Clinical Research Coordinator

Hackensack Meridian Health•Hackensack, NJ

About The Position

The Clinical Research Coordinator coordinates and oversees the clinical operations of assigned clinical trials and participates in assessing, planning, implementing, and conducting studies in compliance with applicable local, federal, and state regulations and institutional policies and standard operating procedures. The role performs research activities under the general supervision of the principal investigator responsible for the assigned trial or trials. The coordinator works with investigators, clinical research nurses, regulatory specialists, sponsors, research finance, and other clinical personnel throughout the study lifecycle. Responsibilities include study feasibility and protocol review, budget development, participant enrollment and scheduling, coordination of study procedures and specimen handling, maintenance of study records and systems, monitoring compliance, and preparation for site visits and audits. The role also supports study documentation, reporting, protocol problem resolution, presentations, and continuing education.

Requirements

BA/BS diploma or degree in a science or healthcare field.
At least 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 and as part of a team, and to 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.

Nice To Haves

Education in human subject research and Good Clinical Practice (GCP).
SOCRA-Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), and/or Certified Clinical Research Coordinator (CCRC).

Responsibilities

Serve as liaison among principal investigators, sub-investigators, clinical research nurses, and regulatory specialists regarding regulatory matters and protocol changes.
Participate with the study team in reviewing study feasibility and potential competition with other protocols before submission.
Review studies with investigators or clinical research nurses and develop budgets outlining standard-of-care and research costs; finalize budget drafts with the budget coordinator.
Review proposed protocols for sample collection processes, data management plans, and potential subject risks; oversee enrollment and ensure informed consent is obtained and documented.
Coordinate research activities, including laboratory tests, radiology tests, and other required medical exams.
Work with the study team to create study-specific orders, billing templates, and study calendars as needed.
Schedule subjects for appointments, procedures, and inpatient stays required by study protocols.
Monitor study activities for compliance with protocols and applicable regulations and institutional policies.
Register protocol patients with appropriate statistical centers as required.
Track subject enrollment and document dropout information, including causes and contact efforts.
Represent the principal investigator as appropriate, including communication with sponsors and their representatives, the IRB, and other medical personnel.
Maintain accurate, complete, and current protocol and patient records in the clinical trial management system and other required systems, in collaboration with clinical research nurses.
Work with clinical research finance to ensure appropriate billing for study-related patient activities.
Schedule, coordinate, prepare for, and assist with sponsor monitor site visits; ensure supporting records are available, meet with the monitor at least once per visit, and resolve issues identified.
Maintain sponsor contact to coordinate site visits and answer questions, including questions about incomplete data.
Maintain required study records in compliance, including case report forms, drug dispensation records, and regulatory forms.
Oversee requisition, collection, labeling, storage, and shipment of specimens.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies, or designated review groups.
Prepare study documentation, including protocol worksheets, procedural manuals, adverse event reports, IRB documents, and progress reports.
Identify protocol problems, inform investigators, and assist with resolution efforts such as protocol revisions.
Organize space for study equipment and supplies.
Participate in developing study protocols, including guidelines for administration or data collection procedures.
Contact outside healthcare providers and communicate with subjects to obtain follow-up information.
Review scientific literature and participate in continuing education or conferences and seminars to maintain current knowledge of clinical study affairs and issues.
Collaborate with investigators to prepare presentations or reports on clinical study procedures, results, and conclusions.
Attend research meetings and conferences as required.
Participate in staff meetings and in-service education as necessary.
Perform other duties or projects as assigned.
Adhere to HMH organizational competencies and standards of behavior.