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Clinical Data Coordinator

Company: Hackensack Meridian Health
Location: Hackensack
Posted on: June 7, 2018

Job Description:

*

CLINICAL DATA COORDINATOR

Job ID

2018-53459

Department

Cancer Ctr Clinical Research

Site

Hackensack University Medical Center

Job Location

US-NJ-Hackensack

Position Type

Full Time with Benefits

Standard Hours Per Week

40

Shift

Day

Shift Hours

8 a.m. - 4:30 p.m.

Weekend Work

No Weekends Required

On Call Work

No On-Call Required

OVERVIEW

The Clinical Data Coordinator maintains essential study documents for clinical research studies and enters data onto Case Report Forms and ensures study compliance

RESPONSIBILITIES

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

QUALIFICATIONS

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. Education, Knowledge, Skills and Abilities Preferred: Licenses and Certifications Required: Licenses and Certifications Preferred: 1. Certified Clinical Research Professional or Certified Clinical Data Manager

Meridian Health is committed to the principles of equal employment opportunity and affirmative action and will not discriminate in the recruitment or employment practices on the basis of race, color, creed, national origin, ancestry, marital status, gender, age, religion, sexual orientation, gender identity/expression, disability, veteran status and any other category protected by federal or state law.

Keywords: Hackensack Meridian Health, Hackensack, Clinical Data Coordinator, Healthcare, Hackensack, New Jersey

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