Clinical Research Coordinator

UCSF•San Francisco, CA

2d•Onsite

About The Position

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 Associate Director of Clinical Research 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. Incumbent’s 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. 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. Reporting to the Associate Director of Clinical Research, the incumbent may have central responsibility for ensuring IRB approval and compliance, subject recruitment, appropriate study testing, and adequate enrollment for a longitudinal cohort study. The Clinical Research Coordinator (CRC) will work in a highly dynamic research lab with primary focus on studying ovarian aging and the implications on cardiovascular health. The Ovarian Aging Cohort (OVA) the largest, most ethnically diverse, community-based cohort capable of determining the impact of accelerated ovarian aging on general health. The study addresses cardiovascular risk in cycling reproductive age women, rather than what has standardly been considered the increased risk associated with estrogen deficiency and menopause, utilizing the best available markers of ovarian reserve. These tests are being applied in the general gynecology population as screening tests for fertility. The study team aims to test whether ovarian aging can provide a window into long-term risk for cardiovascular disease. If this is shown to be true, wider use of these markers can provide an opportunity to identify asymptomatic women who may be at increased long-term risk. An interdisciplinary team has been assembled who is capable of integrative measurement models ranging from cellular to social. The CRC is tasked with performing duties related to the support and coordination of these studies as well as assisting other team members on group projects. The OVA study will involve the reconstruction of the original cohort (e.g., trace past participants, complete the consenting process, schedule screenings, facilitate multiple appointments); coordinate the data collection and operations of concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. Additionally, the CRC will prepare protocol modifications, when necessary, design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding study participants; apply understanding of inclusion/exclusion eligibility criteria for protocols; recruit, enroll, register, schedule and retain study subjects; record protocol specific treatments and assure collection and shipment of samples; keep patients on study schedules; complete study forms; collect, enter and clean data for study databases, maintain data quality; assist with data analysis; assist with preparation of reports and tables; and attend team meetings. Due to the population that this position will potentially interact with, fluency in Spanish or Mandarin is preferred. The CRC will support this research, as well as other smaller projects involving early determinants of pregnancy, the effects of oxidative stress on assisted reproductive technology, and studies involving wearable technology to understand specific aspects of reproductive health.

Requirements

Perform independently or with general direction at the fully operational journey level of the series.
Coordinate data collection and operations of concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.
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.
Design and develop RedCap databases.
Enroll patients in research studies.
Perform chart reviews and data collection for later data analysis.
Work on Institutional Review Board (IRB) applications and submit protocols, regulatory documents, modifications and updates to the IRB for various ongoing studies.
Promote an environment of equity and inclusion, supporting opportunities for everyone to reach their potential.
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.
Ensure IRB approval and compliance, subject recruitment, appropriate study testing, and adequate enrollment for a longitudinal cohort study.
Reconstruct the original cohort (e.g., trace past participants, complete the consenting process, schedule screenings, facilitate multiple appointments).
Prepare protocol modifications, when necessary.
Design flow sheets, data forms and source documents.
Gather and interpret medical, surgical and laboratory data regarding study participants.
Apply understanding of inclusion/exclusion eligibility criteria for protocols.
Recruit, enroll, register, schedule and retain study subjects.
Record protocol specific treatments and assure collection and shipment of samples.
Keep patients on study schedules.
Complete study forms.
Collect, enter and clean data for study databases, maintain data quality.
Assist with data analysis.
Assist with preparation of reports and tables.
Attend team meetings.

Nice To Haves

Fluency in Spanish or Mandarin is preferred.

Responsibilities

Execute, manage, and coordinate research protocols.
Coordinate data collection and operations of concurrent clinical research studies.
Act as an 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 CRC work schedules/coverage.
Provide organization of CRCs and other research staff when leading projects.
Support training of CRCs, work-study students, or interns.
Assist faculty and fellows with multiple research projects.
Manage Investigator’s protocols in the Committee on Human Research online system, including renewals and modifications.
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 internal and external audits or reviews of study protocols.
Assist in preparing and monitoring study budgets.
Design and develop RedCap databases.
Enroll patients in research studies.
Perform chart reviews and data collection for later data analysis.
Work on Institutional Review Board (IRB) applications and submit protocols, regulatory documents, modifications and updates to the IRB.
Promote an environment of equity and inclusion.
Ensure IRB approval and compliance, subject recruitment, appropriate study testing, and adequate enrollment for a longitudinal cohort study.
Reconstruct the original cohort (e.g., trace past participants, complete the consenting process, schedule screenings, facilitate multiple appointments).
Prepare protocol modifications, when necessary.
Design flow sheets, data forms and source documents.
Gather and interpret medical, surgical and laboratory data regarding study participants.
Apply understanding of inclusion/exclusion eligibility criteria for protocols.
Recruit, enroll, register, schedule and retain study subjects.
Record protocol specific treatments and assure collection and shipment of samples.
Keep patients on study schedules.
Complete study forms.
Collect, enter and clean data for study databases, maintain data quality.
Assist with data analysis.
Assist with preparation of reports and tables.
Attend team meetings.
Support research projects involving early determinants of pregnancy, the effects of oxidative stress on assisted reproductive technology, and studies involving wearable technology.