Clinical Research Interns

Job Description – Clinical Research Coordinator Intern
Company: Biofact Research Pvt. Ltd.
Site: Vishwaraj Hospital, Loni Kalbhor, Pune
Position: Clinical Research Coordinator Intern
Key Responsibilities:
Assist the Clinical Research Coordinator and Principal Investigator in the conduct of clinical trials.
Maintain essential study documents and Trial Master File (TMF)/Investigator Site File (ISF).
Assist with patient screening, recruitment, enrollment, and follow-up activities.
Support the informed consent process as per the approved protocol and ICF.
Maintain accurate source documents, study logs, and clinical trial records.
Assist with EDC data entry and query resolution.
Coordinate with the PI, sponsor/CRO, laboratory, pharmacy, and other study team members.
Assist in preparation for SIV, IMV/monitoring visits, audits, and EC submissions.
Maintain study-specific logs, including screening, enrollment, delegation, training, IP accountability, and temperature logs.
Follow the study protocol, ICH-GCP guidelines, SOPs, and applicable regulatory requirements.
Assist in collection, processing, storage, and shipment of clinical trial samples as per protocol requirements.
Maintain confidentiality and ensure patient safety and data integrity.
Eligibility:
B.Pharm / M.Pharm / B.Sc. / Life Sciences / Pharmacy or relevant qualification.
Basic knowledge of clinical research and ICH-GCP.
Good communication and documentation skills.
Willingness to learn clinical trial operations.
Internship Certificate:
An official internship completion letter/certificate will be provided upon successful completion of the internship.