a Specialist Regulatory Affairs Consultancy - UnoCasa Limited
UnoCasa Limited – Our client is a specialist regulatory affairs consultancy providing services in Marketing Authorization Applications, Pharmacovigilance and Clinical Trial Management for clients dealing in NAFDAC regulated products.
They are recruiting an organized, flexible individual to fill the position below:
Job Title: Clinic Research Associate
Location: Lagos Island, Lagos
Employment Type: Full-time
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.
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.
Application Closing Date
How to Apply
Interested and qualified candidates should:
Click here to apply online
To apply for this job please visit forms.gle.