Clinical Research Coordinator I, Hematology/Oncology

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Organization:

Hematology/Oncology

Job Summary:

With guidance and training, is responsible for coordinating the approval processes and conduct of oncology clinical research protocols/studies in the Holowatyj Laboratory & Team, such that the integrity and quality of the clinical/translational research is maintained, the study objectives are accomplished, and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. Manages screening, implements recruitment procedures, consent, enrollment, randomization, and study conduct from planning through study closeout. Performs or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. Maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors, and other research-related entities.

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KEY RESPONSIBILITIES

• Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subjects' research and incorporates them in the conduct of research.
• Possesses a basic awareness of the Federal regulations and guidelines governing the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations), before engaging in human subjects  research.
• With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional and departmental policies and procedures and federal regulations.
• Communicates a basic knowledge and understanding of the management and implementation of clinical/translational research operations.
• Exhibits the capability to understand and follow a clinical/translational study protocol, obtaining training and seeking assistance when needed, to safely and accurately perform or assess required protocol procedures. Uses coordination skills and works collaboratively with study participants, other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures.
• Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor before, during, and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities, and others to review research, source documentation, and research procedures.
• Procures equipment and supplies needed to fulfill project requirements.
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness, and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
• Develops and maintains patient databases, investigational logs, and records of procedures followed
• Familiar with the safety reporting requirements of the study protocol, FDA, and other regulatory bodies. In a timely fashion, monitors, detects, and reports adverse events, meeting the requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes.
• Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance