Clinical Data Coordinator
How have you impacted someone's life today? At Hackensack Meridian Health our teams are focused on changing the lives of our patients by providing the highest level of care each and every day. From our hospitals, rehab centers and occupational health teams to our long-term care centers and at-home care capabilities, our complete spectrum of services will allow you to apply your skills in multiple settings while building your career, all within New Jersey's premier healthcare system.
The Clinical Data Coordinator maintains essential study documents for clinical research studies and enters data onto Case Report Forms and ensures study compliance.
A day in the life of a Clinical Data Coordinator at Hackensack Meridian can be described as follows:
1. Prepares reports and assists with statistical analysis.
2. Maintains regulatory binders in accordance with FDA guidelines. Assists research nurse in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs.
3. Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers.
4. Obtains and maintains valid Dangerous Goods Shipping Certification.
5. Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack University Medical Center.
6. Obtains patient consent for minimal risk studies.
7. Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits.
8. Verifies that all patients have provided informed consent prior to entering study specific data.
9. Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.
10. Records accurate data by completing paper or electronic CRFs.
11. Resolves data queries accurately and within study specific timeframes.
12. Maintain adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely disposes of expired/closed supplies.
13. Centrifuges human specimens per study specific laboratory manual guidelines.
14. Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations.
15. Obtains and copies research related Curricula Vitae for Investigators as found on FDA form 1572, Medical Licenses for Investigators as found on FDA form 1572, Lab Certifications and Lab Normals for labs as found on FDA form 1572, Financial Disclosures for Investigators as found on FDA form 1572 and files such documents in the corresponding study specific regulatory binders.
16. Ensures regulatory binders are maintained with essential study documents.
17. Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs.
18. Reports, tracks, and files off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record.
19. Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.
20. Prepare reports, including but not limited enrollment logs which assists with institutional statistical analysis.
21. Ability to sit and concentrate at a computer workstation for a minimum of 4 hours at a single sitting.
22. Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, language, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).
23. Adheres to the standards identified in the Medical Center's Organizational Competencies.
Education, Knowledge, Skills and Abilities Required:
1. Bachelor's degree in Science (Chemistry, Biology, Nursing) or minimum of 3 years extensive experience in research that includes data abstracting, case report form completion and research regulatory reporting.
Licenses and Certifications Preferred:
1. Certified Clinical Research Professional or Certified Clinical Data Manager.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
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.