Clinical Research Associate
Clinical Research Associate
Spento papers India LLP
Mumbai, Maharashtra, India
See who Spento papers India LLP has hired for this role
To be successful in this role, you should be able to recognize logistical problems and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask, and be able to collaborate with various role players.
Clinical Research Associate 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.
This job is provided by Shine.com
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Seniority level
Entry level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
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