UNIV - Research Study Coordinator - Hollings Cancer Center

Medical University of South Carolina•Charleston, SC

1d•$46,206 - $78,540

About The Position

Under general supervision of the Clinical Trials Office and the disease group Program Manager within the Clinical Operations Unit, the Research Study Coordinator coordinates, establishes, and supervises complex oncology research protocols at Hollings Cancer Center. The role supports the integration of National Cancer Institute, investigator-initiated, and industry-sponsored trials at the Medical University of South Carolina. The coordinator promotes awareness of the clinical trial program and uses judgment in managing study participants. The position coordinates participant care and protocol compliance, screens patients for clinical trials, supports informed consent and enrollment, and collects and submits accurate research data. It also manages reporting of adverse events and other reportable events, maintains knowledge of disease-specific trial portfolios, and supports trial start-up, protocol amendments, and program development. The role may support research activities at the MUSC main campus and Hollings Cancer Center satellite locations.

Requirements

Bachelor's degree.
Two years of relevant program experience.
Knowledge of oncology and medical terminology, disease-specific staging, and clinical trial eligibility criteria, as needed to screen patient records effectively.
Ability to coordinate complex oncology research protocols and manage participant status and study documentation accurately and within required timelines.
Ability to handle bloodborne pathogens and human specimens in accordance with OSHA guidelines.

Responsibilities

Coordinate participant research activities to meet protocol requirements, maintain protocol compliance, and keep participant status current in the clinical trials database, CTMS, and EPIC within required timelines.
Provide protocol-specific information to physicians, nurses, patients, and other care-team members; coordinate eligibility workups, treatment plans, follow-up, and protocol-related visits.
Coordinate study-related sample preparation, handling, and shipment, including handling bloodborne pathogens and human specimens in accordance with OSHA guidelines.
Consult with investigators and clinical staff to assess participant response to therapy, toxicities, and disease status.
Screen newly diagnosed, progressed, or recurrent HCC patients for potential clinical trial participation; document and track screening efforts and communicate with investigators and care teams about potential participants.
Assist investigators with identifying, consenting, screening, registering, and enrolling eligible patients, and support informed consent in accordance with departmental and institutional policies.
Attend and participate in multidisciplinary tumor boards, clinics, conferences, disease focus group meetings, and weekly clinical operations team meetings; plan clinic coverage as needed.
Collect, prepare, and submit accurate and timely research data, case report forms, queries, questionnaires, imaging materials, and other study documentation to research databases and sponsors.
Maintain source documentation and coordinate with Data Coordinators on protocol visits, adverse event logs, questionnaires, specimens, and study supplies.
Submit adverse events, serious adverse events, protocol deviations, and other reportable events to the NCI, sponsors, IRB, and DSMC within applicable requirements; prepare required initial and follow-up reports.
Submit regulatory documents to the Manager of Regulatory Compliance and complete screening logs and database updates; address outstanding sponsor monitoring items within required timelines.
Maintain working knowledge of disease-specific trial portfolios and support trial start-up, protocol amendments, roadmaps, study credentialing, and accurate documentation of study assessments and treatment parameters.
Present research data and protocols to focus groups and investigators, assess patient populations and trial feasibility, support program expansion and new projects, and organize meetings and agendas.