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At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. The Clinical Research Coordinator carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which he/she is assigned.

A day in the life of a Clinical Research Coordinator at Hackensack Meridian Health includes:

• Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
• In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
• Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
• Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required.
• Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary.
• Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols.
• Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• 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. This may include communicating with sponsors and their representatives, the IRB and other medical personnel.
• Along with clinical research nurses, maintains accurate, complete, 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.
• Works closely with clinical research finance to ensure study patient's clinical trial related activities are billed appropriately.
• Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Oversees and directs 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 health care 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.
• Attends research meetings and conferences as required.
• Participates in staff meetings and in-service education of nursing and medical staff.
• Adheres to the standards identified in the Medical Center's Organizational Competencies.

Education, Knowledge, Skills and Abilities Required:

• BA/BS degree in the science/health care field or significant equivalent related education and experience.
• Minimum 5 years of experience in the field or in a related area.
• Strong attention to detail and customer service focus is required.
• Excellent communication, organizational, presentation, documentation, and interpersonal skills are required.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email (Outlook), and voicemail is required.
• Review and comply with all relevant HUMC and Business Unit policies and procedures, and local, state, and Federal laws and regulations.

Education, Knowledge, Skills and Abilities Preferred:

• Mandatory education on human subject research and GCP (CITI Training and Certification).
• Knowledge of clinical trials and the regulation (local, state, and federal) of such.
• Familiarity with basic scientific and healthcare principles and terminology.
• Ability to work in a fast-paced environment and manage competing tasks and demands.

Licenses and Certifications Preferred:

• Certified Clinical Research Professional or Certified Clinical Research Associate or Certified Clinical Research Coordinator.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!