Clinical Research Coordinator

2 months ago

Lowell, Massachusetts, United States Hackensack Meridian Health Full time
About the Role

We are seeking a highly skilled Clinical Research Coordinator to join our team at Hackensack Meridian Health. As a key member of our research operations team, you will play a critical role in the coordination and oversight of clinical trials, ensuring compliance with regulatory requirements and institutional policies.

Key Responsibilities
  • Act as liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and changes within the protocol.
  • Collaborate with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols prior to submitting the study.
  • Review study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks, and oversee subject enrollment to ensure that informed consent is properly obtained and documented.
  • Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams as required.
  • Work with the study team to draft/create study-specific study orders, billing templates, and study calendars as necessary.
  • Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
  • Monitor all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
  • Register protocol patients with appropriate statistical centers as required.
  • Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
  • Act as principal investigator's representative as appropriate, communicating with sponsors and their representatives, the IRB, and other medical personnel.
  • Maintain accurate, complete, and up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.
  • Work closely with clinical research finance to ensure study patients' clinical trial-related activities are billed appropriately.
  • Schedule, coordinate, prepare, and assist for all sponsor monitor site visits and ensure all supporting documentation records are adequate and available for the visit.
  • Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
  • Ensure compliant maintenance of all required records of study activity, including case report forms, drug dispensation records, or regulatory forms.
  • Oversee and direct the requisition, collection, labeling, storage, or shipment of specimens.
  • Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
  • Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
  • Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.
  • Organize space for study equipment and supplies.
  • Participate in the development of 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, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
  • Collaborate with investigators to prepare presentations or reports of 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 and/or projects as assigned.
  • Adhere to HMH Organizational competencies and standard of behavior.
Requirements
  • Bachelor's degree in a 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 the field of 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 GCP.
Preferred Certifications
  • SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).

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