Sr Trauma Clinical Data Coord

Sr Trauma Clinical Data Coord - Full Time - Day

Hackensack University Medical Center – Hackensack, New Jersey

Requisition #:

Shift: Day
Status:
Full Time with Benefits

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 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.

• 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 Pub Med.
• 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 clinical trials.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. Ensures 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. Ensures 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 and sponsor multi-institutional studies.
• Resolves data queries accurately and within study specific time frames 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. Corresponds 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…