Clinical Research Coordinator

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Clinical Research Coordinator

Location(s): San Francisco, CA
(4 days onsite)

Job Overview:
Incumbent will provide clinical research coordination for a variety of health policy, observational, and clinical outcomes studies as assigned. The CRC will be responsible for recruiting study participants through screening in person, via Epic, and by phone. The CRC will collect data as required by study protocols from the enrolled participants. The CRC will assist with IRB submission and other regulatory documentation maintenance needed for each study supported.
The incumbent will work under the direction of their supervisor in support of Department PI. The selected individual will play a critical role in coordinating aspects of clinical research daily operations on assigned studies within the Department of Orthopaedic Surgery. The Clinical Research Coordinator (CRC) will ensure successful implementation of and adherence to clinical research protocols regarding planning, administration, participant confidentiality, timeline management enrollment, participant engagement, data/sample collection, and reporting.

The CRC will demonstrate competence in clinical research skills, problem solving, priority-setting and serve as a resource for others in the department for all aspects of conducting a clinical trial. This requires close interaction with patient care staff, research team members and study personnel at other sites. Study duties include the coordination of research protocols, including coordination of the data/specimen collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

This includes but is not limited to collecting and reporting on study results; create, clean, update, and manage databases and comprehensive datasets and reports; and coordinate project workflow with research team members. Critical duties include preparation, coordination and/or maintenance of regulatory documentation in the CHR system as well as all other reporting / compliance requirements.

Key Responsibilities:
Study Coordination:

• Responsible for coordinating multiple clinical research studies simultaneously including multicenter clinical trials, NIH and industry-sponsored studies, and local investigator-initiated clinical trials.
• Identify subjects, develop recruitment and retention strategies, obtain informed consent, screen and enroll study subjects.
• Schedule subjects for study visits and/or coordinate the scheduling of required laboratory tests and/or exams; meet with participants to administer questionnaires, collect medical history and perform study procedures according to the study protocol.
• Monitor participants for evidence of study related adverse events.
• Document adverse events and protocol deviations and submit to appropriate departments.
• Document study participants’ progress in electronic medical record and study records as per protocol.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Maintain subject data and address study specific data queries promptly.
• 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.
• 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.
• Develop and maintain required documentation for clinical trials.
• Reconciliation of subject encounters with billing to ensure correct billing practices and avoid improper billing of Medicare, private insurance, or patients.
• Assure studies are carried out in accordance with all relevant regulations including Code of Federal Regulations, Good Clinical Practice, UCSF regulations, and in accordance with Departmental SOPs.
• Assist in the development of databases and participant trackers needed to capture specific protocol required data.
• Remain up to date on all required trainings (E.g., UCSF trainings, Departmental trainings, study specific trainings, etc.)
• Serve as a resource for investigators and clinical research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
• Ensures proper collection, processing, storage, transport, and handling of biological specimens.
• 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…