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 nancy@tech-observer.com 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.