Clinical Research Manager

Job Summary:

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

The candidate will be is tasked with managing and facilitating the day-to-day operations of their direct reports (~2-3 clinical research coordinators). The Clinical Research Manager 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 Clinical Research Manager is responsible for resolving operational, workload, protocol implementation, and data collection issues. The candidate will be a proven team-player with project management skills and mindset and have the ability to consistently deliver results on a tight timeline. The Clinical Research Manager 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 incumbent will be a team player and assist with projects, patient coverage, and other CRC duties whenever necessary.

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 Manager will identify areas in need of training and development, review, and refreshers.

Department Overview:

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.

Required Qualifications:

• Bachelor''s degree in related area and / or equivalent experience / training
• 2+ years of related and lead / supervisory experience and / or equivalent experience / training
• Clinical Trail 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.
• Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
• Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in hematology/oncology.
• NCI/CTEP requirements of clinical trials programs, especially in terms of reporting adverse events.
• Prior experience with various computer programs, like Microsoft Office, and clinical trial management systems.
• At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution
• Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
• Supervisory experience or demonstrated experience in training others, particularly in the field of research.
• Experience working with sensitive populations, preferably with oncology patients.
• Ability to cultivate relationships with multiple stakeholders at various levels of administration
• Must possess a solution-oriented attitude and be adaptable to quickly changing priorities.
• Have excellent interpersonal skills, including but not limited to: communication, problem-solving, teamwork development, leadership, mentorship.

Preferred Qualifications:

• Advanced degree preferred
• Certification as a clinical trial professional from one of the professional societies, such as ACRP or SoCRA and has attended any of their seminars.
• Prior experience in clinical research in various areas of oncology, particularly in medical oncology, lab based research
• Prior experience with UCSF, particularly with research in the oncology setting, clinical trial billing, and institutional policies for study compliance and regulation.
• Prior experience working with OnCore, EPIC (APEX), and other data management systems.

Key Responsibilities

% TIME

Is Essential

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.15%[X]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.10%[X]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.20%[X]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.10%[X]

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.

15%[X]

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.

10%[X]

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.

5%[X]

Oversees the incoming data interpreted from samples and ensures that it is correctly entered into respective databases, and reviewed. Ensures

integrity and security of samples.

5%[X]

Recommends salary actions, promotions, and terminations. Recommends personnel-related actions. Participates in the recruitment and

orientation of new employees.

5%[X]Evaluates assigned staff performance and reports5%[X]Key Responsibilities

% TIME

Is Essential

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.15%[X]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.10%[X]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.20%[X]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.10%[X]

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.

15%[X]

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.

10%[X]

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.

5%[X]

Oversees the incoming data interpreted from samples and ensures that it is correctly entered into respective databases, and reviewed. Ensures

integrity and security of samples.

5%[X]

Recommends salary actions, promotions, and terminations. Recommends personnel-related actions. Participates in the recruitment and

orientation of new employees.

5%[X]Evaluates assigned staff performance and reports5%[X]