Clinical Research Coordinator

About the Role

At Hackensack Meridian Health, our team members are the heart of what makes us better. We help our patients live better, healthier lives and support one another to succeed. With a culture rooted in connection and collaboration, our employees thrive in a team-oriented environment. This role coordinates and oversees clinical operations for assigned clinical trials, ensuring compliant study conduct according to all relevant local, federal, and state regulatory and institutional policies and standard operating procedures. The Clinical Research Coordinator works under the general supervision of the principal investigator responsible for the clinical trial(s).

Responsibilities

• Acts as liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and protocol changes.
• Collaborates with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols prior to submission.
• Reviews study protocols with the principal investigator and/or clinical research nurses to outline standard of care and research costs, finalizing budget drafts with the budget coordinator.
• Evaluates proposed study protocols for factors such as sample collection processes, data management plans, and potential subject risks.
• Oversees subject enrollment to ensure proper informed consent is obtained and documented.
• Coordinates research activities, including scheduling laboratory tests, radiology testing, and other medical exams as required by study protocols.
• Works with the study team to draft study-specific orders, billing templates, and study calendars.
• Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols.
• Monitors study activities to ensure compliance with protocols and all relevant regulatory and institutional policies.
• Registers protocol patients with appropriate statistical centers as required.
• Tracks enrollment status of subjects and documents dropout information, including causes and contact efforts.
• Acts as the principal investigator’s representative, communicating with sponsors, IRBs, and other medical personnel.
• Maintains accurate, complete, and up-to-date records for each protocol and patient in the clinical trial management system and other required systems.
• Works closely with clinical research finance to ensure appropriate billing for clinical trial-related activities.
• Schedules, coordinates, prepares, and assists with all sponsor monitor site visits, ensuring all supporting documentation is available and resolving issues identified during visits.
• Maintains contact with sponsors to schedule site visits or address questions about issues such as incomplete data.
• Ensures compliant maintenance of all required study records, including case report forms, drug dispensation records, and regulatory forms.
• Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, IRB documents, and progress reports.
• Identifies protocol problems, informs investigators, and assists in problem resolution efforts, including protocol revisions.
• Organizes space for study equipment and supplies.
• Participates in the development of study protocols, including guidelines for administration or data collection procedures.
• Contacts outside healthcare providers and communicates with subjects to obtain follow-up information.
• Reviews scientific literature, participates in continuing education, or attends conferences to maintain current knowledge of clinical studies.
• Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Attends research meetings and conferences as required.
• Participates in staff meetings and in-service education.
• Performs other duties and/or projects as assigned.
• Adheres to HMH organizational competencies and standards of behavior.

Requirements

• BA/BS diploma/degree in science or healthcare field.
• Minimum of 2 years of experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years of related experience in clinical research.
• Strong attention to detail and customer service focus.
• Ability to work independently or in a team and handle multiple deadline-driven tasks in a dynamic environment.
• Excellent organizational, presentation, documentation, and interpersonal skills.
• Excellent written and verbal communication skills.
• Proficient computer skills, including Microsoft Office and/or Google Suite platforms.

Preferred Qualifications

• Education on human subject research and Good Clinical Practice (GCP).
• Certifications such as SOCRA-Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Certified Clinical Research Coordinator (CCRC).

Pay

The posted rate of pay for this role is a reasonable good faith estimate of the minimum base pay in accordance with the New Jersey Pay Transparency Act. The starting rate of pay is $83,782.40 annually. The final base compensation may vary based on factors such as labor market data, experience, education, certifications, skills, geographic location, internal equity, and budget or grant funding.

Benefits

Hackensack Meridian Health offers a comprehensive benefits package for full-time and part-time (20+ hours/week) employees, including:

• Health, dental, and vision coverage.
• Paid leave.
• Tuition reimbursement.
• Retirement benefits.
• Eligibility for performance-based incentives, bonuses, or commissions (for certain positions).
• Shift differentials for work performed on evening, night, or weekend shifts (for eligible positions).