Clinical Data Coordinator - Center for Discovery & Innovation (CDI)

Hackensack Meridian Health•Hackensack, NJ

41d•$35

About The Position

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. The Center for Discovery and Innovation- CDI was established by Hackensack Meridian Health (HMH) as an academic basic and translational research enterprise to rapidly translate science innovation to the clinic and to improve outcomes for patients with cancer, infectious diseases, autoimmune disease and other acute and chronic diseases. The CDI has grown rapidly since its origins in 2019, and now has 39 labs, 200+ scientists and allied personnel supported by 78 NIH and DoD grants and more than 87 other grants and contracts. Areas of expertise include genomics, epigenetics, drug resistance, stem cell biology, drug discovery, diagnostics and biomarker development, rheumatology and pharmacology.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.