Study Coordinator II

Overview

The Study Coordinator II provides advanced coordination and operational support for government‑led clinical and translational research studies. Working under the direction of the Principal Investigator (PI) and/or designated government point of contact (POC), this position is responsible for the day‑to‑day execution of study activities, including subject screening, enrollment, and monitoring; collection and management of clinical and research data; and coordination of biospecimen collection for laboratory analysis.

The Study Coordinator II ensures that all study procedures are conducted in accordance with approved protocols, regulatory and ethical requirements, and institutional policies, and contributes to data analysis and the preparation of written reports and summaries of study findings.

This position aligns with Cayuse’s core values of Innovation, Excellence, Collaboration, Adaptability, and Integrity by fostering technical solutions that meet customer needs, promoting teamwork, and prioritizing quality in deliverables.

• Identify potential clinical and translational research studies and assess the suitability of the TAMC patient population based on protocol‑specified inclusion and exclusion criteria, anticipated enrollment needs, and required timelines for study completion.

• Align sponsored studies with an appropriate Principal Investigator (PI), taking into account clinical specialty, research interests, and operational feasibility, and coordinate initial study start‑up discussions as needed.

• Advise and support the PI with respect to Scientific Review Committee and Institutional Review Board (IRB) requirements, including preparation and submission of protocol materials, amendments, and continuing reviews, and coordinate interactions with clinical collaborators, sponsors, and other external partners.

• Recommend, help assemble, and coordinate clinical and translational study teams—including study coordinators and other required personnel—to support effective execution, monitoring, and close‑out of assigned studies.

• Collect, organize, maintain, and securely manage study data and documentation; administer day‑to‑day project activities; and assist with drafting reports, abstracts, and manuscripts derived from study findings.

• Review patient records to identify and pre‑screen potentially eligible subjects, provide input on enrollment strategies, and coordinate or perform study subject enrollment activities, including collection of required clinical specimens for laboratory analysis in accordance with protocol requirements.

• Collaborate with internal departments across TAMC (e.g., Pharmacy, Laboratory, Radiology, Nursing) to support implementation of clinical and translational studies. For prospective clinical trials, oversee or coordinate the informed consent process, monitor and document patient response to therapy, and ensure that all adverse events and protocol deviations are promptly noted, cataloged, and reported per regulatory and sponsor requirements. For translational laboratory or animal model studies, coordinate and perform specimen collection, processing, and documentation.

• Track study subject course and status throughout participation; interface regularly with physicians, nurses, and technicians to obtain current clinical information; and ensure that all case report forms and other required study documentation are completed accurately, contemporaneously, and in accordance with sponsor and regulatory requirements.

• Retrieve relevant data from patients’ written and electronic medical records and other institutional systems (e.g., imaging, laboratory, and culture result databases), abstract necessary information, and accurately enter these data into case report forms, databases, or electronic data capture systems.

• Maintain strict confidentiality and secure handling of all study logs, source documents, and collected patient data in accordance with HIPAA, institutional policies, and protocol‑specific confidentiality requirements.

• Prepare written analytic reports that summarize study data, including a description of statistical methods used, evaluation of statistical…