Clinic Associate - 2 Years Experience

Responsibilities:
-Creating and writing trial protocols, and presenting these to the steering committee.
-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:
-Bachelor's degree in biological science or a related field.
-2+ years of experience as a clinical associate.
-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.
-Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
-Valid driver's license, proficient driving skills, own reliable transport, and up-to-date car insurance.