Clinical Research Coordinator

UCSF•San Francisco, CA

14d•$40 - $47•Onsite

About The Position

The Clinical Research Coordinator (CRC) performs independently or with general direction at the fully operational journey level to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI). The CRC may coordinate data collection and operations for several concurrent clinical research studies under research protocol guidelines and UCSF and regulatory agency policies. The CRC assists neurologists and other members of the clinical and research team in the Movement Disorders and Neuromodulation division with clinical research studies and clinical care, including drug treatments and observational studies for patients with Parkinson’s disease and other movement disorders. The role involves frequent interactions with patients; coordinating and attending complex clinic and study visits; collecting research data; managing databases, case report forms, supplies, and regulatory documents; and collecting, processing, and shipping biological specimens. The CRC supports single or multiple studies, depending on their size and complexity. The position also involves coordinating services and departments; managing and reporting study results; creating, cleaning, updating, and maintaining databases, comprehensive datasets, and reports; coordinating staff schedules and assisting with staff training; managing study protocols and submissions through the Committee on Human Research (CHR) system; contributing to protocol review and writing; ensuring institutional review board approval and regulatory compliance; overseeing data integrity and quality control; obtaining UCSF approvals before study initiation; reporting progress to investigators; and participating in audits and reviews. Other duties may be assigned.

Requirements

High school graduation and experience in clinical research coordination, clinical research operations, or a related research environment involving human subjects.
Attention to detail and strong interpersonal, verbal communication, and written communication skills.
Ability to coordinate with subjects, team members, other departments, and outside institutions, and to work with a diverse subject population.
Ability to multitask in a fast-paced environment, work independently, complete projects on time, and prioritize competing projects and deadlines.
Knowledge of clinical research regulations and guidelines, including Good Clinical Practice (GCP), Human Subjects Protection regulations, HIPAA, and IRB processes and compliance requirements.
Experience coordinating clinical research studies, including participant recruitment, informed consent, study visit coordination, and protocol implementation.
Experience collecting, documenting, and managing research data, including completing and maintaining case report forms and accurate study records.
Ability to accurately execute clinical research protocols in a timely manner and coordinate multiple concurrent studies while maintaining protocol compliance.
Experience working directly with research participants or patients, including scheduling visits, coordinating procedures, and maintaining professional communication.
Experience collecting, processing, and coordinating shipment of biological specimens in accordance with study protocols and safety regulations.
Strong organizational, analytical, and problem-solving skills, including the ability to manage detailed documentation and maintain data integrity.
Ability to collaborate with investigators, clinicians, research staff, and external partners.
Proficiency with Microsoft Office software, including Word and Excel.
Interest and ability to work with participants in a clinical research setting.
Ability to work onsite depending on project needs.
Proficiency with standard computer applications and research documentation tools, including electronic medical records and database systems.

Responsibilities

Identify potential subjects; develop recruitment and retention strategies; screen and enroll study subjects.
Schedule study visits; administer questionnaires; collect medical histories; and perform study procedures.
Maintain relationships with study subjects, support communication and retention, coordinate follow-up appointments, and serve as an intermediary for participant needs.
Discuss study outcomes with providers to support continuity of care.
Obtain informed consent, review study information with subjects, and advocate for participant safety during protocol procedures.
Oversee subject reimbursement and resolve related discrepancies or issues.
Coordinate staff to ensure study procedures are completed, specimens are stored correctly, data are collected, and shipments are correctly labeled and handled.
Coordinate schedules and communications with other studies, technicians, affiliated groups, and collaborating staff.
Review medical charts and electronic records to extract information for studies.
Assess and 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 update protocol databases, create databases as needed, maintain comprehensive datasets and data collection forms, and perform database queries and analyses.
Work with the supervisor to maintain accurate study data and analyze data as it becomes available.
Help train staff on protocols, procedural changes, data collection and entry, database procedures, chart review, and related processes; participate in team meetings.
Oversee data integrity and assess policies and procedures for recruitment, data collection, and data management.
Maintain procedure manuals and subject tracking systems; help develop plans for consistent data collection and entry; implement quality control procedures; and modify data collection instruments as needed.
Help schedule staff time and coordinate staff schedules.
Arrange specimen exchange and transport, oversee incoming sample data used for analyses and publications, and ensure sample integrity and security.
Enter new and existing protocols into the CHR online system; coordinate with CHR analysts; renew, modify, and submit CHR applications and protocols; and track approval status.
Design and improve case report forms 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.
Assure studies comply with the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Obtain UCSF approvals before study initiation; maintain regulatory documents; monitor data-submission timelines; and document and report adverse events to appropriate departments.
Protect patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
Participate in and cooperate with internal and external audits or reviews of study protocols, and prepare necessary documentation.
Perform other duties as assigned.