Project Support Coord
Location : Bengaluru, Karnataka, India
Job Id : R-01217297
Job Type : Full time
Category : Clinical Research
Job Description
- Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Follows up for resolution of findings and raises whenever vital.
- Ensures allocated tasks are performed on time, within budget and to a high quality standard. Bring ups in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC’s free capacity
- Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.
- Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, supervising study level documents, maintaining audit readiness and presenting the non-compliance to the study team and suggesting resolution.
- Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG’s/Client eTMF as required, performing CRG’s/ Client eTMF reviews and coordinating and proposing issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes and follow up for closure of action items, if required.
- Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role.
- Maintains and regularly checks for correctness of vendor trackers.
- Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager.
- Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.
Education and Experience:
High / Secondary school diploma/ equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 0 to 4 years).
