Clinical Research Associate
Job Description
Key Responsibilities
1. Clinical trial Execution / monitoring: Preparation / review and submission of Clinical study documents to regulatory, Clinical trial execution and monitoring for differentiated products and product intended for India regulatory, Quality checking of the documents during monitoring, cross-verifying the data recorded in Case Report Form with the source document, reviewing informed consent form, reviewing patient eligibility. Quality oversight and Remote Monitoring of patient based bio-equivalence / clinical-endpoint studies. In case of any discrepancy reporting to Medical Monitor, Team leader In Order to ensure trial is conducted as per protocol and ICH-GCP guidelines.
2. Identification of new investigators: Identifying new investigator for the trial from different database, contacts with sites. Doing proper feasibility to the site. In Oder to ensure the site recruits the patient properly and conduct studies as per the guidelines and protocol.
3. Budget negotiation: Negotiating the trial budget with the sites to maintain uniformity within sites In order to ensure smooth budget negotiation process.
1. Clinical trial Execution / monitoring: Preparation / review and submission of Clinical study documents to regulatory, Clinical trial execution and monitoring for differentiated products and product intended for India regulatory, Quality checking of the documents during monitoring, cross-verifying the data recorded in Case Report Form with the source document, reviewing informed consent form, reviewing patient eligibility. Quality oversight and Remote Monitoring of patient based bio-equivalence / clinical-endpoint studies. In case of any discrepancy reporting to Medical Monitor, Team leader In Order to ensure trial is conducted as per protocol and ICH-GCP guidelines.
2. Identification of new investigators: Identifying new investigator for the trial from different database, contacts with sites. Doing proper feasibility to the site. In Oder to ensure the site recruits the patient properly and conduct studies as per the guidelines and protocol.
3. Budget negotiation: Negotiating the trial budget with the sites to maintain uniformity within sites In order to ensure smooth budget negotiation process.
Experience:3 - 7 YearsLocaion: Hyderabad / SecunderabadOpenings: 1
Desired Profile
Education:UG -, MBBS - Medicine, B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
For More details
https://www.naukri.com/job-listings-Clinical-Research-Associate-Dr-Reddys-Laboratories-Ltd--Hyderabad-Secunderabad-3-to-7-years-281116003008?src=jobsearchDesk&sid=14843703711449&xp=2&qp=,%20clinical%20research%20associate&srcPage=s