Pune; Research Associate / Sr. Research Associate (Clinical Research); B.Pharm, M.Pharm; Synapse Labs

Experience: 1 - 3 Years
Location: Pune
Desired Candidate Profile

•B.Pharm / M. Pharm with 1-3 years experience in BA/BE studies preferably in a CRO environment
•Should have good knowledge about GCP/ICH/FDA regulations
Job Description
•Preparation of trial master file
•Completion of all assigned projects with in the timelines
•Coordination with all the study personnel during study
•Monitor all the study related activities with compliance to the Protocol, Synapse SOP’s and regulatory requirements
•Proper compilation and review all study related documents
•Train the study personnel on Protocol and SOP’s
•Preparation and Review of SOP’s according to the regulatory requirements. Train the study personnel on SOP’s and new system development.
•Ensure compliance with clinical protocols and overall study objectives
•Coordination with all study personnel, coordination with concerned heads for system development during study activities and coordination with sponsor monitor during study activities. Respond to sponsor monitoring visit findings.
•Design of ICF’s, CRF’s and other protocol related documents
•Informed consent procedure, check-in, check-out, Blood sample collection monitoring
•Ensure smooth conduct of the clinical phase of the study, responding to QA Audit finding (both in process and retrospective),
•Handling of post study follow up of subjects
•Ensure all withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs.
•Ensure whether all adverse events (AEs) are appropriately reported within the time periods required by Good Clinical Practices (GCP), the protocol, the Ethic Committees (IRB/IEC), the sponsor, and the applicable regulatory requirement(s).
•Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.
Checking the accuracy and completeness of the case report forms (CRF) entries, source documents and other trial-related records against each other.

Company Profile

Synapse Labs is one of the fastest & growing Contract Research Organization having office in Pune and UK. The Company is providing contract research services to pharmaceutical & Biotechnology Industries

Synapse Labs offers services in Bioavailability / Bioequivalence Studies, Clinical Research (Phase II-IV), Data Management, Biometrics as well as formulation development and much more

send resumes to: careers@synapselabs.com