Description: Pliant Therapeutics is a 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 for progress to meet unmet medical needs for patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.
Position Overview: 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.
- 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