Responsible for coordinating and performing (if applicable) the collection, distribution and storage/ archival of data/ study material/ study supply generated (for assigned studies) during clinical research trials.
Responsible to ensure that the assigned trials stay on track with applicable regulations, GCP, Protocol and Tech Observer/ Sponsor SOP’s.
Maintain databases of patient information; collect information for grant proposals and write correspondence.
Maintain Investigator database and search new potential Investigators for upcoming trials.
Enter data from forms and documents into databases as required for assigned studies.
Provide assistance to operational team by organizing files, projects, data and keeping it up to date for assigned studies.
Maintain Trial Master File (TMF) in coordination with APM/PM for assigned studies.
Assist CRA for the maintenance of the Site Master File ( SMF)
Assist with routine in-house data verification and quality control, ensuring data integrity and consistency with prescribed study protocol for assigned studies.
Use Standard Operating Procedures (SOPs) concepts, practices in a time sensitive manner.
Assist CRA in investigator meeting preparation, liaison, presentations, and follow up for assigned studies.
Assist CRA in tracking the Investigator site payment and liaise with sites for follow up on open issues, recruitment status update, required documents for TMF & resolution of open queries in CRF. Ensure timely submission of protocol / consent documents for EC/IRB approval. Including follow up for the approval status from site personnel for assigned studies
Communicate progress of study and relevant information to Project Manager/ CRA and other project team members as requested for assigned studies.
Assist CRA in archiving of study files on completion of a clinical trial.
May coordinate with vendors involved in a clinical trial as requested for assigned studies.
Other responsibilities as delegated by the Project Manager (PM)/ Assistant Project Manager (APM).
Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.
Senior Clinical Trial Associate • Mangalore, IN
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