Clinical Data Coordinator
Company: Hackensack University Medical Center
Posted on: June 8, 2021
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 ofa Clinical Data Coordinator at Hackensack
Meridian Health includes:
- Prepares reports and assists with statistical analysis.
- 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
- Assures timely submissions of research data, laboratory
specimens, and query correspondences to all research affiliates and
- Obtains and maintains valid Dangerous Goods Shipping
- 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.
- Obtains patient consent for minimal risk studies.
- 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.
- 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
- Resolves data queries accurately and within study specific
- Maintain adequate inventory of research supplies necessary for
research activities. Ensures supplies and kits are current and
safely disposes of expired/closed supplies.
- Centrifuges human specimens per study specific laboratory
- Processes and ships human specimens and biologic agents per
protocol guidelines and Federal Regulations.
- 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
- Ensures regulatory binders are maintained with essential study
- Maintains timely patient follow-up by accurately reviewing the
study specific follow-up schedule in the protocol and completes
- 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.
- Utilizes the SAE reporting log to track the receipt, submission
and acknowledgement of off-site SAEs per protocol.
- Prepare reports, including but not limited enrollment logs
which assists with institutional statistical analysis.
- Ability to sit and concentrate at a computer workstation for a
minimum of 4 hours at a single sitting.
- 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.).
- Adheres to the standards identified in the Medical Center's
Education, Knowledge, Skills and Abilities Required:
- 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
Licenses and Certifications Preferred:
- Certified Clinical Research Professional or Certified Clinical
If you feel that the above description speaks directly to your
strengths and capabilities, then please apply today!
Keywords: Hackensack University Medical Center, Hackensack , Clinical Data Coordinator, Other , Hackensack, New Jersey
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