Opening for Site Start Up - CRA in PPD Pharma - Freshers can also apply

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients

Post: Site Start Up - CRA ( India )

Job Description:
1. Identify potential investigators in collaboration with the Sponsor, Project Manager, Clinical Team Manager and Clinical Management, as appropriate.
2. Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites.
3. As necessary, support the Clinical Submission Specialist(s) with the preparation and submission of regulatory, ethics committee and provincial applications and regulatory packages.
4. As necessary, support the Clinical Submissions Specialist(s) to ensure the proper essential documents are in place prior to trial start-up; to assist in the preparation of Regulatory Compliance Review packages.
5. Facilitate, in conjunction with the Clinical Contracts Specialist(s) the administrative set-up of sites, laboratories, storage facilities, equipment, etc.
6. Enter and maintain trial status information relating to start-up activities onto tracking databases (e.g. CASCADE) in an accurate and timely manner.
7. Provide start-up status tracking and progress reports as required to the Project Manager or Clinical Team Manager.
8. Upon completion of evaluation visits, to clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards.
9. Maintain a working knowledge of ICH GCP, Corporate SOP/WPDs and applicable client SOPs.
10. Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic communication.
11. Facilitate and respond to company, client and regulatory audits where required.
12. Contribute to the start-up team by assisting in preparation of project tools and sharing ideas and suggestions with team members.
13. Support the coordination of country-level feasibility activities, as required, in accordance with agreed timelines.

Additional Information:
Exp: 0-3 yrs
Location: India, any
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Id: 003689