Clinical Research Coordinator

The Clinical Research Coordinator (CRC) will join the Radiology CRC Core within the UCSF Department of Radiology and Biomedical Imaging. The Radiology CRC Core is a team of personnel that provide expertise in conducting clinical research studies, including study setup, execution, management, IRB submissions, clinical research rates, and other research-related activities.

The CRC will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI).

Duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; coordination, recruitment and enrollment of research subjects; data collection, data entry, data transfers, and data management; act as intermediary between services and departments; assist with training of Assistant CRCs and other CRC team members, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; other duties as assigned. 

This work may involve travel between different imaging centers at multiple UCSF campuses as well as interacting with study physicians, researchers, technologists and patients. Studies that the CRC may be involved with include both investigator-initiated and industry-initiated clinical trials. The incumbent may be assigned a variety of studies within the various clinical sections of Radiology such as Abdominal Imaging, Breast Imaging, Cardiac & Pulmonary Imaging, Interventional Radiology, Molecular Imaging & Therapeutics, Musculoskeletal, Neuroradiology, Neurointerventional Radiology, and Pediatric Radiology. The Core also collaborates on studies with investigators in other departments such as neurology, endocrinology, oncology, nuclear medicine, radiation oncology, and the UCSF HDFC Cancer Center.

% 

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

40%

Patient Recruitment & Visit Coordination

• Work with investigators to screen potential research subjects to determine suitability for research studies
• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Recruit subjects for research studies via phone or in person at various UCSF clinics
• Collaborate with multiple departments to ensure study subjects are scheduled on the correct imaging resource

• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.

• Meet and guide patients through research imaging visits

• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.

• Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.

• Travel between UCSF campuses to meet patients for their imaging visits

30%

Data Collection & Management

• Complete research Case Report Forms and enter data into research databases
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
• Administer questionnaires, collect medical history and coordinate study procedures
• De-identify and transfer imaging data to study sponsors in accordance with department and UCSF policies
• Resolve queries relating to imaging data and case report forms
• Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
• Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI.  
• Maintain data collection forms for effective data collection, entry, and analysis.  
• Perform queries and analysis in databases.
• Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
• Arrange the exchange of and transport of specimens with collaborating Investigators and staff.
• Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
• Ensure integrity and security of samples.

15%

Study Management

• Keep track of multiple study protocols
• Coordinate clinical studies including IRB submissions, data analysis, data reporting, facilitating sponsor visits, and subject tracking
• Act as liaison to study sponsor and collaborators
• Help prepare for audits/monitoring visits by sponsors and/or regulatory agencies
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Enter existing and new study protocols into the Committee on Human Research (IRB) online system; seek assistance on maintaining all protocols in the system by communicating with IRB Analysts.
• Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
• Participate in the review of protocols and related procedures to ensure institutional review board approval within University compliance.
• Renew, modify, and submit IRB applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between IRB and study Investigators.
• Provide quality assurance checks to note if protocols or UCSF IRB applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

10%

Quality Control & Regulatory Adherence

• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.  
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures
• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Initiate and follow-up on IRB submissions and modifications; track approval status.
• Interface with departments to obtain UCSF approval prior to study initiation.
• 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.

5%

Miscellaneous

• Monitor study supply inventory and reorder as needed; maintain research charts and study binders; and perform other related duties as assigned.
• Attend group and departmental meetings

100%

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Strong accuracy and attention to detail
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Proficiency with Microsoft Word, PowerPoint, and Windows
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.

Preferred Qualifications

• B.A. or B.S degree with a major in science or related
• Demonstrated proficiency with medical terminology
• Experience working with patients or study subjects
• Training/experience in the conduct of clinical research trials in an academic research environment
• Familiarity with UCSF processes and systems; experience and knowledge of IRB policy and procedure.
• Related lab/research experience
• Experience running clinical research studies, with a strong understanding of Institutional Review Board (IRB) protocols 
• Experience with establishing/running a clinical trial
• Experience with data entry and cleaning
• Navigating study procedures, experience with consents, reviewing eligibility criteria, reporting of safety listings, entering of data and orders into medical record system, coordination and scheduling of hospital visits and follow ups with participants and study staff
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• Demonstrated proficiency with medical terminology.