Clinical Trial Coordinator

At a global scale, you will discover meaningful work that makes a positive impact on the world.

Our Clinical Operations team provides end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

• - Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA, and study CTM.
• - Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines.
• - May be assigned limited site contact activities during study start-up, site management, recruitment, and close out phases.

- A day in the Life:

• - Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
• - Completes and documents study-specific training.
• - Orients and trains on any CRG/study-specific systems.
• - Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• - Supports customization of Site ICF with site contact details, as needed.
• - Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• - Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• - Reviews patient-facing materials and reviews translations, as directed.
• - Supports site staff with the vendor-related qualification process, where applicable.
• - Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
• - Provides support to follow-up on site staff training, as applicable.
• - Coordinates and supports logistics for IM attendance, as directed.
• - Supports maintenance of vendor trackers, as directed.
• - Coordinates study/site supply management during pre-activation and subsequent course of the study.
• - Supports Essential Document collection, review, and updating in systems, as applicable.
• - Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
• - Supports ongoing remote review of centralized monitoring tools, as directed.
• - Supports Site payments processes by coordinating with various functional departments within organization and site.
• - Supports system updates and reconciliations, as directed, and follows up on site invoices throughout the study period.
• - Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs, and safety reports, as applicable.
• - Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
• - May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
• - Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Job Complexity: Works on problems of limited scope.

Required Skills and Qualifications:

• - Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Benefits:

This role offers opportunities to grow professionally and personally. We are committed to creating an inclusive environment that allows everyone to thrive and reach their full potential.