Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow.
Job Title : Clinical Research Associate
Experience : 1 – 5 years
Location : Mumbai
Job Description:
- Facilitate and coordinate with investigator and site for EC submission and approval.
- Conduct site feasibility and qualification visits.
- Get trained on trial and documents.
- Prepare for kickoff
- meetings to train vendor representatives involved if outsourced
- activity for monitoring.
- Coordinate with investigator and sites for IM and assist PM in planning for IM
- Conduct SIVs, write SIV reports, and dispatch to sites
- Resolve queries and problems at sites and with vendors.
- Monitor sites, write monitoring visit reports and send timely monitoring followup
- letters to sites.
- Obtain updated weekly trackers from sites
- Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
- Coordinate with data management team and investigator/site team for timely DCF resolution.
- Ensure CSR submission by investigator to EC, to regulatory authority (as applicable)
- Conduct site closeouts
- and write closeout
- reports and dispatch to sites.
- Arrange trial document archival at sites, inhouse,
- and/or by third party as applicable.
- Onsite Monitoring: more than 30
Desired Profile:
- UG -B.Pharma – Pharmacy, B.Sc – Any Specialization
