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SENNIOR CLINICAL RESEARCH COORDINATOR

JFK Johnson Rehabilitation Institute
Neptune, NJ Full Time
POSTED ON 4/4/2025
AVAILABLE BEFORE 5/3/2025
Sennior Clinical Research Coordinator

JERSEY SHORE UNIVERSITY MEDICAL CENTER Borough of Neptune City, New Jersey

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  • Requisition # 2025-162659
  • ShiftDay
  • StatusFull Time with Benefits

Overview

Our team members are the heart of what makes us better.

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 Senior Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, and implementing a compliant study conduct according to all relevant local, federal, and state regulatory requirements and institutional Policies and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which the role is assigned. This role is responsible for providing coverage and acting as back-up Project Manager for applicable division, as needed. In addition, this role will serve as preceptor and primary trainer for all newly hired Clinical Research Coordinators.

Responsibilities

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

  • Responsible for precepting and training of Clinical Research Coordinators.
  • Serves as primary back-up and direct coverage for Project Manager, as needed.
  • Designs, develops, and coordinates clinical trial workflows to assist with administrative clinical trial conduct, and assists Project Manager with implementation.
  • Serves as one of main points of contact for sponsors and internal departments to ensure quality data collection and clinical trial conduct, including directly assisting with internal or external audit responses.
  • Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
  • 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.
  • Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversees 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 policies.
  • Registers protocol patients with appropriate statistical centers as required.
  • Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
  • Acts as principal investigator's representative as appropriate. Including, but not limited to communicating with sponsors and their representatives, the IRB and other medical personnel.
  • 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.
  • Maintains 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.
  • Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
  • Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
  • Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as 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 health care providers and communicate with subjects to obtain follow-up information.
  • Reviews scientific literature, participates in continuing education activities, or attends conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
  • 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 as necessary.
  • Other duties and/or projects as assigned.
  • Adheres to HMH Organizational competencies and standard of behavior.

Qualifications

Education, Knowledge, Skills and Abilities Required:

  • BA/BS diploma/degree in science or healthcare field.
  • Minimum of 2 years experience in a Clinical Research Coordinator role, or at least 6 years 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 is essential.
  • Excellent organizational, presentation, documentation and interpersonal skills.
  • Excellent written and verbal communication skills.
  • Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Education, Knowledge, Skills And Abilities Preferred

  • Education on human subject research and GCP.

Licenses And Certifications Preferred

  • SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).

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

HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER

All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.

Our Network

Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility

As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.

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Awards We’ve Received

2023

US News & World Report 2023

  • HUMC - #1 Hospital in NJ & #5 in NY Metro Area

2023

US News & World Report 2023

  • Joseph M. Sanzari Children’s Hospital - #1 Children’s Hospital in NJ

2023

US News & World Report 2023

  • JSUMC - #6 Hospital in NJ

2022

2023

2023 & 2022 Magnet Designations

for 9 HMH Institutions

2022

Newsweek 2022 Best Hospitals USA

  • HUMC - #57

2022

Newsweek 2022 America’s Best Addiction Treatment Centers

Blake Recovery Center at Carrier Clinic - #2

2023

Diversity Inc. 2023

Top Hospital and Health Systems

2022

Becker’s Hospital Review 2022

  • Top Places to Work in Healthcare

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WE KEEP GETTING BETTER

At Hackensack Meridian Health, we help our patients live better, healthier lives – and we help one another succeed. Here, competitive benefits are just the beginning. It’s also about how our team members support one another and how we show up for our community. Together, we’re ready to transform health care and advance our mission to serve as a leader of positive change.

Join us and let’s keep getting better together.

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