Clinical Associate

7 days ago

Bengaluru, India ICON plc Full time

Recognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- This is a developmental role which requires extensive training. An ability and willingness to travel (drive and fly) as needed for this role and at least 60% of the time for future roles is required.
- *To acquire knowledge of ICH GCP, the conduct of clinical trials and governing regulations, relevant ICON SOPs, ICON internal tracking systems and client SOPs / client systems (when applicable)
- *To assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival
- *To assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study
- *To share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times
- *To facilitate and coordinate ordering/dispatching and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate
- *To assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate)
- To run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly
- To assist in coordination of site/ study related payments, if applicable
- *To contact and serve as a contact for clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
- *To assist in the tracking and distribution of safety reports
- To coordinate document translation, if required
- To assist with, and attend the Project team meetings, and corresponding activities preparation, generation of meeting minutes and agendas
- To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations
- To assist with the coordination of various status and tracking reports including but not limited to team member tracking and training
- To work in collaboration with internal and external colleagues to meet project objectives and timelines
- To keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention
- To maintain client and patient confidentiality
- Other duties as assigned
- Associates degree in nursing
- Bachelor’s degree or local equivalent, in life sciences or related discipline +

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