Clinical Research Supervisor

Job Summary :

The position of Advanced Lung Disease Clinical Research Supervisor is responsible for the overall operational management of the UCSF Advanced Lung Disease Program’s clinical research activities. Both of these programs are growing substantially and have significant management responsibilities. This position is critically important to the management of the increased clinical research activities. The position of Advanced Lung Disease Clinical Research Supervisor involves direct responsibility for implementing a diverse portfolio of research activities including multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and programmatic clinical research activities such as the clinical database, and biorepository. The Clinical Research Supervisor is a critical position that requires expert and efficient integration of multiple complex programmatic activities. The position requires substantial leadership skills, the ability to effectively work with multiple different 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), and an in depth knowledge of all aspects of the advanced lung disease programs. Under the direction of the Director, ILD Program and the Director of Clinical Trials, ILD Program, the Clinical Research Supervisor will have central responsibility for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of all multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts. The Advanced Lung Disease Programs need strong administrative and management leadership, strong research coordination, and experienced personnel who can ensure optimal efficiency, compliance, safety, employee supervision and management, financial oversight, and contractual expertise. This position is a position of leadership whose main purpose is to ensure that the programs’ clinical research commitments are met and that the program maintains excellence in all its activities.

Required Qualifications :- Bachelor’s degree in related and five or more years of related experience which includes three or more years of supervisory experience and / or an equivalent combination of education and experience. - At least 3 years experience in clinical trial management or equivalent years progressively responsible experience in a related position including regulatory and compliance responsibilities. - Three to 5 years in a Lead or Supervisory role. - Clinical Trial Professional certification from a professional society within one year in position. - Experience serving as a project manager and the ability to develop project plans and schedules and to motivate team members to complete objectives within deadlines. - Demonstrated experience in audit preparation, execution, and follow-up. - Experience using database software, such as MS Access or Filemaker Pro. - Experience with UCSF grant application procedures, personnel documentation and contracts generation, and CARE and UCSF subcontracting. - 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 recruitment goals as needed. - In-depth and extensive knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures. - Project management skills in order to oversee the administrative operations of the clinical trials program. Specifically, s/he must have knowledge of strategies for recruiting human subjects to research studies as well as skills for HR management and financial analysis - Demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets. - Demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets. - Fluency in spreadsheet software and the ability to develop independently complex spreadsheets - A well-rounded knowledge of human resource management. - Previous experience in risk management regarding complicated study subjects, and federal and non-federal sponsors and regulating bodies. - 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 interpret and apply policies and regulations. Preferred Qualifications :- Master’s degree related scientific/medical area. - Certified Clinical Research Coordinator License / Certification : Yes License/Certification :- Clinical Trial Professional certification from a professional society within one year in position.