Clinical Research Coordination
• Handles an increased volume of studies / patients on study
• Assigned studies of increased complexity
• Independently identifies issues and proactively troubleshoots with investigators, sponsors and internal partners to ensure they are addressed.
• Analyzes problems / issues of moderately complex scope and determines solutions
• Coordinates research studies, including proactive identification of participants and supporting the PI in determining patient eligibility with limited guidance.
• Coordinate research studies, identify participants according the IRB approved recruitment plan and assist the PI with determining patient eligibility.
• Facilitate the informed consent process, communicate protocol requirements to the participant, provide participant education related to protocol requirements and the significance of protocol compliance.
• Complete, organize and maintains all documentation required by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Good Clinical Practice (GCP) Guidelines, or the funding source.
• Manages patient registration, data and treatment assignment.
• Participates in quality control and quality assurance activities related to study workflows and documentation.
• Procure and distribute required study supplies to the appropriate sites for study start-up and ongoing study needs. Including Coordination of specimen collection & shipping biospecimens.
• Facilitate the safe and accurate completion of protocol required procedures in accordance with FDA CFR, GCP, and institutional best practice.
• Collect information for adverse event (AE) or serious adverse event (SAE) reporting to review with the Investigator and facilitates reporting requirements to applicable stakeholders (DSMB, IRB, funding source).
Data & Regulatory Management
• Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable.
• Prepare and submit site or study-specific regulatory documents.
• Track and maintain required case histories/ essential documents as defined by FDA CFR and GCP to ensure regulatory compliance. Assist with routine and audits performed by internal review committees and/or external stakeholders.
• Ensure timely regulatory reporting and thorough documentation.
• Develops and implements adequate Corrective and Preventative Action (CAPA) plans as needed.
Training and Development
• Completes role-based training and occupational training as applicable, e.g. blood borne pathogens, infection control, hand hygiene, donning and doffing PPE.
• Attend study initiation meetings, and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings).
• Completes protocol required training as needed.
Service Excellence
• Provide ongoing communication to all stakeholders to ensure pertinent information is disseminated.
• Timely response to and resolution of inquiries, both written and verbal, with the appropriate level of information for the request.
• Maintain a service centered approach for both internal and external customers, ensuring a high level of quality, communication, and support.
Other Duties as Assigned
• This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change.