Clinical Research Coordinator (Onsite) Hampton, VA

CLINICAL RESEARCH COORDINATOR (FULL-TIME ONSITE) HAMPTON, VA

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 Clinical Trial Assistants (CTAs) and Interns.

Duties and Responsibilities:

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 train 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.

Qualifications:

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 multi-task and prioritize needs in order to meet deadlines.

Requirements:

Bachelor’s degree in Health Sciences, Nursing, or Public Health.
Certification in Clinical Research (e.g., 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
Familiarity with radiation oncology, terminology, procedures, and technologies (e.g., dosing schedules, fractions, linear accelerators) is highly desirable.

Physical Demands:

Work environment is onsite in an office setting.
Extended periods of time in a sitting/stationary position.
Constantly operates office technology, such as computers and printers.
Be able to reach, push, pull, hold, and lift up to 25 lbs., as needed.
Occasional standing or walking through the radiation oncology clinic to meet with patients or investigators is required.
Frequently communicate through listening and speaking to exchange accurate information.

The pay range reflects the current compensation range for this position at the time of posting. Individual offers are determined based on directly related experience, skills, education, internal equity, and other job-related factors. Not all candidates will qualify for the upper end of the posted range.