Clinical Research Coordinator

The Sobhani Research Group (PI: Nasim Sobhani) is dedicated to improving the care of pregnant individual and their infants. The bulk of our studies are focused on diabetes in pregnancy and how to optimize the care of pregnant people living with diabetes. Our studies examine how to improve perinatal outcomes for pregnant individuals with type 1 and type 2 diabetes; leverage advanced diabetes technology in the pregnant population; diagnose and manage gestational diabetes; and better support the emotional and behavioral needs of pregnant individuals with diabetes.

The Clinical Research Coordinator 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.

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, including ensuring complete and accurate data capture; attend regular meetings with the PI and/or other members of the study team; 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 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; support the development and submission of publications, presentations, reports, and other study-related documents; and perform other duties as assigned.

The CRC will assist the Sobhani Research Group with multiple projects. The CRC will design and develop RedCap databases, enroll patients in research studies and complete chart reviews, data collection and data for later data analysis. The CRC will also perform and/or coordinate biospecimen collection with study participants, coordinate with research team staff, perform initial sample processing and stabilization, and ensure transfer of the specimens to partnering research labs as needed. The CRC will work on IRB/CHR applications and submit protocols, regulatory documents, modifications and updates to the CHR for various ongoing studies. The CRC will coordinate with our multidisciplinary team and collaborators across departments within UCSF as well as non-UCSF campuses. This includes outreach and communication with referring healthcare providers and patient support organizations. 

A successful candidate will have a desire to work directly with patients; be passionate about supporting research studies that aim to improve our understanding of pregnancy complications; be dedicated to optimizing the care of individuals with medically complex pregnancies; be committed to the development of evidence-based practices. They will be an independent problem-solver with excellent communication, interpersonal, and organizational skills. They will have a high level of professionalism, an exceptional attention to detail, and experience managing multiple projects and timelines simultaneously. This is a great opportunity for an individual who is interested in academic research, medicine, health care, or public health. A two-year commitment is preferred.

DEPARTMENT INFO:

The Department of Obstetrics, Gynecology and Reproductive Sciences (Ob, Gyn & RS) is a major academic Department in the School of Medicine, engaged in clinical, research and training activities at the Parnassus, Mount Zion, and Zuckerberg San Francisco General Hospital campuses, the new Betty Irene Moore Women’s Hospital at Mission Bay, as well as satellite locations throughout the Bay Area, with an annual operating budget of $150 million. The Department has 134 full-time faculty, 117 other academic appointees, 13 post-doctoral fellows, 22 clinical fellows, 32 residents, 138 voluntary clinical faculty and 270 staff.

The mission of the Department of Obstetrics, Gynecology & Reproductive Sciences is to improve the lives and health of all women through excellence, innovation and leadership in patient care, scientific discovery, education, advocacy, and diversity, equity and inclusion. We are committed to providing quality health care services; educating health care providers and investigators; and conducting research to advance knowledge in our field.

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

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

20

YES

Study Coordination and Data Collection

• 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.
• 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.
• Perform (if certified) and/or coordinate biospecimen collection
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.

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.

5

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.

5

YES

25

YES

Study Implementation

5

YES

Specimen Management/ Maintenance

10

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.

10

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%

REQUIRED:

• 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.

• Reliable, self-motivated, and able to prioritize tasks and meet deadlines 

• Excellent written, oral, and interpersonal communication skills

• Capable of discussing personal topics with patients in a compassionate, sensitive manner

• Experience with electronic medical records.
• Experience with REDCap 

PREFERRED:

• Fluency in the Spanish language 
• ≥ 2 years of full-time work experience in a related field
• Experience caring for and/or interacting with individuals living with diabetes
• Proficiency in the usage of Committee of Human Research (CHR) online 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.
• 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

CHR regulations for recruitment and consent of research subjects

Effective Cash Handling Procedures

Environmental Health and Safety Training 

Fire Safety Training