Clinical Research Associate
Clinical Research Associate
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1 Vacancy
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
Required Experience:
IC
Employment Type
Full Time
