Job Description
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.