Job Description

We are looking to hire a Clinical Research Supervisor to help develop, shape and grow the clinical research team. The research program is a fast-paced environment and the successful candidate will be an independent, detail-oriented individual with drive and focus.

The candidate will be a proven leader with project management skills and mindset, experience in oncology clinical trials, and have the ability to consistently deliver results on a tight timeline. The candidate will have leadership skills and training experience to provide operational leadership to a group of Clinical Research Coordinators (~ 3-6 direct reports), while monitoring workload and productivity.

Under the direction of the Clinical Research Manager, the Clinical Research Supervisor is responsible for strategic planning in order to meet program goals, along with ensuring all reporting and study milestones are met including recruitment targets, data entry timelines, budget and sponsor requirements. This position also requires the candidate to be responsive to Principal Investigators and scientific oversight committees. Experience collaborating with senior leadership and research staff is a plus.

The success of the team is dependent on managing performance, maintaining morale, upholding consistency across disease programs in terms of workload and assignment management, as well as maintaining high quality customer service. To achieve service quality, the Clinical Research Coordinator Supervisor will work closely with staff to identify areas in need of training and development, review, and refreshers.

The Clinical Research Supervisor's duties may also include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies), depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain relevant regulatory documents in partnership with the Regulatory department; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

DEPARTMENT DESCRIPTION:

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of "comprehensive" from the National Cancer Institute (NCI).
The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

Responsibilities

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

15
Yes
Distributes work. Monitors the progress of work of assigned staff. Researches and resolves issues and discrepancies. Manages subordinates' quality and quantity of work to ensure unit meets its objectives. Reports performance evaluation to management. Supervises the timeliness and quality of data collection, submission and completion. This includes training new study coordinators in collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events and protocol adherence to federal regulations.
• Train, supervise, and provide backup coverage for CRCs in coordinating clinical studies

emphasizing the priority of patient safety and timely data reporting for CTEP, industry

sponsored, and Investigator-sponsored studies while maintaining scientific integrity of the study.

-Train, supervise, and act as a backstop for CRCs for reviewing medical history, performing study procedures, collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events, using medical charts

and electronic records to extract medical information, and utilizing various data collection instruments including databases of sponsored studies, OnCore, iMEDris, and Apex EMR.

15
Yes
Follows internal policies and processes. Supervises assigned staff to ensure compliance. Trains employees on research regulatory processes, database entry, and working with participant families. Implements and maintains defined research study processes.
• Under the supervision of the Clinical Research Manager, assists in eligibility verification for each patient placed on a clinical trial to ensure human

subject protection regulations are in compliance and quality recruitment.
• Acts as resource to CRC in study startup. Helps troubleshoot logistics as needed by CRC and helps conduct and attends all relevant SIV meetings with sponsors and external sites. May be required to complete study start-up independently and then train CRC.

10
Yes
Serves as a liaison between staff and program leaders. Reports work effort to the department. Cultivates communication and teamwork between cross-functional teams working on research.
• Work with Clinical Research Manager and CRC team to implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration to improve efficiency, maximize limited resources, and deliver optimal clinical trial experience for

patients and high quality data.
• Field questions, explore issues, and support CRCs in problem solving on the day-to-day level; recognizes trends and discusses with Clinical Research Manager to ensure that trends are addressed on a broad scale

40
Yes
Initiates a clinical trial study. Oversees and reviews study and helps create systems and forms to ensure research billing, packets for recruitment and calendars are developed. Reviews accrual and eligibility for each patient placed on a clinical trial to ensure human subject protection regulations are in compliance and quality recruitment. Multi-tasks and prioritizes to smoothly coordinate studies and ensure patient safety.
• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Initiate and follow-up on iRIS submissions for single-patient exceptions, adverse event reporting, and protocol violations.
• Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside

departments.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.
• Facilitate start-up and study coordination at external sites for multi-site investigator initiated studies;

5
Yes
Monitors and audits visits. Monitors preparation in order to oversee and assist study coordinators in preparing for audits. Ensures data is sufficient and updated, including all regulatory documentation. Uses computer applications to generate reports and quality assurance of required data entry. Attends all meetings with auditors. Assists staff assigned with monitoring site compliance.
• Trains, supervises, and acts as backstop for CRCs to prepare for monitoring and audit visits, including ensuring all study documents are complete, organized, and current, all data is submitted and queries answered, and all action items from prior visits are completed
• Trains, supervises, and acts as backstop for CRCs to ensure optimal communication with industry, institutional, external site, and cooperative group monitors and auditors
• Reviews and analyzes monitoring and audit reports for industry-sponsored, investigator

initiated, and cooperative group studies to ensure action items are completed
• Identifies and addresses key areas for improvement related to training and performance management
• In conjunction with the Clinical Research Manager, identifies areas where process

improvements are needed

5
Yes
Tracks patient charges and alerts the department on billable triggers to collect money. Understands budget preparation for clinical trials; interprets and trains the study coordinators on how to proceed in proper data research billing. Coordinates with billing to resolve disputed charges.
• Trains, supervises, and provides backup coverage for CRCs to consult and interpret

coverage analyses, communicate billing practices to patients, and properly and in a timely manner route billing of study procedures via electronic billing systems.
• May offload more complicated billing issues from CRCs.
• May collaborate with partners in ancillary departments, including clinic team, billing offices, and information technology team to troubleshoot individual instances of improper billing; communicates with Clinical Research Manager to facilitate recognition of trends and improve processes
• May be responsible for working with Clinical Research Manager and Protocol Project Manager in managing the funds for the study, including assisting with tracking and reporting invoiceables to the post-award team to ensure timely patient

reimbursement
• Provides excellent judgment and initiative to ensure procedures are properly billed to optimize patient care and use of limited resources, may assist Clinical Research Manager in creating systems to ensure these operations are properly

implemented

5
YesRecommends salary actions, promotions, and terminations. Recommends personnel-related actions. Participates in the recruitment and orientation of new employees.
5
YesEvaluates assigned staff performance and reports to management. Provides guidance and excellent judgement. Seen as a role model by assigned staff.
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%.)

Qualifications

MINIMUM REQUIRED:

• Bachelor's degree in related area.
• At least 2 years' experience with industry clinical trials as a CRC.
• At least 2 years of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
• Clinical Trial Professional certification from a professional society within one year in position.
• 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.
• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
• 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.
• Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
• NCI/CTEP requirements of clinical trials programs, especially in terms of reporting adverse events.
• Ability to cultivate relationships with multiple stakeholders at various levels of administration
• Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
• Able to sit and work at a computer for up to 8 hours/day; stand/walk for 3-6 hours; bend/stoop for up to 3 hours; reach for up to 3 hours; repetitive use of upper extremities for up to 8 hours; able to lift and/or carry 25 pounds; able to hear alarms, clients and/or instructions. Ability to see accurately from 20 inches to 20 feet.

PREFERRED:

• Advanced degree preferred.
• Experience and knowledge of medical care and Phase I-III clinical trials, preferably with oncology trials.

LICENSE/CERTIFICATION:

• Clinical Trial Professional certification from a professional society within one year in position.