Clinical Trial Assistant Openings for Pharma / Health Science / Life Sciences
Clinical Trial Assistant Openings for Pharma / Health Science / Life Sciences
Company Name : Tech observer
Location : NOIDA
Job Requirements
Minimum Qualification: Graduation in Pharma / Health Science / Life Sciences
Minimum Experience: At least 1 year experience Clinical Research
Key Responsibilities
- 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. databases
- Enter data from forms and documents into 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).
To know more please shoot me an email at [email protected] with your queries and if you’re interested, kindly share me resume through email along with a good time frame to discuss the opportunity further in detail.
