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Senior Clinical Research Associate (Sr. CRA)

Company: Pliant Therapeutics, Inc.
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

The Senior Clinical Research Associate (Sr. CRA) is responsible for assisting the Clinical Trial Manager in managing and/or leading the day-to-day operations of assigned study execution tasks to ensure completion per established project team goals and objectives. The Sr. CRA will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

Participate in preparation of vendor requirements and project scope and selection of study vendors.

Manage vendors to ensure timely and quality deliverables (e.g. central laboratory, imaging).

Provide study progress updates to CTM and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.

Provide monitoring oversight through review of monitoring schedules, metrics and reports.

Participate in study monitoring visits, including CRA oversight visits.

Participate in and, if appropriate, facilitate cross-functional study execution team meetings; liaise with other functional areas to coordinate clinical study activities.

Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.

Develop study plans and participate in system set-up (e.g. UAT of EDC, IRT).

Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.

Review clinical study plans, reports, and study metrics.

Participate in study feasibility assessments and selection of countries and sites for study conduct.

Participate in creation and conduct of study-specific training at investigator meetings.

All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with Pliant SOPs.

Keywords: Pliant Therapeutics, Inc., South San Francisco , Senior Clinical Research Associate (Sr. CRA), Other , South San Francisco, California

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