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.

Job Responsibilities:

• 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 m.jacobs@proclinical.com

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.

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