Sr. Clinical Research Associate
Location: Cupertino, CA
The Sr. Clinical Research Associate (Sr. CRA) will perform and coordinate key aspects during the conduct and monitoring of phase 1-3 clinical trials for the DUR 928 project in accordance with GCP/ICH Guidelines and DURECT SOPs. This position will work closely with the other members of the Clinical Development Team (including Medical Monitor, Project Management, Clinical Pharmacology, Regulatory, Legal, Finance and QA) and will also interact with contract Clinical Research Organizations (CROs), Investigator sites, central laboratory vendors and other external vendors.
Main duties and responsibilities
- Participate in all aspects of DUR 928 clinical trials including study start-up activities through close-out.
- Develop and assists in the preparation of all study documents.
- Communicate regularly with clinical investigative site personnel, (including study nurses, coordinators, and physicians), contract research organizations (CROs) and internal DURECT key personnel to ensure clinical project goals are achieved within the team goals and according to SOPs.
- Visit clinical sites and CROs whenever needed.
- Ensure compliance with protocol and project guidelines as well as GCP/ICH Guidelines, consistency w/ Sponsor and CRO SOPs.
- Responsible for participating in program specific weekly teleconferences with CROs. Escalate project issues to the attention of the Clinical Operations Director as well as the Medical Monitor/Project Physician in a timely fashion.
- Track the day-to-day progress of clinical site activities and updates the appropriate.
- Participate in editing and review of clinical study protocols and investigator brochures as needed.
- Review regulatory documents and/or regulatory checklists to ensure completeness prior to study site initiation and study drug delivery.
- Regular review of monitoring reports, EDC screens, data queries, data query resolutions to ensure protocol compliance.
- Perform ongoing data review to ensure safety and high quality data collection, for accuracy and completeness.
- Review qualifications of investigators and site staff and make recommendations for their participation in a clinical study.
- Review of Trial Master Files prior to archiving.
- Coordinate the shipment of study supplies to trial sites as needed.
- Work with Clinical Ops team to manage vendor and site budgets
- Undergraduate degree or RN/BS Degree in Biological Sciences, Biomedical Sciences or related field.
- Must have knowledge of Good Clinical Practices (GCP) and FDA Guidelines and Regulations
- 5+ years of Clinical Research experience for Senior level role
- Prior experience managing CROs and vendors.
- Proficient report writing (e.g., meeting minutes, monitoring reports, evaluation reports, letters to sites or vendors) and verbal reporting
- Strong computer skills (Word, Excel, PowerPoint)
- Must be able to work independently and as part of a team with high degree of professionalism
- Ability to effectively and professionally communicate (written and verbal) at all levels
- Must have keen sense of urgency and time management skills to convey critical issues to supervisor and/or Clinical Development Team
- Some work is performed in a typical office work environment and some work in clinical environment
- Frequent travel required