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Clinical Research Associate
3 months ago
Qualification:
Bachelor’s Degree OR Masters Degree (Science/Life Science)
Experience Required:
Minimum 2 + years of experience
Roles and Responsibilities:Authorizing Clinical trial protocols and presenting these to the steering committee.Identifying, evaluating, and establishing trial sites, and closing sites down on completion of 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 that IP has 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.Identifying/selecting an investigator or conducting the trial.Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedures for the clinical trials as per applicable regulatory requirements.Verify that the investigator and investigators team are adequately trained and comply with the protocol and IRB/IEC operations, and comply as per GCP, SOP, and applicable regulatory requirements.Protocol Deviation/Violations, Informed consent procedures, source data verification, and monitoring the trial throughout a specified duration involving monitoring visits to the trial sites.Writing visit reports, filing and collecting trial documentation and reports.Quality AssuranceLiaising with regulatory authorities.Ensuring compliance with SOPs local regulations, and ICH and GCP guidelines.Responsible for management of documents like maintenance of SOPs, preparation and distribution of controlled and uncontrolled copies of SOPs & and study documents.Responsible for maintenance of training records of Clinical Trials department members.Responsible for assisting Head QA in planning, conducting, and reporting of System Audits of the Clinical Trials department and other applicable departments to ensure compliance with SOPs, Protocol, ICH GCP, quality system, and applicable regulatory requirements.Responsible for archival of QA documents including project-related documents, obsolete versions of SOPs, training records of ex-employees, calibration records, etc.Perform other duties as assigned by the Head of the department / Management.
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Location
- Mumbai
