Clinical Research Associate

Job Description

Vasta Bio-Informatics Private LimitedMAHARASHTRA Posted On 20 Jun 2025 End Date 31 Jul 2025 Required Experience 1 - 3 Years Basic Section No. Of Openings 2 Grade C1B Designation Clinical Research Associate Closing Date 31 Jul 2025 Organisational Country IN State MAHARASHTRA City NAVI MUMBAI Location Navi Mumbai-I Skills Skill PHARMACOVIGILANCE CLINICAL RESEARCH MEDICAL WRITING ONCOLOGY CLINICAL DEVELOPMENT CRO GCP EDC CLINICAL DATA MANAGEMENT ICH-GCP Education Qualification No data available CERTIFICATION No data available Job Description Job Title: Clinical Research Associate Department: Delivery Job Location: Navi Mumbai Reporting To: Lead Job Duties / Responsibilities: Project and Operations Management- Responsible for the management of designated clinical trials, preparation of trial related documentation per protocol and Case report forms (CRF). Ensure completeness and submission of data into the data collection form (e.g., electronic CRFs, cancer research database (CRDB), PC-based systems, remote data entry) as per protocol requirements and time lines. Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion and in compliance with ICH-GCP guidelines. Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment. To significantly improve quality assurance and consistency in electronic data capturing and data. Participate in global conference calls and meetings to review progress of ongoing clinical trials. Proficient in the knowledge of protocol monitoring activities. Verify that the investigator followed the approved protocol and all GCP procedures. Communicate any observations to the sponsor i.e. deviations/violations to protocol, safety alerts, quality issues, etc. that may affect the quality of the protocol. Complete regulatory requirements, as applicable. Education and Experience: Bachelors/ Masters Degree with minimum 1 year experience in Clinical Trials Management/Protocols or 0-6 months of experience in Clinical Trials along with certification in Clinical Trials / Research. Knowledge of Oncology Specific terminology preferred. Knowledge of EDCs such as Medidata RAVE, Oracle, Inform, etc. strongly preferred. Experience with Industrial protocols and monitoring visits strongly preferred. Hands-on with computer skills Good communication skills – written and verbal Ability to multitask, work under pressure and meet deadlines required