Dr. Reddys Laboratories is Hiring For Clinical Research Associate and has issued notification to accept Applications. Dr. Reddy€™s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Application form link provided at the end of post. Eligibility for the Clinical Research Associate as follows.
Vacancy summary details :
- Company Name: Dr. Reddys Laboratories
- Location: Hyderabad
- Post Name: Clinical Research Associate
- Qualification: M Pharm
- Experience: NA
- No of Vacancies: NA
- Details of Salary:NA
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
Job Description/Skills Required:
- Responsible to coordinate the implementation of clinical protocol and documentation at the assigned sites in accordance with GCP, company/sponsor SOPs (as applicable), and Applicable regulatory requirements.
- Assist in the conduct of feasibility studies.
- Assist in the preparation and finalization of Confidentiality Agreements and Clinical Trial Agreements.
- Co-ordinate start-up activities and ensure timely IRB/ IEC submissions (initial and subsequent approval, annual status reports, etc).
- Prepare Investigator Site File (ISF) as well as in-house study files, compile and review the regulatory documents of the sites as per the filing structure approved for the study
- Coordinate with the assigned sites to procure documents required for regulatory submission (e.g. CV and undertaking of the Investigator, IRB/ IEC approval, etc.) and review them.
- Coordinate with assigned sites and assist in conducting the Investigator meeting.
- Coordinate, schedule, and conduct site initiation, routine monitoring, and closeout visits as per protocol and monitoring plan.
- Verify whether the most updated IRB/ IEC approved informed consent forms are used by the site during the consent process and the informed consent process is appropriately documented for each study patient
- Review source document and verify against the electronic case report forms (e-CRFs) for completeness, accuracy, and compliance.
- Generate manual data correction forms; assist the site in the resolution of these queries as well as Data Management queries
- Ensure that non-serious and serious adverse events are documented and reported in
- Compliance with safety reporting procedures/timelines.
- Reconcile regulatory documents filed in the ISF with in-house study files during the monitoring visits to ensure availability and accuracy.
- Escalate the non-compliances identified at the site to the applicable stakeholders within the defined timelines and implement the recommended corrective and preventive action in consultation with the Project Manager/ Operations lead.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.