Clinic Research Associate at UNOCASA Limited

Location: Lagos Island, Lagos

Job Description

• They are looking for an organized, flexible clinical research associate to oversee clinical trials.
• The clinical research associate will train site staff and manage Investigational Product (IP) and trial materials.
• The clinical research associate will manage multiple aspects of the subjects' welfare.
• You will conduct regular site visits, generate, and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects.
• You will play a leading role in generating and overseeing documentation and records.
• To be successful in this role, you should be able to recognize logistical problems and initiate appropriate solutions.
• Ideal candidates will be detail-oriented, can multitask, and be able to collaborate with various role players.

Duties and Responsibilities

• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
• Ordering, tracking, and managing IP and trial materials.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Implementing action plans for sites not meeting expectations.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.

Requirements

• M.Sc. Degree in the Life Sciences
• Experience is desirable but not compulsory as training on the job will provided.
• Knowledge of the pharmaceutical industry, terminology, and practices.
• Knowledge of FDA regulations and their practical implementation.
• Strong verbal and written communication skills.
• Proficient computer skills.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to manage and prioritize workload effectively.