Functional Area: Clinical Operations
Job Type: Full Time
Location: San Diego based but remote work will be considered
ABOUT VIRACTA THERAPEUTICS:
Viracta Therapeutics is private biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We will also expand into additional applications to utilize this approach for a range of cancers and virus-associated diseases.
Viracta is seeking a Principal Clinical Research Associate (Principal CRA) to support both ongoing and upcoming Oncology clinical trials. The position will provide a key role in contributing to the oversight of the clinical monitoring function across trials, including CRO monitoring oversight, developing and implementing best practices, and conducting and facilitate data monitoring and cleaning to ensure consistency and quality. The ideal candidate will have extensive experience as a senior CRA in lymphoma clinical trials and the ability to interact effectively with investigators and cross-functional teams. This position reports to the VP, Operations & Strategic Alliances.
- Ensures timely and accurate study-related communication to internal and external study teams.
- Provides oversight CRO monitoring activities to ensure quality and regulatory compliance
- Assists with the review and creation of study-specific protocols, CRFs, manuals, tools, and templates, etc.
- Ensures the investigators adhere to the established clinical protocols, regulatory requirements, and Good Clinical Practice, and provides input into data validation.
- Attends and conducts site visits, primarily to provide CRO/contractor oversight and Sponsor level site engagement
- Conducts on-site and remote monitoring to ensure consistency and quality across studies and to support achievement of company timelines, as needed.
- Assists with the development and implementation of site-specific recruitment plans.
- Assists with site feasibility, qualification, and selection process; conducts site monitoring visits, manages study monitoring schedule in collaboration with the CRO, audits CRFs for conformity to source documentation, assess and improve monitoring performance of CRO.
- Sets data entry and monitoring related target timelines and oversees adherence to timelines.
- Manages and helps create monitoring and site management related clinical trial tracking metrics and reporting for internal and external collaborators.
- Participates in selection and management/oversight of external vendors and assists in developments of vendor specifications.
- Bachelor’s degree in Biology, Biochemistry or other life science field of study; or an LVN, RN, PA, or other licensed health care professional degree.
- Minimum 5 years of experience directly supporting oncology clinical research trials with a pharmaceutical company or CRO.
- Experience in global lymphoma clinical trials, preferably in lead CRA or similar role
- Ability to travel up to 20% of time to clinical sites.
Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to firstname.lastname@example.org and include the job title in the subject line. No recruiters please.