Sr Clinical Data Coordinator

Hackensack Meridian Health•Hackensack, NJ

1d•$35•Onsite

About The Position

The Sr. Clinical Data Coordinator is responsible for the oversight of the data management process for their respective division(s) or assignments. This includes, but is not limited to, data entry, query management, and ensuring adherence to institutional and protocol requirements while maintaining data integrity for all assigned clinical research studies.

Requirements

BA/BS diploma/degree in science or healthcare field OR minimum of 4 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 4 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.
SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).

Responsibilities

Onboards newly hired research personnel within the data team and/or other team members: a. Develops onboarding training materials related to the clinical data coordinator process and responsibilities for newly hired team members as needed. b. Provides guidance and oversight throughout the duration of the onboarding process for all newly hired Clinical Data Coordinators. c. Provides updates and recommendations regarding onboarding of all newly hired personnel, including extending onboarding and training when needed. d. Provides overview of data requirements to newly hired research staff.
Assists in developing processes and procedures to help ensure data compliance.
Ensures that electronic databases contain accurate, complete and up-to-date records of each patient participating in a clinical trial and reviews source documents for completeness.
Provides cross coverage to other divisions on an as needed basis or at the leader's request.
Services as primary point of contact for any workflow related to data collection.
Communicates as needed with sponsors and their representatives, the IRB, and other medical personnel.
Prepares and assists for sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit. Corresponds with the monitor to provide timely follow-up, issue resolution.
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 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.