perform other duties as assigned.

Knowledge and Skills

• Must have a thorough knowledge of research concepts, practices, NAFDAC regulations, and ICH Guidelines. Knowledge of FDA and EU regulations as they apply to clinical research is a plus.
• Excellent client-facing and internal communication skills.
• Excellent written and verbal communication skills.
• Solid organizational skills including attention to detail and multitasking skills.
• Strong working knowledge of Microsoft Office, particularly Excel, PowerPoint, and Project.

Education & Certifications

• Bachelor’s Degree (preferably in the health or life sciences discipline).
• MSc, MBA, MPH, PhD, MD, or other relevant Graduate or Postgraduate degree is a plus.
• CRA certification (ACRP or equivalent) is a plus.
• Prior clinical research training certification is a plus.

Experience

• Two or more years of clinical operations experience in the Pharmaceutical, Biotechnology, Medical Device, or CRO industry is required.
• Thorough knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
• Excellent organizational and problem-solving skills
• Excellent written and verbal communication skills
• Success at managing international studies a plus

Other

• Authorization to work in Nigeria
• Valid international travel documentation
• Occasional travel (<40%) is required