Medical Monitor

Job Description: Medical Monitors

Qualification: MBBS with any PG or DNB or Diploma.

Experience: 2 - 4 Years’ Experience in Clinical Research Filed.

· Provide protocol and therapeutic area training to study teams (both internal and external).

· Provide response to PI/site/EC queries.

· Prepare medical monitoring plan

· Review of PDs

· CSR/SMP/SAP review

· Review study subject reports (like lab reports, ECG report, cytology, 2D- ECHO, CT, Bone Scan reports, , any assessments etc, as applicable) for eligibility in coordination with Project Manager/Designee.

· SAE management if any, follow up with sites/ investigator for SAE updates and updating sponsor accordingly.

· Review and develop amendments (if required) to Protocol and other study documents such as Safety Monitoring Plan, expedited reporting plans, eligibility review plan.

· Liaison with investigators and sponsor medical monitor for any medical queries.

· Responsible for review of AE and SAE data in the clinical trial for its completeness and accuracy

· Responsible for review of SAE forms received from Sites.

· To communicate various safety related aspects with the stake holders i.e., Study team to site, and various regulatory agencies and Sponsor’s team.

· Responsible for preparation of SAE reporting “Data Elements for Reporting Serious Adverse Events Occurring in A Clinical Trial or Bioavailability or Bioequivalence Study”.

· Responsible for coordination with internal Regulatory and operation team for completion of SAE forms, reconciliation and tracker compilation.

· Responsible for ensuring electronic reporting of SAEs to DCGI, Chairman of Ethics Committees and Head of Institutions within stipulated timelines.

· Responsible for Preparation of individual case narratives.

· Responsible for preparation of the CSR.

· AE, Concomitant Medication, Medical History, Vital signs, Physical examination, I/E listing review.

· Review the blinded study data on regular periodic basis