PRA Health Sciences, providing innovative solutions for our clients is what we do. Side-by-side with our clients, we strive to move drug discovery forward, helping them to develop life-saving and life-improving drugs. With our unique blend of expertise, we provide comprehensive clinical development services across all phases. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
Post : Clinical Trial Assistant
Job Description:
The Clinical Trial Assistant (CTA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the CTA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
The Clinical Trial Assistant (CTA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the CTA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
Candidate Profile
The CTA would require substantial experience using computerized information systems, electronic mail, word processing and electronic spreadsheets required. He/she would also need to have prior experiences in EC/IRB submissions. A thorough knowledge of ICH and local regulatory authority drug research and development regulations is also required
The CTA would require substantial experience using computerized information systems, electronic mail, word processing and electronic spreadsheets required. He/she would also need to have prior experiences in EC/IRB submissions. A thorough knowledge of ICH and local regulatory authority drug research and development regulations is also required
Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Mumbai
Industry Type : Clinical research
Functional Area : Clinical Trial
End Date : 30th November, 2018
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Mumbai
Industry Type : Clinical research
Functional Area : Clinical Trial
End Date : 30th November, 2018
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