other
Posted May 4Sr. Centralized Study Coordinator
at Fortrea
Bangalore, IndiaOn-site
Responsibilities
- Maintain study databases (CTMS, IWRS, EDC, etc.) Support study team in e-TMF management activities.
- Support study team in data review and support activities.
- Perform Access management on applicable study systems Perform study system set up on new awarded studies.
- Manage project communications.
- Perform Invoice QC and Prepare GIA as applicable.
- Coordinate with CTL, PM for line item approvals and GIA approval.
- Perform payment reconciliation during the study close out or on adhoc request by the study team: To follow all applicable departmental Standard Operating Procedures and Work Instructions.
- To complete Other duties/activities as assigned by study management team, but not limited to: Manage clinical systems and access management.
Requirements
- To complete required trainings according to required timelines.
- Qualifications (Minimum Required): University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex.
- Nursing certification, Medical or laboratory technology). 02-03 years of work
- experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations. Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements. Fluent in English, both written and verbal.
- experience in the job discipline. 00-03 Years of
- experience in other professional roles.
- Other required work-related experiences: Demonstrated ability to organize and communicate effectively.
- Demonstrated ability to pay attention to detail.
- Ability to work well with others.
- Ability to use computer and departmental tools.
Additional details
- Data Review: Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.