Job Description

Member of the Study Management Team supporting the Clinical Operations team in the management of startup, maintenance, and close-out activities of ORIC clinical trials as well as vendor and system management as applicable.

Essential duties and responsibilities include the following.

• Assist in management of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA requirements
• Assist in the development, review, distributing, and archiving of study specific documents and reports (plans, training materials, study guides, manuals, etc.)
• Assist with updating and maintaining clinical systems and any reporting tools.
• Working with cross functional study teams, and vendors to assist in the coordination of clinical trial activities (including but not limited to):
  • Assist in regulatory document collection and review
  • Assist in ongoing quality oversight of CRO-managed TMF
  • Assist in verifying monthly accruals from vendors and study sites
  • Review patient diaries, drug accountability forms, study and investigator manuals, and monitoring plans.
  • Supports meeting logistics (eg schedule meetings, distribute agendas and drafts/review minutes)
• Review department specific procedural plans
• Develop and maintain good working relationships with internal and external team members, inclusive of Investigators and site study staff.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Qualifications

Education and Experience:

• BA/BS with science major (preferable), or an equivalent combination of education and related experience
• At least 2 years of relevant experience in clinical operations in pharmaceutical/biotechnology company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3)
• Must be able to thrive in an entrepreneurial, fast-paced, and dynamic work environment
• Must be organized and be able to communicate effectively
• Demonstrated excellence in trial management skills, with track record of successfully managing multiple tasks and priorities
• Experience working with study vendors (eg, CRO, IRT/IXRS, laboratories), contract and budget management not required but preferred
• Ability to work well with global, multi-disciplinary teams
• Experience in practical knowledge and implementation of ICH-GCP guidelines (US and ex-US regulations)
• Excellent oral and written communication skills
• Up to 10% travel

Additional Information

The anticipated hourly pay range for candidates is between $27-$31/Hour The final pay rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on __race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or __any other legally protected characteristic.