Hackensack Meridian Health · 1 week ago
Sr Trauma Clinical Data Coord - Full Time - Day
Hackensack Meridian Health is dedicated to improving patient lives and fostering a collaborative work environment. The Senior Trauma Clinical Data Coordinator oversees data management for the Trauma Department, ensuring adherence to research protocols and maintaining data integrity for clinical studies.
Assisted LivingHealth CareHealth DiagnosticsHospitalMedical
Responsibilities
Works in collaboration with Trauma principal investigators, sub-investigators, Trauma Research RN, and regulatory specialists on all research issues ensuring adherence to trauma research protocols
Participates in Investigator initiated protocol development and feasibility by gathering data and performing literature reviews using PubMed
Assists with reviewing, editing research abstracts, presentations, and manuscripts and format accordingly for journal submissions
Assists in preparation and submissions of institutional review board applications, continuing reviews, amendments, and safety reports
Assists with submitting and updating eligible protocols onto clinicaltrials.gov
Obtains and maintains necessary documents required for FDA form 1572: Curricula Vitae for Investigators, Medical Licenses, Lab Certifications and Lab Normal Ranges, Financial Disclosures
Performs daily screening and tracking on incoming trauma/surgical patients for eligible trauma studies
Consents eligible subjects for minimal risk studies. Ensure that informed consent is properly obtained and documented prior to entering study specific data
Assists in coordination with Physicians, Physician Assistants, Residents, Surgeons and Nurses in research study sample acquisition
Maintains adequate inventory of research supplies necessary for research activities. Ensure supplies and kits are current and safely disposed of expired/closed supplies
Centrifuges, processes, and ships human specimens/biologic agents per study specific laboratory manual guidelines and Federal Regulations as needed
Maintains subject records, performs detailed chart abstraction from medical record and data entry for PI initiated, sponsors multi-institutional studies
Resolves data queries accurately and within study specific timeframes for both research and quality improvement projects
Assists with REDCAP research project design and management to ensure data integrity in preparation for statistical analysis
Assures timely submissions of research data, and query correspondences to all research affiliates and statistical centers. Assures timely submissions of laboratory specimens as needed
Ensures that electronic databases contain accurate, complete and up-to-date records of each patient participating in a clinical trial and reviews source documents for completeness according to protocol requirements
Prepares, assists and attends sponsor monitor site visits and ensure all supporting documentation records are adequate and available for the visit. Correspond with the monitor to provide timely follow-up, issue resolution
Assists with regulatory guidance, training and managing medical students, residents and volunteers assigned to trauma research projects
Works closely with Business Intelligence (DTS) to obtain and run accurate reports from EPIC as needed
Prepares reports and assists with statistical analysis under the auspices of the trauma research team and Trauma Department
Identifies and tags incoming trauma patients using EPIC and BI reports
Assists with trauma registry data entry, running reports and data validation using all ACS TQIP related databases
Assists with patient upload from EPIC to Trauma Registry as needed
Assists in the preparation and submission of Trauma Registry data NJ State and ACS as needed
Assists in the preparation for ACS-COT trauma re-verification visits
Participates in continuing education activities such as TQIP monthly education, or attend conferences and seminars to maintain current knowledge of Trauma/Surgical clinical studies affairs and issues
Attends and actively participates in division meetings, sponsor meetings and research meetings, conferences/in-service education sessions as required. Including but not limited to study Site Initiation Visits and Study Close Out Visits
Other duties and/or projects as assigned
Adheres to HMH Organizational competencies and standards of behavior
Qualification
Required
Bachelor of Arts/Bachelor of Science diploma/degree in science or healthcare field OR minimum of 4+ years of experience in a related area with High School diploma, general equivalency diploma (GED), and/or GED equivalent programs
Strong attention to detail
Advanced knowledge in Medical Terminology
Advanced/Expert knowledge in electronic medical record (EPIC)
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
Preferred
Minimum of 4 or more years of extensive experience in research that includes data abstracting, case report form completion and research regulatory reporting
Education on human subject research and GCP
SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC)
Benefits
Health
Dental
Vision
Paid leave
Tuition reimbursement
Retirement benefits
Company
Hackensack Meridian Health
Hackensack Meridian Health is a health care organization that offers research and medical services.
Funding
Current Stage
Late StageTotal Funding
$36.3MKey Investors
Baldrick's FoundationNational Institutes of Health
2023-11-21Grant
2023-02-24Grant· $3M
2019-05-10Grant· $33.3M
Leadership Team
Recent News
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2026-01-20
2025-12-15
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