Desired Candidate Profile
Overall responsibility for study management, responsible for monitoring of studies in accordance to protocol/ SOPs/ Guidelines.
RESPONSIBILITIES:
Perform Site Identification and conduct Feasibility Studies.
Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required.
Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities.
Act as a communication Link between Sponsor and the site.
Maintain accurate and timely sponsor/site correspondence and communication.
Attend Investigators Meeting.
Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
Ethics Committee Submission
Help in preparation of Regulatory Binder.
Maintain updated Site Files and collection of the essential documents and project related documents during the site visits and maintain Central Clinical File.
CRF retrieval as per the project instructions.
Coordinate and distribute Clinical Study Material to study sites.
Archival of study documents.
Education :Msc., lifescience,nursing , B.Pharmacy/M.Pharmacy/ PharmD, M.B.B.S, B.D.S, B.H.M.S, B.A.M.S, etc.) and lifescience graduates.
For details
Rani
8148052***
Education:
UG: B.Pharma - Pharmacy, B.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, Optometry, Zoology, BAMS - Any Specialization, Ayurveda
PG: M.Pharma - Pharmacy, MS/M.Sc(Science) - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, Optometry, Veterinary Science, Zoology, MVSC - Veterinary Science
Contact Details:
Keyskills:
molecular biology
biotechnology
biochemistry
zoology
microbiology
biotech
nursing
pharmacy
biomedical
pharmacovigilance
clinical research
clinical data management