Senior Trauma Clinical Data Coordinator - Full Time - Day

About the role

At Hackensack Meridian Health, the Senior Trauma Clinical Data Coordinator oversees data management for the Department of Trauma at Hackensack University Medical Center (HUMC). This role supports trauma clinical research studies, ensuring data integrity and adherence to institutional and protocol requirements. Additionally, the position supports the Trauma Program to maintain Level 1 Trauma ACS Certification under the direction of the Trauma Research Nurse Coordinator, Trauma Program Manager, and Chief of Trauma.

Responsibilities

• Collaborate with Trauma principal investigators, sub-investigators, Trauma Research RN, and regulatory specialists to ensure adherence to trauma research protocols.
• Participate in Investigator-initiated protocol development and feasibility by gathering data and performing literature reviews using PubMed.
• Assist with reviewing, editing, and formatting research abstracts, presentations, and manuscripts for journal submissions.
• Prepare and submit institutional review board applications, continuing reviews, amendments, and safety reports.
• Submit and update eligible protocols on clinicaltrials.gov.
• Obtain and maintain necessary documents required for FDA form 1572, including Curricula Vitae, Medical Licenses, Lab Certifications, and Financial Disclosures.
• Perform daily screening and tracking of incoming trauma/surgical patients for eligible trauma studies; consent eligible subjects for minimal risk studies.
• Ensure proper informed consent documentation prior to entering study-specific data.
• Coordinate with physicians, physician assistants, residents, surgeons, and nurses for research study sample acquisition.
• Maintain adequate inventory of research supplies and safely dispose of expired/closed supplies.
• Process, centrifuge, and ship human specimens/biologic agents per study-specific laboratory manual guidelines and Federal Regulations.
• Maintain subject records, perform detailed chart abstraction from medical records, and enter data for PI-initiated and sponsor multi-institutional studies.
• Resolve data queries accurately and within study-specific timeframes for research and quality improvement projects.
• Assist with REDCap research project design and management to ensure data integrity for statistical analysis.
• Ensure timely submissions of research data, query correspondences, and laboratory specimens to research affiliates and statistical centers.
• Ensure electronic databases contain accurate, complete, and up-to-date records of each patient participating in clinical trials; review source documents for completeness.
• Prepare, assist, and attend sponsor monitor site visits; ensure all supporting documentation is available and correspond with monitors for timely follow-up.
• Provide regulatory guidance, training, and manage medical students, residents, and volunteers assigned to trauma research projects.
• Work closely with Business Intelligence (DTS) to obtain and run accurate reports from EPIC as needed.
• Prepare reports and assist with statistical analysis under the auspices of the trauma research team and Trauma Department.
• Identify and tag incoming trauma patients using EPIC and BI reports.
• Assist with trauma registry data entry, running reports, and data validation using ACS TQIP-related databases.
• Assist with patient upload from EPIC to Trauma Registry as needed.
• Prepare and submit Trauma Registry data to NJ State and ACS as required.
• Assist in preparation for ACS-COT trauma re-verification visits.
• Participate in continuing education activities such as TQIP monthly education, conferences, and seminars to maintain current knowledge of Trauma/Surgical clinical studies.
• Attend and actively participate in division meetings, sponsor meetings, research meetings, and in-service education sessions, including Site Initiation Visits and Study Close Out Visits.
• Perform other duties and/or projects as assigned.
• Adhere to HMH Organizational competencies and standards of behavior.

Requirements

• Bachelor of Arts/Bachelor of Science degree in science or healthcare field OR minimum of 4+ years of experience in a related area with a High School diploma, GED, or equivalent.
• Strong attention to detail.
• Advanced knowledge of Medical Terminology.
• Advanced/Expert knowledge of electronic medical records (EPIC).
• 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.

Qualifications (Preferred)

• Minimum of 4 or more years of extensive experience in research, including data abstracting, case report form completion, and research regulatory reporting.
• Education on human subject research and Good Clinical Practice (GCP).
• Certifications such as SOCRA-Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Certified Clinical Research Coordinator (CCRC).

Pay

Minimum starting rate of $35.17 per hour. The posted rate is a reasonable good faith estimate of the minimum base pay for this role at the time of posting. The base compensation may vary based on factors including labor market data, experience, education, certifications, skills, geographic location, internal equity, budget, and grant funding. Full-time and part-time (20+ hours/week) positions may be eligible for performance-based incentives, bonuses, commissions, or shift differentials for evening, night, or weekend shifts.

Benefits

Hackensack Meridian Health offers a comprehensive benefits package for full-time and part-time (20+ hours/week) employees, including:

• Health, dental, and vision insurance.
• Paid leave.
• Tuition reimbursement.
• Retirement benefits.