Senior Clinical Research Coordinator

Senior Clinical Research Coordinator

MED-VAMC-INFD

Part Time

86545BR

Job Summary 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. It has direct responsibility for implementing a diverse portfolio of research activities related to the MACS/WIHS Combined Cohort Study (MWCCS) - a collaborative, multi-center, longitudinal study designed to comprehensively investigate the impact of chronic health conditions-including heart, lung, blood, and sleep disorders-that affect people living with HIV. 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, Investigational Review Board (IRB), human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs. The Sr. CRC will coordinate the data collection and operations of several concurrent clinical research sub-studies related to MWCCS. Reporting to Associate Project Director or a Principal Investigators (PIs), the incumbent may have central responsibility for ensuring IRB approval and compliance, for assigned sub-studies, 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. The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. The salary range for this position is $41.72 - $67.10 (Hourly Rate). To learn more about the benefits of working at UCSF, including total compensation, please visit: Department Description The Department of Medicine (DOM), the largest department in the School of Medicine, has close to 600 full‑time faculty leading top‑notch research, clinical, and education programs. The Department has a decentralized organizational structure across four sites (Parnassus, ZSFG, SFVAHCS and Mt. Zion) and 38 divisions. Authority and accountability for the Department rests with the Department Chair who heads the Parnassus and Mt. Zion sites, and also directs the Vice Chairs at the ZSFG and SFVAHCS sites. The San Francisco Bay Area site of the MACS/WIHS Combined Cohort Study (MWCCS) is funded by the National Institutes of Health and is a collaborative, multi‑center, longitudinal study designed to comprehensively investigate the progression of HIV infection in women and men. The research consortium is comprised of clinics in San Francisco and Oakland and a subsite at the University of Southern California (USC). About 480 adult men and women with and without HIV will be enrolled in the San Francisco and USC study sites. In addition to the parent MWCCS study, participants may also be enrolled in a number of sub‑studies associated with the MWCCS; some of which are independent linked NIH or equivalent grants. Required Qualifications BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to perform the assigned duties and responsibilities. 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 RedCAP, MS Access, or GEMINI. Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi‑task in a fast‑paced environment while working with a diverse subject population. Fluency in the usage of Investigational Review Board (IRB) online iris system for submission, renewal, and modification of protocols through this system. Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines. Preferred Qualifications Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow‑up. Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation. Knowledge of location specific and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the location's mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Salesforce Applications. Experience in risk management regarding study subjects, federal and non‑federal sponsors and regulating bodies. Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals License/Certification 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. About UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate‑level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10‑campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells. Pride Values UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values. In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu. Join us to find a rewarding career contributing to improving healthcare worldwide. Equal Employment Opportunity The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. Job Information Organization: Campus Job Code: 007889 CLIN RSCH CRD SR NEX Job Category: Research and Scientific, Supervisory / Management Bargaining Unit: University Professional Technical Employees - Research Support Professionals Unit (UPTE‑RX) Employee Class: Career Percentage: 75% Location: Oakland, CA, San Francisco, CA Campus: Various Work Sites Work Style: Fully On‑Site Shift: Days, Variable Shift Length: Variable Additional Shift Details: Monday‑Thursday, variable 8am‑4:30pm #J-18808-Ljbffr University of California - San Francisco