Clinical Research Coordinator

Please note: This role is 3 days on-site and cover letter required.

Location:

WGV-CV Academic Tower

490 Illinois Street, Floor 10

San Francisco, CA 94143

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.

%

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, 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.
• Manage and execute on the translation of consent documents and other study materials if demonstrated proficiency is proven in either the Spanish or Mandarin language.
• 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 efficiencyin 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.
• Research and justify purchases, study materials, and supplies; establish research contracts with potential sponsoring companies.
• 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.
• Send weekly updates of study recruitment stages, enrollment and pending inquiries to study team.
• Create and update study materials (website, flyers, handouts, videos) as necessary for recruitment.
• 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.
• Track recruitment material feedback/usage and adjust accordingly, such as Google Analytics.

10%

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.
• Read the scientific articles supporting your study as provided in the study submission and share up-to-date findings and protocols as researched.
• 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.
• Process samples as necessary according to the existing protocol and procedures.

10%

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.
• Assist in entering the study protocol into the OnCore online system for budgetary review.

5%

YES

Staff training

• Help train staff and others on the DESCRT study; changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
• Hold training and review sessions for nursing and sonogram staff on study procedures
• Attend and actively participate in regular team meetings. Create presentations for each meeting outlining study recruitment, enrollment, results & other pertinent information. Maintain meeting minutes and send out to study team following the meeting with duties for each member.

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.

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.
• Comfortable working in a reproductive clinic setting and interacting with both male and female patients regarding reproductive activities, procedures and the collection of biological samples.
• Schedule flexibility and availability on weeknights and weekends for patient recruitment events & availability for participants

Preferred Qualifications:

• 3-5 years of full-time work experience in a related field.
• 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

• Proficiency in Spanish or Mandarin language.

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here.

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

To learn more about the benefits of working at UCSF, including total compensation, please visit:

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.
• Comfortable working in a reproductive clinic setting and interacting with both male and female patients regarding reproductive activities, procedures and the collection of biological samples.
• Schedule flexibility and availability on weeknights and weekends for patient recruitment events & availability for participants

Preferred Qualifications:

• 3-5 years of full-time work experience in a related field.
• 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

• Proficiency in Spanish or Mandarin language.