Senior Clinical Research Coordinator

The Senior Clinical Research Coordinator (Sr. CRC) for UCSF HDFCCC Breast Oncology department independently coordinates and is accountable for the overall administration of several 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. It has direct responsibility for 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 may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs. 

Directly reporting to the Clinical Research Manager (CRM), the incumbent may have central responsibility in assisting the research team for study start-up and study implementation for pharmaceutical sponsored, cooperative group, and principal investigator-initiated studies. The Sr. CRC must exercise strong administration and management leadership of clinical research, strong research coordination, and may assist in leading less experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and implement quality improvement processes. The incumbent will also assist the Protocol Project Managers with regulatory approvals, budgeting, and study initiation, as needed and directed by the CRM. 

Under the supervision of the CRM, the Sr. CRC position supports the clinical trial management of oncology trials. 

Responsibilities include communicating with the lead program study coordinator to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval; and report study progress to the appropriate PI. The Sr. CRC may support studies with and without active patients as deemed appropriate by the CRM. The Sr. CRC may also lead the coordination of multi-site studies, where UCSF is the lead site. The incumbent supports the investigators in research study project management to assure compliance with the Code of Federal Regulation and the ICH Guidance on Good Clinical Practice as well as UCSF Institutional policies. The incumbent also supports the research team with additional duties as assigned by the CRM. 

The position is a resource and teacher to other CRCs, contributes to the Cancer Center mission, manages more complex studies than the CRC, supports the CRM and fills in during absences. The Sr. CRC is knowledgeable about a variety of electronic databases; acts as a mentor and trainer, and assists with quality assurance activities.

Requirements: - Bachelor’s degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training. - Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals. - In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures. - Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects. - Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills. - Ability to analyze complex and non-routine issues requiring innovative solutions. - Ability to operate effectively in a changing organizational and technological environment. - Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines. - Ability to interpret and apply policies and regulations. - Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets. - Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities. - Experience using database software, such as MS Access or FileMaker Pro. - Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire. Preferred: - 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