Clinical Research Professional
At GenesisCare, we are passionate about innovation and working together to drive better life outcomes for patients worldwide.
Job Description:
Monitor clinical trials ensuring projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.
Responsibilities:
* Act as a member of the project team contributing towards efficient trial management.
* Perform site qualification visits, discuss protocol, study documentation, and requirements with investigators and other trial staff.
* Support feasibility, site selection, and start-up activities, including preparing Human Research Ethics Committee submissions.
* Negotiate site budgets and assist with contract execution with support from the Project Manager.
* Perform site initiation visits, train investigators, and other trial staff in the protocol and data collection methods.
* Perform interim monitoring visits, ensure adherence to protocol, monitor participant source data via source document verification per the monitoring plan.
* Perform site close-out visits.
Requirements:
* An undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
* At least 3-4 years' experience in monitoring clinical trials in CRO, Pharmaceutical, and/or Biotechnology industry as a Clinical Research Associate/Professional.
* Experience in managing early phase oncology trials is highly preferred.
* Experience in Electronic Data Capture and Clinical Trial Management Systems.
* Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
Benefits:
* Opportunities to develop professionally.
* Exposure to early site engagement and relationship building.
* Collaboration with sponsors on assigned projects.
* Internal and external training opportunities.