Senior Trauma Clinical Data Coordinator - Full Time - Day

Senior Trauma Clinical Data CoordinatorOur 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 Trauma Clinical Data Coordinator is responsible for the oversight of the data management for the Department of Trauma at Hackensack University Medical Center (HUMC). This includes, but is not limited to, research related data entry, query management, and ensuring adherence to institutional and protocol requirements while maintaining data integrity for all assigned Trauma clinical research studies. This role also supports the Trauma Program under the direction of the Trauma Research Nurse Coordinator, Trauma Program Manager and Chief of Trauma to ensure that Level 1 Trauma ACS Certification is maintained.ResponsibilitiesA day in the life of a Senior Trauma Clinical Data Coordinator at Hackensack Meridian Health includes: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.govObtains 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.QualificationsEducation, Knowledge, Skills and Abilities 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.Education, Knowledge, Skills and Abilities 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.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!