Clinical Research Coordinator

Goldbelt Apex LLC is a data-focused healthcare technology company supporting healthcare organizations with data communication and exchange systems. The Clinical Research Coordinator will independently coordinate complex clinical and biomedical research activities for the Defense Health Agency Clinical Investigation Program at Naval Medical Center Portsmouth, including protocol execution, regulatory compliance, research data evaluation, documentation, and communication with investigators and clinical teams.

Responsibilities

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

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

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

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

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

Preferred

* 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

* Two or more years of experience coordinating clinical or biomedical research.

Clinical Research Coordination

Biomedical Research Coordination

Clinical Research Institution Experience

Clinical Trial Coordination

IRB Submissions

Regulatory Documentation

CCRC Certification

CCRP Certification

DoD Clinical Research

DHA Clinical Research

Complex Research Data Analysis

Protocol Compliance Evaluation

Analytical Thinking

Process Improvement

Benefits

Medical, dental, and vision insurance

A 401(k) plan with company matching

Tax-deferred savings options

Supplementary benefits

Paid time off

Professional development opportunities

Company

Interoperable healthcare data ecosystems for improved care models

Juneau, Alaska, USA

http://goldbelt.com/

Founded in 1974

51-200 employees

Qualifications

* 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

* 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

* 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

Required skills

Clinical Research Coordination, Biomedical Research, Research Protocol Implementation, Human-Subject Research, IRB/IACUC Compliance, Clinical Practice (GCP), Clinical Trial Coordination, Regulatory Documentation, Research Data Evaluation, DoD/DHA Clinical Research

Experience

2+ years