Join the HJF Team!
HJF is seeking a Clinical Research Coordinator to support the UCSF Pain Management Clinic located at the Naval Medical Center in San Diego, CA. HJF provides scientific, technical and programmatic support services to the Pain Management Clinic.
The incumbent will assist clinical research in conjunction with one or more specified clinical research protocols for the Pain Management Clinic at the Naval Medical Center San Diego and will be supervised by the Clinical Site Manager.
- Recruits per protocol guidelines, interviews patients for protocols to determine interest, obtains consent, and collects required data for studies based on each protocol requirement.
- Reviews new patient records and screens patients for eligibility for participating in research protocol.
- Coordinate efforts of all agencies involved in the protocol approval process. These include: Departments of Clinical Investigation, the program/study sponsor, and various other agencies.
- Manage regulatory issues for all programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs and CITI training, etc. Also, maintain accurate, regulatory-compliant program/study binders.
- Educates patients about the research protocol, their roles in the protocols, and any other vital information and acts as a research case manager for the patients where appropriate.
- Assists research team to identify problems in the research design or analysis methodology and trends in patient reactions to treatment.
- Collects, organizes, catalogs, disseminates, and maintains appropriate files of current data per HIPAA guidelines.
- Reports adverse events and protocol violations that warrant prompt action to the physicians.
- Maintains weekly/monthly status reports on all patients.
- Acts as a liaison between patients and physicians and serves as a resource for the patients.
- Facilitates communication between referring clinics/surgeons and database managers.
- Prepares and maintains manual and computerized data on patient study data and protects the data in a secure manner. Uploads enrolling data to the secure, password-protected and encrypted website.
- Transcribes and resolves queries of data in case report forms (hardcopy or electronic) and prepares documents, under direction of project heads, reporting statistical analyses and descriptive data from study results.
- Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practice.
- Assists with monitoring audits/visits for protocols.
- Travels from their assigned workplace to support protocols at other sites as needed.
- Schedules patients for appointments and visits.
- Performs other duties as needed.
Required Knowledge, Skills, and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels
Minimum Education: Bachelor's degree in a scientific discipline.
Minimum Experience/Training Requirements: 0 - 2 years of experience working with human subjects research protocols.
Physical Capabilities: Long periods of sitting and standing; some bending, lifting, and walking; escorting patients and carrying light items; may encounter patients who are confused, agitated, or abusive.
Work Environment: Laboratory, office or clinical/hospital environment.
Background/Security: U.S. citizenship required; eligible to obtain and maintain a Tier III Investigation/ Secret Clearance and Common Access Card (CAC).
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.