Study Management Associate Jobs in San Ramon, CA

Job Summary:

Under the direction of the faculty directors of the Women's Health Clinical Research Center (WHCRC), the Associate Director will independently coordinate and be accountable for the overall administration and regulatory compliance of a portfolio of approximately 10-20 active clinical protocols, including investigator-initiated, industry, and federally-sponsored multi-centered clinical trials, research consortia, and prospective cohort studies that require advanced-level knowledge and skills. The Associate Director will work collaboratively with senior academic faculty and external constituents, including diverse stakeholder groups to launch and maintain operational programs. This position provides administrative leadership within a multidisciplinary research program, across the Department of Obstetrics, Gynecology, and Reproductive Sciences; the Department of Medicine - Division of General Internal Medicine; and other UCSF departments where WHCRC faculty or staff have overlapping appointments. The Associate Director manages WHCRC teams across departments, including governance, staffing, research plan development and grant submission, budget development and management, establishment and oversight of subcontracts and consultant or vendor agreements, and monitoring of the WHCRC's overall operations and portfolio. The Associate Director will supervise the day-to-day activities of all research staff and events, effectively balancing numerous deadlines and evolving priorities.

This position is responsible for and critically important to the development and overall operational management of WHCRC. The Associate Director has direct responsibility for implementing a diverse portfolio of research activities, which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and other programmatic clinical research activities. The position may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated research knowledge base, substantial leadership skills, and effectively working with a variety of organizations at UCSF (Institutional and departmental leadership, clinicians, investigators, clinical staff, senior administration, the Clinical and Translational Science Institute, the Human Research Protection Program, human resources, research management services, finance, and contracts and grants) and elsewhere (industry sponsors, coordinating centers, Data Safety Monitoring Board, FDA, NIH, PCORI), exhibiting an in-depth knowledge of specific programs.

The position will require active management of multiple project workstreams across planning, initiation, execution, and close-out. The Associate Director will establish and maintain effective partnerships with diverse stakeholders, support rigorous monitoring and evaluation of all activities to capture impact and best practices, implement sound financial and administrative stewardship, and disseminate program accomplishments. The fundamental requirements of this position include research operations management, clinical trials/longitudinal studies management, budgetary management/oversight, and HR/risk management/administrative responsibilities. The Associate Director, collaborating with the faculty members, will be responsible for study protocol development, completion of study start-up, clinical trial/study management, data management and integrity, regulatory compliance, and achievement of study objectives. This position will directly supervise multi-disciplinary/level staff personnel, as well as hire, train, and supervise new staff members.

Department Overview:

The Department of Obstetrics, Gynecology and Reproductive Sciences (Ob, Gyn & RS) is a major academic Department in the School of Medicine, engaged in clinical, research and training activities at the Parnassus, Mount Zion, and Zuckerberg San Francisco General Hospital campuses, the new Betty Irene Moore Women's Hospital at Mission Bay, as well as satellite locations throughout the Bay Area, with an annual operating budget of $149 million. The Department has 134 full-time faculty, 117 other academic appointees, 13 post-doctoral fellows, 22 clinical fellows, 32 residents, 138 voluntary clinical faculty and 270 staff.

The mission of the Department of Obstetrics, Gynecology & Reproductive Sciences is to improve the lives and health of all women through excellence, innovation and leadership in patient care, scientific discovery, education, advocacy, and diversity, equity and inclusion. We are committed to providing quality health care services; educating health care providers and investigators; and conducting research to advance knowledge in our field.

Reasonable accommodation(s) to qualified individuals with disabilities are available as part of the application and interview processes. If you would like to request accommodations, please contact the recruiter or hiring manager. If workplace accommodations are needed after a job offer is made, please contact the supervisor and/or Disability Management Services (DMS) at (415) 476-2621 to initiate the interactive process.

REQUIRED:

• Bachelor's degree in related area and 6+ years of experience or any equivalent combination of education and experience. 
• Minimum of 5+ years' prior experience in a supervisory/lead, management or leadership role directly involved in managing staff.
• Minimum of 6+ years experience with OBGYN or Women's Health working environment
• Experience working in an academic medical institution. 
• Clinical Trials Administration
• Broad academic knowledge and applied background in clinical research philosophy. Applies knowledge of theoretical concepts and business best practices in clinical trial and other clinical study settings. Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical studies.
• Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials and other clinical studies. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research.
• Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues.
• Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade.
• Demonstrates excellent problem-solving and analytical skills. Creatively addresses complex or new problems. Proven skills to quickly evaluate complex issues and identify multiple options for resolution.
• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings.

• Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial.

PREFERRED:

• Expert user of the campus' clinical information and documentation application programs. Technical proficiency in project management software.
   

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Key Responsibilities

(To be completed by Supervisor)

Develop, manage and oversee the organizational, strategic, and tactical aspects of the center's clinical research program. Provide operational, clinical, and project management oversight for assigned research. This includes but is not limited to the following: 

• Oversee, direct, and develop WHCRC's research operations, including management of the research projects and staff, work streams, research budgets, contracts and subcontracts, and funding awards.
• Supervise the research team; serve as hiring manager for open positions, in both ObGyn and DGIM, in collaboration with HR, talent acquisition specialists, and finance analysts; propose changes to staffing as needed; execute recruiting, hiring, onboarding, training plans, and ensure new hires meet standards.
• Recommend salary actions, promotions and terminations. Conducts necessary personnel actions for assigned staff, including advancement and disciplinary actions. Propose changes in staffing as needed. Execute recruiting, hiring, and onboarding, ensuring that new hires meet standards
• Implement and administer employee evaluations that meet organization standards. Evaluate assigned staff and define development goals. Promote professional growth and advancement for staff. Train study team and provide certifications for the study.
• Recommend and determine budgetary limitations, the amount of subordinate merit increases, who will be selected for promotional opportunities, and whether to request the reclassification of a position.
• Provide leadership and supervision to the senior clinical research coordinators and clinical research coordinators, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry.
• Maintain staff by identifying professional development and growth opportunities, as well as incorporating development discussions in one-on-one meetings.
• Manage and execute the 3-month mid-probationary reviews, 6-month probationary evaluations, annual performance evaluations, and final ratings.
• In partnership with HR Shared Services/LER and Staff HR Manager, manage any necessary disciplinary processes, which may include issuing written warnings and suspensions, and determining what discipline should be imposed upon a subordinate;
• Formulate and recommend a resolution to grievances or complaints. Implement and administer employee evaluations that meet organization standards. Evaluate assigned staff and define development goals. Promote professional growth and advancement for staff. 
• Facilitate new stakeholder collaborations with WHCRC and onboard new stakeholder-engaged projects
• Perform measurement and evaluation efforts of the goals of the program to ensure program is on track, capture lessons learned, and implement course-corrections to maximize output.

Translate clinical research objectives, policies and procedures into an operational plan. Establish clinical research goals to ensure trial achieves pre-defined sponsor goals, study coordinating center goals and departmental objectives. Develop ways to measure research productivity and quality. This includes but is not limited to the following:

• In collaboration with the Co-Directors and other leadership team members, and leaders both internal and external to UCSF, develop and execute annual work plan goals and objectives.  These include but are not limited to governance, staffing, finance and budget, and donor/funding activities.
• Establish processes for prioritizing areas of research focus for the WHCRC Research Program. Assess ability to execute protocol safely and properly, negotiate pre-study agreements and budgets, work with Research Services Analyst and Industry Contracts to execute agreements, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.
• Represent studies to external committees, partners, corporate / industry partners, regulatory and oversight agencies, and the public as necessary, and in collaboration with the Directors and leadership.
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