Clinical Research Coordinator (Onsite) Hampton, VA
About The Position
Hampton University Proton Cancer Institute (Hampton Proton) is seeking a Clinical Research Coordinator to manage the daily operations, planning, implementation, and administrative lifecycle of multidisciplinary radiation oncology clinical trials encompassing all cancer types. The role focuses on protocol compliance, data integrity, and participant safety in a complex radiation therapy environment. The coordinator leads IRB submissions, manages auditing and monitoring visits, resolves data queries, and works with Clinical Trial Assistants (CTAs) and interns. The position is full-time and onsite in Hampton, Virginia. It involves coordinating trial activities from startup through closeout, maintaining regulatory and study documentation, monitoring participant safety and treatment compliance, and collaborating with investigators, clinical teams, sponsors, and external partners. The coordinator also mentors CTAs and supports research publications, presentations, grant administration, and regulatory reporting. Hampton Proton is a proton therapy treatment and research center that has treated a variety of cancers since August 2010. The posting describes the facility as having four gantry rooms and one fixed beam room.
Requirements
- Bachelor’s degree in Health Sciences, Nursing, or Public Health.
- Certification in Clinical Research, such as SOCRA CCRP or ACRP CCRC.
- Minimum of 2–3 years of experience in a clinical or research setting, preferably in oncology or radiation oncology.
- Proven experience managing clinical trials, including direct patient recruitment, data collection, and regulatory compliance.
- Strong organizational and multitasking abilities, including the ability to manage multiple projects and trial cohorts simultaneously.
- Excellent written and verbal communication skills and the ability to collaborate with clinical staff, patients, and research teams.
- Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint, and familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.
- Strong attention to detail and ability to maintain meticulous, audit-ready records.
- Deep knowledge of Good Clinical Practice (GCP), HIPAA, and other regulatory standards related to clinical research.
- Ability to acquire needed information and maintain cooperative working relationships with physicians and staff.
- Ability to prioritize multiple needs and meet deadlines.
Nice To Haves
- Hands-on proficiency with EPIC and MOSAIQ is strongly preferred.
- Familiarity with radiation oncology terminology, procedures, and technologies, such as dosing schedules, fractions, and linear accelerators, is highly desirable.
- Experience in oncology or radiation oncology is preferred.
Responsibilities
- Plan, implement, and manage complex radiation oncology clinical research studies from startup through closeout.
- Coordinate patient recruitment, informed consent, trial visits, and continued participation in compliance with GCP, IRB, HIPAA, and federal regulations.
- Manage clinical trial data, including EPIC systems, medical record review, adverse event tracking, data queries, and source documentation, ensuring accuracy and completeness.
- Use 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 before 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 by providing trial education, addressing concerns, and coordinating study-related activities.
- Mentor and train Clinical Trial Assistants (CTAs), delegate operational responsibilities, and maintain overall accountability for trial compliance.
- Assist with efficient departmental workflow and perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
