CLIN RSCH SUPV 1

Job Summary:

Please note: This is 1 year contract with potential extension/renewal based on budget

The Clinical Research Supervisor (CRS) position is responsible for implementing a diverse portfolio of research activities. This includes operational management and oversight of multiple study protocols for the Perinatal Research Program, as directed by the Research Program Director, Research Program Manager, and/or Project Managers and Principal Investigators (PIs). Research activities, coordination, and supervision will be performed at UCSF Mission Bay, Mount Zion, and ZSFG clinical sites, as well as affiliated spaces/sites based on research project needs.

The position will perform expert and efficient integration of multiple complex programmatic activities, applying substantial leadership skills, effectively working with a variety of people and organizations (investigators, clinical staff, lab managers, administration, Human Research Protection Program (HRPP), coordinating centers, sponsors, CROs, NIH, and research participants), and exhibiting in-depth knowledge of research operations. The position will be responsible for the supervision of clinical research coordinators; training and mentoring staff in quality improvement measures; coordinating team work schedules/coverage; and managing the day-to-day requirements for multiple research trials.

The position will exercise strong management and leadership of clinical research, rigorous study coordination, quality improvement processes, and will oversee study personnel to ensure optimal systems for efficiency, compliance, and safety. The main purpose of this role is to ensure that research commitments are met and that the program maintains a reputation of excellence in all activities. This CRS role will also promote an environment of equity and inclusion, supporting opportunities for everyone to reach their potential; and advance campus, school of medicine, department, division, and/or funder diversity, equity, and inclusion goals through active participation in planning and implementation of DEI activities.

Department Summary:

The Department of Obstetrics, Gynecology and Reproductive Sciences (OBGYN & RS) is a major academic Department in the School of Medicine, engaged in clinical, research and training activities at Parnassus, Mt. Zion, and the Zuckerberg San Francisco General Hospital campuses; the Betty Irene Moore Women's Hospital at Mission Bay; as well as satellite locations throughout the Bay Area; with an annual operating budget of approximately $150 million. The Department has 111 full-time faculty, 117 other academic appointees, 13 post-doctoral fellows, 20 clinical fellows, 32 residents, 138 voluntary clinical faculty, and 270 staff. The mission of the UCSF Department of OBGYN & RS is to improve the lives and health of all women through excellence, innovation and leadership in patient care, scientific discovery, education, advocacy, diversity, equity, and inclusion. "Leading the way in women's health."

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.

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 here.

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.

Salary Information

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.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Required Qualification:

• Bachelor''s degree in related area and / or equivalent experience / training
• 3+ years of directly relevant clinical research experience.
• 1+ years of lead/supervisor/manager experience.
• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Critical thinking skills to evaluate issues and identify a potential solution.
• Clear and concise communicator; good verbal and written communication skills; both.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus'' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Experience with database development, or data management or analysis with different database or analysis platforms including any or all of the following: RedCap, Access, Excel, Stata, SAS, SPSS, and Teleform programming.

Preferred Qualification:

• Advanced degree preferred
• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
• Fluency in Spanish Language (read, write, speak
• Fluency in the usage of Institutional Review Board (IRB) online iMEDris system for submission, renewal, and modification of protocols through this system
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the UCSF 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
• Experience with setting up and tracking research participant billing. Familiarity with research capitation model and reimbursement logs
• Experience applying the following regulations and guidelines:
• Good Clinical Practice Guidelines
• Health Information and Accountability Act (HIPAA)
• The Protection of Human Research Subjects
• IRB regulations for recruitment and consent of research subjects
• Effective Cash Handling Procedures
• Environmental Health and Safety Training
• Fire Safety Training
• Experience with project management
• Experience working in a clinical research setting

Certifications:

• List Education, Licenses and Certifications a candidate must possess or meet to be considered for the position. You may also select any of these attributes as being preferred.
• These will be included in the job posting/advertisement and will be used to screen applicants

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

50YES

Lead clinical research operations: Develop and implement systems to optimize clinical research outputs and ensure research goals and deliverables are accomplished. Provide guidance and excellent judgement for triage, with competing priorities in a fast-paced clinical research environment. Specific duties may include but not limited to the following:

• Optimize in-clinic processes and procedures for participant recruitment and enrollment
• Multi-task, trouble-shoot, and prioritize work to smoothly coordinate studies and ensure patient safety while reaching study milestones.
• Review the accrual rate of the studies and confirm eligibility for participants enrolled in research studies to ensure human subject protection and regulations are in compliance and results in high quality recruitment.
• Ensure the timeliness and quality of data collection, submission and completion.
• Be a role model and provide coaching to clinical research coordinators. This includes supporting their work with "patients first" principle; facilitate recruitment approaches; participant enrollment; data collection, entry, and management; following research-specific guidelines for proper reporting of adverse events.
• Conduct results-driven monitoring, develop and routinely update study dashboards, share with PRP leadership to inform decision making, problem-solving and prioritization across multiple studies.
• Oversee biospecimen collections, specifically for safe handling, protocol adherence, sample tracking, sample viability, storage, and shipping.
• Ensure data is sufficient and updated, use computer applications to generate reports and quality assurance of required data entry. Includes data entry and tracking across multiple platforms, quality control measures, addressing data queries, and data cleaning.
• Ensure all regulatory practices and documentation are complete and compliant. This includes, but not limited to IRBs, DUA/DTUAs, IDS, and MTAs.
• Cultivate growth, communication and teamwork between cross-functional teams working on multiple research studies.

40YES

Supervise clinical research coordinators: Provide leadership and direct supervision to a team of clinical research coordinators to achieve milestones and goals of research projects, including:

• Develop clinic schedules and provide other systems for appropriate division of labor to distribute work to a team of research coordinators.
• Monitor the progress and quality of work of assigned staff.
• Identify and develop strategies and practices to support: increase efficiencies; personnel growth; and improvement in the efficiency and quality of work of assigned staff.
• Seen as a role model and leader by assigned staff.
• Supervise assigned staff to ensure compliance with UCSF and research regulatory requirements.
• Train employees on research regulatory processes, database entry, and working with participants.

5%YESEvaluate assigned staff performance and report to management. Serve as a liaison between staff and the wider OBGYN Department clinicians/staff and program leaders. Report work effort to the department in conjunction with the Research Managers. 5%YESSupports research project set-up activities such as coverage analysis, ZZ accounts, BearBuy needs, and FedEx accounts.100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

50YES

Lead clinical research operations: Develop and implement systems to optimize clinical research outputs and ensure research goals and deliverables are accomplished. Provide guidance and excellent judgement for triage, with competing priorities in a fast-paced clinical research environment. Specific duties may include but not limited to the following:

• Optimize in-clinic processes and procedures for participant recruitment and enrollment
• Multi-task, trouble-shoot, and prioritize work to smoothly coordinate studies and ensure patient safety while reaching study milestones.
• Review the accrual rate of the studies and confirm eligibility for participants enrolled in research studies to ensure human subject protection and regulations are in compliance and results in high quality recruitment.
• Ensure the timeliness and quality of data collection, submission and completion.
• Be a role model and provide coaching to clinical research coordinators. This includes supporting their work with "patients first" principle; facilitate recruitment approaches; participant enrollment; data collection, entry, and management; following research-specific guidelines for proper reporting of adverse events.
• Conduct results-driven monitoring, develop and routinely update study dashboards, share with PRP leadership to inform decision making, problem-solving and prioritization across multiple studies.
• Oversee biospecimen collections, specifically for safe handling, protocol adherence, sample tracking, sample viability, storage, and shipping.
• Ensure data is sufficient and updated, use computer applications to generate reports and quality assurance of required data entry. Includes data entry and tracking across multiple platforms, quality control measures, addressing data queries, and data cleaning.
• Ensure all regulatory practices and documentation are complete and compliant. This includes, but not limited to IRBs, DUA/DTUAs, IDS, and MTAs.
• Cultivate growth, communication and teamwork between cross-functional teams working on multiple research studies.

40YES

Supervise clinical research coordinators: Provide leadership and direct supervision to a team of clinical research coordinators to achieve milestones and goals of research projects, including:

• Develop clinic schedules and provide other systems for appropriate division of labor to distribute work to a team of research coordinators.
• Monitor the progress and quality of work of assigned staff.
• Identify and develop strategies and practices to support: increase efficiencies; personnel growth; and improvement in the efficiency and quality of work of assigned staff.
• Seen as a role model and leader by assigned staff.
• Supervise assigned staff to ensure compliance with UCSF and research regulatory requirements.
• Train employees on research regulatory processes, database entry, and working with participants.

5%YESEvaluate assigned staff performance and report to management. Serve as a liaison between staff and the wider OBGYN Department clinicians/staff and program leaders. Report work effort to the department in conjunction with the Research Managers. 5%YESSupports research project set-up activities such as coverage analysis, ZZ accounts, BearBuy needs, and FedEx accounts.100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)