Clinical Research Coordinator

MucoCept-CVN Study
UCSF is conducting an NIH-funded first-in-human phase 1 clinical trial testing safety, colonization, acceptability and clearance of a live biotherapeutic product (MucoCept-CVN) for the prevention of HIV.
MucoCept-CVN contains Lactobacillus bacteria that are naturally found in a healthy vagina and were genetically modified to Lactobacillus jensenii 1153-1666 which secretes an antiviral protein called cyanovirin designed to prevent HIV. When these bacteria live and grow in the vagina, they reproduce the built-in antiviral protein. The study is assessing the use of up to three doses of MucoCept-CVN in 12 participants.

The SF-based clinical research coordinator will perform independently and act as the primary recruiter for a clinical research study. As directed by the principal site Investigator, the clinical research coordinator will screen, enroll, and conduct all study visits. S/he will support the overall study with data management, generating reports, specimen collection and transportation, IRB requests, and coordinates the work of the nurse practitioner and study interns.

Further, the clinical research coordinator will act as intermediary between UCSF and the study sponsor DAIDS,
coordinate staff work schedules, assist with training of interns, help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; maintain all regulatory documents; report study progress to investigators; and perform other duties as assigned.

This position is in the Department of Obstetrics, Gynecology, & Reproductive Sciences (ObGyn & RS), a major
academic department in the School of Medicine committed to providing quality health care services, educating
health care providers and investigators, and conducting research to advance knowledge in our field. The
Department is nationally recognized for research and training in women's health care specialties. This position is based at the Department's San Francisco General Hospital (SFGH) Division, a large teaching, research, and clinical site. The SFGH Division of Ob-Gyn & RS is home to ~40 faculty, 8 non-faculty academics, and 110 staff; fellows, residents, and other trainees; and the Bixby Center for Global Reproductive Health. The SFGH division has an annual budget of over $70M. Our mission in the SFGH Division of Ob-Gyn & RS is to promote justice, quality, and equity in women's health care. We seek to eliminate barriers to good health for women in San Francisco and around the world. We are committed to building and supporting a diverse and inclusive workplace and strive to understand and address the impact of structural inequities on sexual and reproductive health.

This position is an integral part of the Bixby Center for Global Reproductive Health which is situated within the
ZSFG Division of Ob-Gyn & RS. The Bixby Center leads research and training programs around the world to
improve reproductive and sexual health. We work to ensure that all people have access to birth control, abortion, sex education, pregnancy and birth care and HIV/STI treatment-regardless of their age, ethnicity, income, or where they live. Our 200+ members advance reproductive health policy and practice worldwide through research, training and advocacy. Since the Bixby Center's founding in 1999, our research has changed policy, clinical care and laws for the better. Our work informs evidence-based reproductive and sexual health policies, treatment and care guidelines to save women's lives around the world.

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)
40% 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.
15%
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 PI.
* Maintain data collection forms for effective data collection, entry, and analysis.
* Perform queries and analysis in databases.
* Work with the data management organization DFnet to maintain complete and
accurate data in the study database; analyze the data as they become available.
20%
YES Staff Training, Study Implementation and 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
* 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
* 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
10%
YES
Specimen Management/ Maintenance
* 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.
10%
YES
Regulatory responsibilities and Quality Assurance
* 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.
* Enter all existing and new study protocols into the 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.
5% Yes Promotes an environment of equity and inclusion with 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. Undertake activities that align with extramurally funded
clinical trial work.
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:

• Excellent attention to detail; highly organized and efficient; strong interpersonal skills; excellent, effective verbal, over-the-phone 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.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Possess technical knowledge in the areas of health research, regulatory and ethical review board
  guidelines, interview administration.
• Good understanding of the health context in which study takes place
• Advanced knowledge of Microsoft Office, including word, powerpoint, excel; familiarity with Access
  
  

Preferred Qualifications:

• Bachelor's Degree strongly preferred
• MPH or other degree in health sciences preferred
• Fluency in the usage of the 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.
• Experience with recruitment via websites, electronic community board postings, etc.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, procurements, 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

Required Qualifications:

• Excellent attention to detail; highly organized and efficient; strong interpersonal skills; excellent, effective verbal, over-the-phone 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.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Possess technical knowledge in the areas of health research, regulatory and ethical review board
  guidelines, interview administration.
• Good understanding of the health context in which study takes place
• Advanced knowledge of Microsoft Office, including word, powerpoint, excel; familiarity with Access
  
  

Preferred Qualifications:

• Bachelor's Degree strongly preferred
• MPH or other degree in health sciences preferred
• Fluency in the usage of the 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.
• Experience with recruitment via websites, electronic community board postings, etc.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, procurements, 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