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Pharmacovigilance Associate/ Clinical Research Analyst Wanted

Keywords / Skills : molecular biology, biotechnology, biochemistry, zoology, microbiology, biotech, nursing, pharmacy, biomedical, pharmacovigilance, clinical research, clinical data management

Posted: 2018-12-04

Job Description
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 : B.Pharmacy/M.Pharmacy/ PharmD, M.B.B.S, B.D.S, B.H.M.S, B.A.M.S, etc.)

Job description:

Overall responsibility for study management, responsible for monitoring of studies in accordance to protocol/ SOPs/ Guidelines.

Clinical RESEARCH(study set up, conduct and close out phases).

For details

7540052460 Desired Candidate Profile
Please refer to the Job description above

About Company

Resolve GROUP OF COMPANIES Resolve is a leading global research organization providing comprehensive, integrated drug development, laboratory management services. Our clients and partners include pharmaceutical, biotechnology, medical device, and academic and government organizations. Resolve applies innovative research, therapeutic expertise and a firm commitment to Pharma companies and time curve of drug development and optimize value in delivering life-changing therapies, drugs to improve health.
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