Senior CRA

Department: Clinical Operations

Location: South San Francisco, CA

Pliant Therapeutics is a public, clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), and are currently in Phase 2a clinical trials for these indications. Pliant’s second product candidate, PLN-1474, is an oral, small molecule selective inhibitor of the αvβ1 integrin, in development as a potential treatment forlate-stage liver fibrosis under a partnership with Novartis. The Company also has discovery and development programs in oncology and muscular dystrophies. The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.

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.

Responsibilities

  • 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.

Qualifications

  • Bachelor’s degree required.
  • 6-9 years of experience working with CROs to manage clinical trials in US and ex-US.
  • Experience independently managing vendors (e.g. imaging, central lab, etc.).
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Able to set priorities and juggle multiple demands.
  • Able to think critically and be a proactive problem-solver.
  • Able to work independently while exercising initiative, flexibility and sound judgment.
  • Comfortable working with different levels of the company including senior level management.
  • Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
  • Ability to operate in alignment with Pliant’s values

 

To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/


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