Clinical Research Coordinator

Hampton University Proton Cancer Institute (Hampton Proton) is seeking a Clinical Research Coordinator to manage the daily operations, planning, implementation, and administrative lifecycle of multi-disciplinary radiation oncology clinical trials encompassing all cancer types. This role focuses on protocol compliance, data integrity, and participant safety within a complex radiation therapy environment. Key responsibilities include leading IRB submissions, managing auditing and monitoring visits, executing data query resolution, along with working alongside Clinical Trial Assistant(s) (CTAs) and Interns.

• Plan, implement, and manage complex clinical research studies in Radiation Oncology from startup through closeout.
• Coordinate patient recruitment, informed consent, trial visits, and ongoing patient participation in compliance with GCP, IRB, HIPAA, and federal regulations.
• Manage clinical trial data, including EPIC systems, EMR/medical record review, adverse event tracking, data queries, and source documentation, ensuring accuracy and completeness.
• Navigate MOSAIQ to review radiation treatment plans, dosing, fractionation, and treatment timelines for protocol compliance.
• Coordinate communication among investigators, clinical teams, sponsors, CROs, cooperative groups, and other external partners.
• Prepare, review, and maintain IRB submissions, amendments, continuing reviews, safety reports, regulatory binders, and other essential research documentation.
• Review and modify investigator-initiated protocols for scientific clarity, operational feasibility, and appropriate endpoints prior to IRB submission.
• Lead audit and monitoring activities, including sponsor visits and internal quality reviews; conduct pre-audit checks and develop CAPA plans to address findings.
• Track study milestones, accrual, deadlines, approvals, data queries, and operational deliverables; prepare monthly portfolio reports and status updates.
• Monitor patient progress, radiation toxicities, and adverse events using CTCAE criteria and ensure timely documentation and reporting.
• Collaborate with Principal Investigators, radiation oncologists, physicists, dosimetrists, and research staff to develop and execute study protocols.
• Assist with research publications, presentations, grant administration, and regulatory reporting.
• Serve as a primary patient and team resource, providing trial education, addressing concerns, and coordinating study-related activities.
• Mentor and support Clinical Trial Assistants (CTAs), delegate operational responsibilities, and maintain overall accountability for trial compliance.
• Assist with the efficient operation of workflow within the department by performing other duties as assigned.

• Strong organizational and multitasking abilities, with the demonstrated capacity to manage multiple projects and trial cohorts simultaneously.
• Excellent communication skills, both written and verbal, with the ability to collaborate effectively with clinical staff, patients, and research teams.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.
• Hands-on proficiency with EPIC and MOSAIQ is strongly preferred.
• Strong attention to detail and the ability to maintain meticulous, audit-ready records.
• Deep knowledge of Good Clinical Practice (GCP), HIPAA, and other regulatory standards related to clinical research.

• Effective written, verbal, communication, and interpersonal skills to acquire needed information and maintain cooperative working relationships with physicians and staff.
• Attention to detail and high-quality results oriented.

• Ability to…