Clinical Research Coordinator

Job description

The Clinical Research Coordinator (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). The CRC will coordinate the data collection and operations of several concurrent clinical research studies led by different Principal Investigators (PIs), including the Directors of Clinical Research, under the guidelines of research protocols, UCSF and regulating agency policies. Research activities and coordination will be performed at UCSF and ZSFG clinical sites, as well as affiliated spaces/sites based on research project needs.
The 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; 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; assist with coordinating CRC work schedules/coverage; provide organization of CRCs and other research staff when leading projects; support training of CRCs, as well as work-study students or interns (UCSF Undergraduate Research Intern/URI, etc); and assist Maternal-Fetal Medicine/OBGYN/other UCSF faculty and fellows with multiple research projects. The CRC will also manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; 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 all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; assist Clinical Research Supervisor and/or PIs in preparing and monitoring study budgets; and perform other duties as assigned. May perform blood draws if certified.
The CRC will design and develop RedCap databases, enroll patients in research studies, and do chart reviews and data collection for later data analysis. The CRC will work on Institutional Review Board (IRB) applications and submit protocols, regulatory documents, modifications and updates to the IRB for various ongoing studies. This CRC 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 OVERVIEW:
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.
of time (Nothing less than 5%)
Essential Function (Yes/No )
Key Responsibilities
(To be completed by Supervisor)
30%
YES
Study Coordination, Staff Training, and Data Collection
• Coordinate multiple studies with multiple PIs and clinical site leaders across UCSF and/or ZSFG.
• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
• 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.
• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• May perform blood draws if certified.
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
• Coordinate, communicate and network with multiple PIs, study teams, and clinical staff to ensure continued operational efficiency in patient care sites; communicate with any affiliated groups.
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
• Attend and actively participate in regular team meetings

20%
YES
Data Management and Reporting of Results
• 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.

15%
YES
Quality Control Procedures and Regulatory Responsibilities
• 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
• Conduct ongoing review of active studies.
• 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.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.
• Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
• Modify data collection instruments
• Maintain subject tracking systems.
• Assist in preparing and monitoring study budgets and identifying and addressing any potential issues.
• Review and facilitate newly proposed studies
• Assist with implementation through coordination with clinical site leadership
• Conduct in-person recruitment of study subjects on behalf of other study teams
• 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%
YES
Study Implementation
10%
YES
Specimen Management/ Maintenance
10%
YES
Protocol Submissions and Adherence
• Enter all existing and new study protocols into the Institutional Review Board (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 and writing 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.

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%.)
Required Qualifications:
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.

Preferred Qualifications:
• Fluency in the Spanish language.
• 3-5 years of full-time work experience in a related field.
• Valid and current California Certified Phlebotomy Technician 1 (CPT-1) or equivalent license to perform phlebotomy in the State of California.
• Fluency in the usage of Institutional Review Board (IRB) online iMEDris system for submission, renewal, and modification of protocols through this system.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience with electronic medical records.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA 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, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
• 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