Clinical Research Coordinator (Onsite) Hampton, VA

Hampton University Proton Cancer Institute; Hampton (VA); On-site; USD 65,000 - 90,000; Full time

Job summary

Hampton University Proton Cancer Institute is seeking a Clinical Research Coordinator to oversee daily operations and lifecycle management of radiation oncology trials. You will ensure protocol compliance, data integrity, and patient safety across multiple disciplines, coordinating IRB submissions and audits.

The role involves collaboration with investigators, sponsors, and clinical teams, with hands-on work in EPIC, MOSAIQ, and CTMS.

Qualifications

• Bachelor’s degree required; health sciences, nursing, or public health.
• CCR/CCRC certification preferred or required per site policy.
• Experience with radiation oncology trials is a plus.
• Experience with CTMS/EDC data management and regulatory compliance.

Responsibilities

• Plan, implement, and manage complex radiotherapy oncology trials from startup to closeout.
• Coordinate patient recruitment, consent, visits, and ongoing participation per GCP/IRB/HIPAA.
• Manage trial data in EPIC, EMR reviews, adverse events, data queries, and source docs.
• Review radiation plans, dosing, fractionation, and treatment timelines for protocol adherence.
• Coordinate communications among investigators, sponsors, CROs, and external partners.
• Prepare IRB submissions, amendments, continuing reviews, safety reports, and regulatory binders.
• Review investigator-initiated protocols for clarity, feasibility, and endpoints.
• Lead audits/monitoring visits, sponsor reviews, CAPA planning.
• Track milestones, accrual, deadlines, approvals, data queries, deliverables; report progress.
• Monitor patient progress and CTCAE-defined toxicities with timely reporting.
• Collaborate with PIs, radiation oncologists, physicists, dosimetrists, and staff on protocols.
• Assist with publications, grant administration, and regulatory reporting.
• Serve as primary patient and team resource; provide trial education and coordination.
• Mentor CTAs and oversee trial compliance; delegate tasks.

Skills

Organization & multitasking

Communication

MS Office

EPIC/MOSAIQ

Attention to detail

GCP/HIPAA knowledge

Education

Bachelor’s degree in Health Sciences / Nursing / Public Health

Clinical Research Certification (SOCRA CCRP or ACRP CCRC)

Tools

EPIC

MOSAIQ

CTMS

EDC platforms

Job description

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.