Sr. CRA (In-House)
Proclinical is currently recruiting for a Senior CRA with a leading biotechnology company located in San Diego, CA. As the Sr. CRA, you will develop framework for consistency in monitoring oversight across clinical programs.
- Contribute to monitoring plans using a risk-based approach (e.g. Risk Based Monitoring). Provide monitoring and study support resources to all studies.
- Develop framework for consistency in monitoring oversight across clinical programs.
- Review study protocol and study plans from an operational/monitoring perspective and provide meaningful and logical insights into its feasibility and appropriateness.
- Use study monitoring metrics to monitor recruitment, site visits, data quality, patient safety, timely submission of trip visit reports, timely escalation of any monitoring quality issues, etc.
- Contribute to development of patient recruitment strategies and identify barriers to recruitment and proposes solutions.
- Foster relationships with CRO study management and monitor counterparts during all stages of study (start up, conduct, closeout, and query resolution/data cleanup).
- Oversee monitoring and study support team for quality and compliance. Identify issues and escalate any areas of concern, including study conduct or personnel issues. Work with the CRO Clinical Lead/Lead CRA in managing communications and training for CRO CRAs.
- Lead, train and help develop contracted CRAs.
- Ensure consistency in processes across all programs and strict adherence to SOPs, regulations and guidelines.
- Serve as the face of company at monitoring oversight visits. Cultivate site relationships through discussions with PI and site staff. Address all study related questions.
- Perform and oversee SSVs / SIVs / SMVs across programs as needed.
- Manage vendor activities for clinical studies ensuring that vendors are adhering to timelines, budget and are delivering quality.
Skills and Requirements:
- Four-year college experience, such as a bachelor's degree in science, healthcare, or a related field.
- 2+ years of vendor management experience.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or firstname.lastname@example.org
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.