Clinical Data Coordinator

2+ years

Not Disclosed

Hackensack

15 June 17, 2024

Job Description

Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

OVERVIEW

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 Clinical Data Coordinator is responsible for data entry and query management, and ensures adherence to institutional and protocol requirements while maintaining data integrity for all assigned clinical research studies.

RESPONSIBILITIES

A day in the life of a Clinical Data Coordinator at Hackensack Meridian Health includes:

Assures timely submissions of research data, and query correspondences to all research affiliates and statistical centers. Assures timely submissions of laboratory specimens as needed.
Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Clinical Research Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack Meridian Health.
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.
Obtains consent for minimal risk studies Verifies that all patients have provided informed consent prior to entering study specific data.
Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.
Records accurate data by completing paper or electronic CRFs.
Resolves data queries accurately and within study specific timeframes.
Maintains adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely dispose of expired/closed supplies.
Centrifuges human specimens per study specific laboratory manual guidelines as needed. Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations as needed.
Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs.
Prepares reports, including but not limited enrollment logs which assists with institutional statistical analysis.
Attends and actively participates in division meetings division meetings, sponsor meetings and research meetings, and 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.

QUALIFICATIONS

Education, Knowledge, Skills and Abilities Required:

BA/BS diploma/degree in science or healthcare field OR minimum of 2 or more years of experience in a related area with High School diploma, general equivalency diploma (GED), and/or GED equivalent programs.
Strong attention to detail and customer service focus.
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 2 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:

Certified Clinical Research Professional or Certified Clinical Research Coordinator or Certified Clinical Research Administrator.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

OUR NETWORK

Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility

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.

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