Clinical Research Coordinator HEMONC

The Clinical Research Coordinator (CRC) will work with a close-knit group of health services researchers and clinicians at the University of California, San Francisco and San Francisco VA Health Care System, who are focused on improving the health of older persons. We are looking for a highly motivated candidate with a strong work ethic who has a background in clinical research or a related field, to assist the Principal Investigator (PI) on a study related to health services. The 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 Clinical Research Supervisor and/or Principal Investigator (PI); coordinate the data collection and operations of clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

The CRC's duties may include, but will not be limited to: recruiting research subjects (identification, determine eligibility and obtain consent of potential research participants); obtaining medical and health information from participants and abstracting information from electronic clinical records; administering surveys; conducting semi-structured interviews; overseeing participant payments; creating, cleaning, updating, and managing qualitative and quantitative datasets and reports; analyzing data using quantitative and qualitative methods; assisting in conducting literature reviews; participate in manuscript preparation and research result presentation. Administrative duties may include: coordinating project schedules and team meetings; managing 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; participating in the review and writing of protocols to ensure institutional review board approval within University compliance; helping assure compliance with all relevant regulatory agencies; overseeing study data integrity; implementing and maintaining periodic quality control procedures; maintaining all regulatory documents; participating in any internal and external audits or reviews of study protocols; and performing other research-related duties as assigned.

Responsibilities

of time ( Nothing less than 5%)

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.
• Maintain lists of study participants and tracking systems for each project.
• 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.
• Work with PIs and other staff to ensure procedures and data reports are completed, required data collected at visits or pulled from reports; and maintaining data safety.
• Track relevant study milestones to ensure the team is on time in providing necessary deliverables to funders.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Suggest modifications to accommodate increasing complexity of studies.

30%

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.
• Prepares, edits and modifies documents including research reports, manuscripts, presentations and proposals, including assisting with manuscript and grant writing.
• 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
• Assist PI and biostatisticians with analysis of data and preparation of results

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
• Complete all Annual Training review programs and identify need for study team education.
• Participate in relevant research-related meetings and trainings at UCSF and SFVA.
• 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
Quality control procedures
5%

YES
Study Implementation
0
YES
Specimen Management/ Maintenance

5%

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.

5%

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.

5%

Communication and Collaboration Responsibilities

• Communicate program, operational, and administrative information to stakeholders through clear written and verbal communication.
• Organize and present information, facilitate informed decision-making.
• Respond to inquiries, provide clarification, and follow up to ensure issues are addressed and resolved.
• Coordinate and collaborate with internal and external partners to support program and operational needs.
• Adjust communication methods and workflows to align with changing organizational priorities and systems.

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%.)

Qualifications

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.

Preferred Qualifications

• Undergraduate degree or Master's degree in the health sciences, or related field
• Qualitative research experience including but not limited to conducting interview and focus groups and analyzing qualitative data
• Experience in active listening, empathetic interviewing
• Experience with REDCap, Qualtrics or some other database/survey platforms
• Experience conducting reviews of electronic medical records.
• Makes sound decisions under pressure and has strong ability to assess when to escalate matters to a superior.
• Completes projects in a timely manner, and prioritizes multiple projects to ensure the completion of essential tasks by deadlines.
• Understanding of medical terminology.
• Ability to create rapport and relationships with diverse patient populations, while also giving insight to what is realistic and appropriate for patient participation.
• Knowledge of medical terminology, research policies and guidelines
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
• 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.)
• Experience applying the following regulations and guidelines:
  o Good Clinical Practice Guidelines
  o Health Information and Accountability Act (HIPAA)
  o The Protection of Human Research Subjects
  o CHR regulations for recruitment and consent of research subjects
  o Effective Cash Handling Procedures
  o Environmental Health and Safety Training
  o Fire Safety Training
• Prior experience with research in the clinical or social sciences, including prior academic research experience, e.g. college-level research; sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Strong work ethic.
• Strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions.
• Ability to express facts and ideas in writing in a succinct and organized manner.
• Ability to collaborate effectively as part of a team, multi-task in a fast-paced environment while working with a diverse subject population.
• Demonstrates and promotes professional and personal integrity.
• Proficiency in MS Suite (Outlook, Word, Excel, PowerPoint, Office 365/MS Teams, etc.) and videoconferencing (Zoom, Teams, etc.)

About Us

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: