Clinical Research Coordinator Gastroenterology

The GI Division Clinical Research Coordinator will support clinical research studies centered on liver disease and liver transplantation. This position functions at a fully proficient, journey-level capacity, with responsibility for independently managing, executing, and coordinating research protocols under the direction of the Principal Investigator (PI). The coordinator may also oversee data collection and study operations for multiple simultaneous clinical research projects, ensuring compliance with established protocols, UCSF policies, and regulatory requirements.

Duties may include, management and coordinating the tasks of multiple clinical research studies, 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, assist with training of Assistant CRCs, and assist PI supervisor with oversight of other research staff; 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; and perform other duties as assigned.

% of time Essential Function (Yes/No) Key Responsibilities
(To be completed by Supervisor)

45 YES Study Coordination and Data Collection
* 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.
* 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 other studies and technicians to ensure scheduling efficiency; 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.
* Set up approved studies in APEX, identify all study subjects in APEX to ensure research-related expenses are billed to the study and that the patient's insurance is billed for standard-of-care expenses.
* Review APEX work queue on a daily basis and resolve incorrect patient billing issues.
* Identify non-standard-of-care patient care costs and procedures related to the study, complete a monthly invoice form, and provide it to the research finance analyst (RFA) for payment from the sponsor.
* Prepare check requests for participation in the study as well as for issuing reimbursement for travel, as stipulated in the consent form.

30 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.

5 YES Quality control procedures
* 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.

5 YES Study Implementation
* Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
* Modify data collection instruments.
* Help schedule staff time and coordinate staff schedules.
* Maintain subject tracking systems.

5 YES Specimen Management/ Maintenance
* Arrange the exchange and transport of specimens with collaborating Investigators and staff.
* Oversee incoming data interpreted from samples and ensure it is utilized correctly for analysis and publications.
* Ensure integrity and security of samples.

5 YES Protocol Submissions and Adherence
* Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR 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 CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
* Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

5 YES Regulatory responsibilities
* Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
* Initiate and follow-up on CHR 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.

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., 100%) at the bottom of the column and press F9. The total sum should add up to 100%.)

Required Qualifications

* High School Diploma efficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training
* Attention to detail; strong interpersonal skills; excellent verbal and written communication skills to effectively coordinate with subjects, team members, other departments, and external institutions; and the ability to multitask in a fast-paced environment while working with a diverse subject population
* Ability to work independently, complete projects in a timely manner, and prioritize multiple assignments to ensure essential tasks are completed by deadlines

Preferred Qualifications

* BA/BS degree in physical or biological sciences
* One year of clinical research experience, or a combination of education and experience
* Fluency in the use of the Committee on Human Research (CHR) iMEDRIS system for submission, renewal, and modification of protocols
* Understanding of patient populations to build rapport and assess appropriate and realistic participation in research studies
* Experience with electronic medical records
* Knowledge of UCSF and departmental policies related to reimbursement, research guidelines, confidentiality, and HIPAA regulations, as well as patient safety and confidentiality practices (electronic and hard copy records, patient charts, and communications)
* Knowledge of medical terminology, research policies and guidelines, shipping requirements for infectious substances, database development and analysis, and data management using tools such as Access, Stata, SAS/SPSS, and TeleForm
* Experience applying regulations and guidelines, including:
* Good Clinical Practice (GCP)
* Health Insurance Portability and Accountability Act (HIPAA)
* Protection of Human Research Subjects
* CHR regulations for recruitment and consent of research subjects
* Effective cash handling procedures
* Environmental Health and Safety (EHS)
* Fire Safety Training

Required Qualifications

* High School Diploma efficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training
* Attention to detail; strong interpersonal skills; excellent verbal and written communication skills to effectively coordinate with subjects, team members, other departments, and external institutions; and the ability to multitask in a fast-paced environment while working with a diverse subject population
* Ability to work independently, complete projects in a timely manner, and prioritize multiple assignments to ensure essential tasks are completed by deadlines

Preferred Qualifications

* BA/BS degree in physical or biological sciences
* One year of clinical research experience, or a combination of education and experience
* Fluency in the use of the Committee on Human Research (CHR) iMEDRIS system for submission, renewal, and modification of protocols
* Understanding of patient populations to build rapport and assess appropriate and realistic participation in research studies
* Experience with electronic medical records
* Knowledge of UCSF and departmental policies related to reimbursement, research guidelines, confidentiality, and HIPAA regulations, as well as patient safety and confidentiality practices (electronic and hard copy records, patient charts, and communications)
* Knowledge of medical terminology, research policies and guidelines, shipping requirements for infectious substances, database development and analysis, and data management using tools such as Access, Stata, SAS/SPSS, and TeleForm
* Experience applying regulations and guidelines, including:
* Good Clinical Practice (GCP)
* Health Insurance Portability and Accountability Act (HIPAA)
* Protection of Human Research Subjects
* CHR regulations for recruitment and consent of research subjects
* Effective cash handling procedures
* Environmental Health and Safety (EHS)
* Fire Safety Training