Clinical Research Coordinator - Surgery

UCSF•San Francisco, CA

18h•$40 - $65

About The Position

The Clinical Research Coordinator (CRC) independently or with general direction executes, manages, and coordinates clinical research protocols at the fully operational journey level. Under the direction of the Clinical Research Supervisor and/or Principal Investigator (PI), the CRC may coordinate data collection and operations for several concurrent studies in accordance with research protocols and UCSF and regulatory agency policies. The position supports study coordination, subject recruitment and retention, informed consent, study visits and procedures, data and specimen management, database development and maintenance, reporting, staff coordination and training, quality control, protocol submissions, regulatory compliance, and audit preparation. The CRC also serves as an intermediary among subjects, investigators, departments, and collaborating groups, and performs other duties as assigned. The role is within the UCSF Department of Surgery, whose mission includes developing future surgical leaders, providing compassionate and cost-effective clinical care, and advancing scientific knowledge and clinical practice through research. The Department includes seven divisions. The Division of Transplant, which includes Liver, Kidney, and Pancreas Services, focuses on coordinating high-quality care for patients with end-stage organ disease and/or undergoing transplantation.

Requirements

High school diploma or equivalent experience/training.
Attention to detail and strong interpersonal skills.
Excellent and effective verbal and written communication skills.
Ability to multitask in a fast-paced environment while working with a diverse subject population.
Ability to coordinate with subjects, team members, other departments, and outside institutions.
Ability to work independently, complete projects in a timely manner, and prioritize multiple projects to meet deadlines.

Nice To Haves

Fluency with the Committee on Human Research (CHR) online iMEDris system for protocol submission, renewal, and modification.
Understanding of the patient population and ability to build rapport and assess realistic and appropriate participation.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
Bachelor of Science degree.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies on reimbursement, research, confidentiality, HIPAA, patient safety, and research purpose; knowledge of medical terminology, research policies and guidelines, infectious-substance packing and shipping, database development and analysis, and data management using tools such as Access, Stata, SAS/SPSS, and Teleform.
Experience applying Good Clinical Practice Guidelines, HIPAA, protections for human research subjects, CHR recruitment and consent regulations, effective cash-handling procedures, Environmental Health and Safety training, and Fire Safety training.

Responsibilities

Identify, recruit, screen, enroll, and retain study subjects; develop recruitment and retention strategies.
Schedule study visits; administer questionnaires, collect medical histories, and perform study procedures.
Build relationships with subjects, address their needs, coordinate follow-up, and act as an intermediary; discuss study outcomes with providers to support continuity of care.
Obtain informed consent, review study information with subjects, and advocate for patient safety during protocol procedures.
Oversee subject reimbursement and help resolve discrepancies.
Coordinate study procedures, specimen storage, data collection, shipping, and labeling with staff and affiliated groups.
Review medical charts and electronic records to extract study data.
Recommend improvements to patient coordination, data collection and management, protocol adherence, and study collaboration.
Collect and enter data from visits, procedures, laboratory tests, and other study participation into databases in a timely manner.
Manage and improve protocol databases; create databases and comprehensive datasets as needed, maintain data collection forms, run database queries and analyses, and work with the Supervisor to ensure data completeness and accuracy.
Train staff and others on protocols, procedure changes, data collection and entry, database procedures, chart review, and related processes; participate in team meetings.
Oversee data integrity, assess recruitment and data-management procedures, maintain procedure manuals, and develop plans for consistent data collection and entry.
Implement and maintain quality-control procedures; recommend administrative changes to support increasingly complex studies and modify data-collection instruments.
Help schedule and coordinate staff; maintain subject tracking systems.
Coordinate specimen exchange and transport; oversee interpretation and appropriate use of incoming sample data and maintain specimen integrity and security.
Enter existing and new protocols into the Committee on Human Research (CHR) online system; coordinate with CHR Analysts as needed.
Design and improve case report and data-collection forms, provide manuscript feedback, and maintain systems for protocol adherence and data quality.
Participate in reviewing and writing protocols and related procedures to support institutional review board approval and University compliance.
Renew, modify, and submit CHR applications and protocols in a timely manner; track approvals and liaise between CHR and study investigators.
Conduct ongoing protocol quality-assurance checks and implement improvements or modifications as needed.
Ensure studies comply with the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Obtain departmental UCSF approvals before study initiation; maintain regulatory documents, monitor submission timelines, and document and report adverse events to appropriate departments.
Maintain patient confidentiality when communicating with agencies, providers, studies, and outside departments.
Participate in and cooperate with internal and external audits or protocol reviews and prepare required documentation.
Perform other duties as assigned.