Clinical Research Associate

Thepharmadaily LLP

Posted: 5 months ago
Openings: 10
Applicants: 0

Job Description

As a Clinical Trial Coordinator, you will play a vital role in managing clinical trials from protocol development to site closure. Your will include creating and writing trial protocols, training site staff, and ensuring compliance with regulatory guidelines.

Key :

Develop and present trial protocols to the steering committee.
Identify, evaluate, and establish trial sites, and manage site closure upon trial completion.
Train site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
Liaise with the ethics committee to ensure the rights, safety, and well-being of trial subjects.
Order, track, and manage investigational products (IP) and trial materials.
Oversee and document IP dispensing inventory and conduct reconciliation.
Protect subjects confidentiality, update their information, and verify that IP has been dispensed and administered per protocol.
Conduct regular site visits, coordinate project meetings, and write visit reports.
Implement action plans for sites that are not meeting performance expectations.
Liaise with regulatory authorities to ensure compliance.
Ensure adherence to SOPs, local regulations, ICH, and GCP guidelines.
Perform other tasks and as needed.