Clinical Research Coordinator

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

Clinical Research Coordinator (CRC) to provide specialized scientific and clinical research support to the Defense Health Agency (DHA) Clinical Investigation Program at Naval Medical Center Portsmouth (NMCP). The CRC will independently coordinate assigned clinical and biomedical research activities supporting the Clinical Investigation Department (CID), Combat Trauma Research Group (CTRG), Graduate Medical Education (GME) Program, and other NMCP clinical departments. The position requires advanced knowledge in biological sciences, health sciences, physiology, or a closely related scientific discipline, acquired through specialized academic education and applied to the coordination, evaluation, and execution of complex research protocols. The CRC will exercise independent professional judgment in assessing research activities, evaluating scientific and regulatory information, identifying protocol compliance risks, resolving research coordination issues, and recommending scientifically appropriate corrective actions. The CRC will collaborate with Government Principal Investigators (PIs), research scientists, medical personnel, and institutional research oversight bodies to support the successful execution of Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC)-approved research.

Responsibilities

Essential Job Functions:

• Scientific Research Coordination and Professional Judgment

• Independently coordinate assigned clinical and biomedical research activities, applying specialized scientific knowledge to the execution and management of approved research protocols.

• Evaluate research requirements, protocol objectives, study methodologies, and operational constraints to determine appropriate coordination strategies within approved protocols.

• Exercise independent professional judgment in identifying scientific, procedural, or operational issues that may affect study quality, regulatory compliance, participant safety, or research timelines.

• Analyze research documentation, study progress, and collected information to identify discrepancies, emerging issues, and opportunities for improvement.

• Evaluate complex research coordination challenges and recommend appropriate solutions to the PI and other authorized research personnel.

• Independently prioritize assigned research activities, coordinate resources, and adjust operational schedules to meet established research milestones.

• Apply advanced knowledge of biological and health sciences when interpreting study requirements and coordinating research activities involving human and animal research protocols.

• Clinical Research Protocol Execution

• Coordinate the implementation and execution of assigned IRB/IACUC-approved clinical research protocols, exempt research, non-human-subject research, and quality improvement/quality assurance projects.

• Independently assess study coordination requirements and develop operational plans that support the PI's approved research objectives.

• Evaluate study eligibility criteria and assist with participant recruitment and screening, referring eligibility determinations requiring medical or PI judgment to authorized personnel.

• Coordinate patient scheduling, clinical evaluations, laboratory testing, specimen collection, and other protocol-required research activities.

• Support the informed consent process and verify that consent documentation has been completed in accordance with approved protocols and applicable requirements.

• Coordinate research procedures, including phlebotomy, electrocardiograms, intravenous infusions, vital signs, and specimen collection, as authorized by the applicable protocol and the individual's professional qualifications.

• Evaluate operational barriers affecting protocol execution and independently develop recommendations for resolution within established research and regulatory requirements.

• Regulatory Compliance and Research Quality

• Apply professional knowledge of IRB/IACUC requirements, Good Clinical Practice (GCP), applicable Federal regulations, and institutional research procedures to assigned research activities.

• Independently review research records and study activities to identify potential protocol deviations, incomplete documentation, regulatory concerns, and research quality issues.

• Assess identified issues, determine their operational significance, and recommend corrective actions to maintain compliance with approved protocols.

• Coordinate the preparation of protocol amendments, continuing reviews, adverse event reports, and protocol deviation documentation.

• Assist in evaluating research compliance trends and developing process improvements that enhance documentation accuracy and study execution.

• Ensure that reportable adverse events, protocol deviations, and other compliance concerns are promptly escalated to the PI and appropriate oversight personnel.

• Support preparation of regulatory submissions and research reports, subject to required Government review and approval.

• Research Data Evaluation and Documentation

• Independently evaluate research data for completeness, consistency, accuracy, and compliance with approved data collection procedures.

• Apply scientific and analytical judgment to identify unexpected findings, inconsistent research records, and potential data integrity concerns requiring further evaluation.

• Coordinate the collection, processing, documentation, and submission of research information in accordance with approved protocols.

• Maintain accurate research records, regulatory binders, participant documentation, and study progress reports.

• Evaluate research documentation and recommend appropriate corrective actions when discrepancies or deficiencies are identified.

• Collaborate with PIs and research scientists to support the interpretation and reporting of study progress and research findings, within the CRC's scientific qualifications and authorized responsibilities.

• Research Program Coordination and Communication

• Serve as a professional research coordination resource to assigned investigators, clinical departments, and collaborating research personnel.

• Independently organize and prioritize assigned research activities based on scientific requirements, regulatory deadlines, study milestones, and available resources.

• Coordinate with the PI to ensure personnel, equipment, supplies, laboratory services, and other research resources are available when required.

• Identify emerging research coordination risks and develop recommendations to minimize disruption to active studies.

• Communicate research status, findings, operational concerns, and recommended corrective actions to the PI and Clinical Program Manager.

• Provide research-related guidance and technical coordination support within the employee's demonstrated expertise and approved responsibilities.

• Maintain effective working relationships with Government investigators, healthcare providers, research personnel, and institutional oversight organizations.

Qualifications

Necessary Skills and Knowledge:

• Advanced knowledge of clinical or biomedical research principles, scientific methodologies, and research protocol implementation.
• Demonstrated ability to independently evaluate complex scientific and research-related information and exercise professional judgment in resolving nonroutine issues.
• Knowledge of human-subject research requirements, IRB/IACUC oversight, research ethics, and applicable institutional regulatory procedures.
• Ability to identify research quality concerns, evaluate protocol compliance risks, and recommend scientifically and procedurally appropriate corrective actions.
• Ability to assess research data and documentation for accuracy, completeness, consistency, and integrity.
• Ability to independently organize research activities, establish work priorities, and coordinate multiple concurrent studies.
• Strong analytical, problem-solving, technical writing, and professional communication skills.
• Ability to collaborate effectively with clinical investigators, research scientists, healthcare providers, and multidisciplinary research teams.
• Ability to maintain professional judgment and accountability while operating within approved research protocols and established Government decision-making authority.

Minimum Qualifications:

• Bachelor's degree from an accredited college or university in Biological Sciences, Health Sciences, Physiology, or a closely related scientific or clinical research discipline.

• The degree must provide specialized academic preparation directly applicable to the scientific and technical requirements of the assigned research responsibilities.

• The employee must demonstrate the ability to apply advanced scientific knowledge, analytical reasoning, and independent professional judgment to complex clinical or biomedical research activities.

• A bachelor's degree in a qualifying scientific or health-related discipline is required for this position. Certification or professional experience alone will not substitute for the degree requirement.

• Work Environment

• The position supports clinical and biomedical research activities at Naval Medical Center Portsmouth, including clinical departments, inpatient facilities, research laboratories, and other authorized research locations.

• The employee must be able to work collaboratively with multidisciplinary research teams, maintain professional accountability, and apply specialized scientific knowledge to changing research requirements.

• Onsite presence and telework arrangements will be established in accordance with applicable Government requirements and contract provisions.

Preferred Qualifications:

• Two or more years of experience coordinating clinical or biomedical research.
• Experience supporting research within a military treatment facility, academic medical center, hospital, or comparable clinical research institution.
• Experience with human-subject research, clinical trial coordination, IRB submissions, and regulatory documentation.
• Certification as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or comparable professional research certification.
• Experience supporting DoD or DHA clinical research programs.
• Experience evaluating complex research data, identifying protocol compliance concerns, and recommending research process improvements.

Pay and Benefits

The pay range for this position is $65,000 to $68,000 annually.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.