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Clinical Research Coordinator

2 months ago

Washington, United States INTELLECTT INC Full time

The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel, and direct the work of a Clinical Research Assistant as assigned.

Minimum Education

Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field, or other applicable discipline (Required)

Minimum Work Experience

1 year of applicable work, research, or internship experience (e.g. research assistant, data manager, clinician, or other interaction with a research population) (Required)

Functional Accountabilities

Responsible Conduct of Research

Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts, and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Council on Harmonization) regarding human subjects research and the use of protected health information. Uses research funds and resources appropriately. Maintains the confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration

Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines, and eligibility. Accurately creates, completes, maintains, and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational products, and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to the clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by the principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies, and the Clinical Research Center. Participant Enrollment

Employs strategies to recruit and retain research participants while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, conducts, and documents visits and protocol-specific testing/interviews according to the study protocol, operational plans of clinical departments, and SOPs for minimal risk studies or for other studies under direction. Interacts with study participants and/or legally authorized representatives (LARs) to communicate the study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documentation of study payments and participation incentives. Study Management

Plans, conducts, and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures the regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB, and other oversight bodies in accordance with federal regulations, sponsor SOPs, and institutional policies. Collects, prepares, processes, ships, and maintains an accurate inventory of research specimens and trains others in performing these tasks. Suggests improvements to specimen handling processes when needed. Authors study documents, including informed consents, protocol-specific source documents, and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for, and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection

Collects data from patient medical records, interviews, questionnaires, diagnostic tests, and other sources. Ensures data is collected as required by the protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling, and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents.

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