SR. CRC

About the Role

Senior Clinical Research Coordinators independently coordinate and are accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel. The position is responsible for, and critically important to, the overall operational management of clinical research activities.

This role involves implementing a diverse portfolio of research activities for one or more studies, which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository. Positions at this level perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base and substantial leadership skills.

Reporting to a Principal Investigator (PI) or Director, the incumbent may have central responsibility for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts. The role includes strong administration and management leadership of clinical research, research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution.

Responsibilities

• Develop and implement recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads and adjusting strategies to meet goals.
• Oversee the administrative operations of clinical trials programs, including knowledge of recruitment strategies for human subjects.
• Manage clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Analyze complex and non-routine issues requiring innovative solutions.
• Operate effectively in a changing organizational and technological environment.
• Assess and respond to audit risk; develop project plans/schedules and motivate teams to meet deadlines.
• Interpret and apply policies and regulations.
• Prepare and present financial and quantitative analyses, including financial projections and budgets.
• Use database software, such as MS Access or FileMaker Pro, for managing study data.
• Ensure compliance with regulatory and compliance responsibilities.
• Obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of hire.

Requirements

• Bachelor’s degree in a related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities, or equivalent experience/training.
• Significant project and clinical trial management experience or progressively responsible experience in a related position.
• Exceptional analytical skills to evaluate the importance and urgency of problems.
• Excellent interpersonal, verbal, and written communication skills.
• Financial analysis skills for preparing budgets and financial projections.

Preferred Qualifications

• Fluency in spreadsheet software; ability to develop complex spreadsheets independently.
• Demonstrated skills in audit preparation, execution, and follow-up.
• Experience in risk management regarding study subjects, federal and non-federal sponsors, and regulating bodies.
• Experience with grant application procedures, personnel documentation, contract generation, and subcontracting, preferably at UCSF.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.