Clinical Research Coordinator - Endocrinology (Part-Time)

University of California, San Francisco • San Francisco, CA

2d • Hybrid

About The Position

This 50% position (20 hours per week) will involve conducting on-site study visits at UCSF Benioff Children’s Hospitals in San Francisco (Mission Bay) and Oakland. Flexibility is required, since the needs of the study will determine the work location and the number of hours worked on any given day. Duties include conducting study visits, participant recruitment, data entry, regulatory maintenance, conducting monitoring visits, submitting to the Institutional Review Board, and other study coordination duties. This position is 20 hours per week, primarily Monday through Friday. The number of hours worked per day varies each week depending on the needs of the studies. Most study visits start in the morning (you would arrive onsite at UCSF in either San Francisco Mission Bay or Oakland around 7:30am). Some remote work may be possible depending on the needs of the studies and current department policies. There are occasional evening hours (6 or 7pm) and very rare weekend hours to accommodate our patients’ schedules, usually for a phone call to discuss the study (usually done remotely). There is the possibility of increasing the number of hours per week in the future. The Clinical Research Coordinator (CRC) under general direction, independently manages and coordinates research protocols mainly for children with hormone conditions. They 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); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. Responsibilities include overseeing multiple clinical studies, ensuring regulatory compliance, managing data and documentation, supporting IRB submissions, maintaining data quality, coordinating staff activities, and participating in audits while adhering to UCSF policies and research guidelines. CRC 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; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator’s protocols in the Institutional Review Board (iRIS) 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. Other duties will include recruiting participants for multiple studies in pediatric endocrinology, including contacting participants by phone, email, Zoom/video, or in person. The majority of these studies will require working closely with other researchers, hospital clinic staff, children and their families, onsite, at both Benioff Children’s Hospitals in San Francisco (West Bay) and in Oakland (East Bay).

Requirements

• High School Diploma; or equivalent experience
• Excellent verbal and written communication, organizational, and interpersonal skills to work effectively in a diverse team
• 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 multitask 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
• Proficiency with Microsoft Word, PowerPoint, Excel, Outlook, 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
• Ability to establish cooperative working relationships with patients, co-workers, & physicians
• Experience and/or comfort working with children, adolescents, and families

Nice To Haves

• Pediatric research experience
• Career interest in working with children and/or adolescents and their families
• Fluency in the usage of Institutional Review Board (IRB) online iRIS 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 accessing electronic medical records and entering the data into REDCap and other platforms
• 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

Responsibilities

• 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.
• 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.
• Staff training: 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 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 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. 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.
• Study Implementation
• Specimen Management/ Maintenance
• 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.
• 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.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: High school or GED