Clinical Research Manager

Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection.

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator Supervisor for the Department of Surgery in the Breast Care Center Program. Under supervision of the ISPY Program Project Director, the CRC Supervisor is tasked with managing and facilitating the day-to-day operations of their direct reports including training and supervising a team of three to six CRCs. The CRC Supervisor is responsible for training and evaluating CRC performance in executing studies, direct oversight of data collection and reporting, and implementation of protocols within the program that meet federal, state and institutional policies and guidelines.

The CRC Supervisor assists the Director in resolving operational, workload, protocol implementation, and data collection issues for Phase I, II and Phase III studies. The candidate will be a proven team-player with project management skills and mindset and can consistently deliver results on a tight timeline. The CRC Supervisor will work with the Director to develop standard operating procedures and is responsible for training and mentoring CRCs to coordinate studies per Good Clinical Practice, with the goal to achieve optimal efficiency and productivity without jeopardizing patient care and data integrity. The individual will be a team player and assist with projects and patient coverage.

More specifically, the two studies, sponsored by QuantumLeap HealthCare, are the ISPY 2 trial and the DCIS/RECAST trial.

The I-SPY trial involves novel trial designs in the setting of neoadjuvant chemotherapy to accelerate the drug development process. Our goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis, rather than waiting until they develop metastatic disease. Neoadjuvant therapy allows visualization of tumor response to treatment, and thus is the ideal platform to identify mechanisms of resistance, develop diagnostic markers, and individualize therapy.

I-SPY 2, a phase 2 adaptive randomization trial. It is a unique public/private partnership between QuantumLeap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 40 major cancer research centers across the United States and Canada. The DCIS: RECAST Phase 2 trial assesses whether active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease, and is open at 24 locations across the United States.

Department Overview

The UCSF Breast Care Center (BCC) is a nationally recognized leader in breast cancer research. A unit within the Division of Surgical Oncology, in the Department of Surgery, the BCC's clinicians are actively engaged in studies to advance all aspects of breast care including prevention, diagnosis, treatment, and

improving quality of life. They are also engaged in designing new processes for health care delivery, customized to the needs of individual breast cancer patients. The BCC Research Program employs 55+ full-time faculty and staff, as well as associated subcontractors and consultants.

The I-SPY Program (managed within the BCC) involves novel trial designs in the setting of neoadjuvant chemotherapy to accelerate the drug development process. Our goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis, rather than waiting until they develop metastatic disease. Neoadjuvant therapy allows visualization of tumor response to treatment, and thus is the ideal platform to identify mechanisms of resistance, develop diagnostic markers, and individualize therapy. I-SPY 2, a phase 2 adaptive randomization trial process that will test up to 12 new drugs in approximately 800 patients over 5 years. I-SPY 2 is a unique public/private partnership between Quantum Leap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 45 major cancer research centers across the United States and Canada.

%

of time

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)

20

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, CRCs in coordinating clinical studies emphasizing the priority of patient safety and timely data reporting for industry sponsored, and Investigator-sponsored studies while maintaining scientific integrity of the study.

Train, supervise, 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, Open Clinica, and Apex EMR.

20

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.

Acts as resource to CRC, to ensure accuracy in eligibility verification for each patient placed on a clinical trial to ensure human subject protection regulations comply 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.

15

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 forpatients 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.

10

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.

20

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 guide 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 guide 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 guide 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

Yes

Recommends salary actions, promotions, and terminations.

Recommends personnel-related actions.

Participates in the recruitment and orientation of new employees.

Evaluates assigned staff performance and reports to management.

Provides guidance and excellent judgement. Seen as a role model by assigned staff.

5

Yes

Act as backup for CRCs to cover operation as needed, and may have 1-2 patients on study to maintain skills for this difficult trial.

100%

Required Qualifications

• Bachelor's degree in related area.

• Two years of experience with breast cancer clinical trial coordination; minimum of one year of related experience; minimum of one year of Lead/Supervisory/Manager experience.

• Working knowledge of clinical or laboratory research, including clinical trial recruitment, eligibility, protocol adherence, quality data submission, and adverse event reporting.

• Ability to manage multiple priorities, prioritize projects, adapt to changing priorities, and meet the demands of a fast-paced and dynamic work environment.

• Demonstrated skills in employee supervision and HR administration, including experience training others, particularly in research.

• Critical thinking and problem-solving skills to evaluate issues and identify potential solutions.

• Clear and concise verbal and written communication skills.

• Strong interpersonal, teamwork, leadership, mentorship, and motivational skills; ability to cultivate relationships with multiple stakeholders at various levels of administration.

• Ability to perform commonly applicable word processing and spreadsheet functions; effectively use campus clinical information and documentation applications; proven ability using clinical trial management systems.

License/Certifications

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

Preferred Qualifications

• Advanced degree.

Required Qualifications

• Bachelor's degree in related area.

• Two years of experience with breast cancer clinical trial coordination; minimum of one year of related experience; minimum of one year of Lead/Supervisory/Manager experience.

• Working knowledge of clinical or laboratory research, including clinical trial recruitment, eligibility, protocol adherence, quality data submission, and adverse event reporting.

• Ability to manage multiple priorities, prioritize projects, adapt to changing priorities, and meet the demands of a fast-paced and dynamic work environment.

• Demonstrated skills in employee supervision and HR administration, including experience training others, particularly in research.

• Critical thinking and problem-solving skills to evaluate issues and identify potential solutions.

• Clear and concise verbal and written communication skills.

• Strong interpersonal, teamwork, leadership, mentorship, and motivational skills; ability to cultivate relationships with multiple stakeholders at various levels of administration.

• Ability to perform commonly applicable word processing and spreadsheet functions; effectively use campus clinical information and documentation applications; proven ability using clinical trial management systems.

License/Certifications

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

Preferred Qualifications

• Advanced degree.