Clin RSCH CRD Sr NEX
Employment Type: Full-Time
Senior Clinical Research Coordinators (Senior CRCs) 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. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both National Institutes of Health - 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 (CHR), human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, Food & Drug Administration - FDA, NIH), exhibiting an in-depth knowledge of specific programs.
Reporting to a Clinical Research Supervisor and the Principal Investigator (PI) or Director, the individual 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; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes. This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.
* Bachelor's degree in related area and/or equivalent experience/training
* Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of employment
* 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
* 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
* Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently in identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals
* 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
Note: Physical/health screening required.
* Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
* 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