Clinical Research Associate

Job Title:

Department:

Job Location:

Reporting To:

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