Clinical Research Data Coordinator - Atlantic Health - Morristown Medical Center

Atlantic Health System•Morristown, NJ

1d•$25 - $42•Onsite

About The Position

This role oversees and facilitates the collection and submission of clinical data as per protocol, sponsor, and contractual requirements. Creates databases and data collection tools as needed for investigator initiated clinical research studies/projects. Oversees all data compliance in accordance with sponsor, contract and regulatory agencies regulations and requirements.

Requirements

Oversees and facilitates the collection and submission of clinical data as per protocol, sponsor, and contractual requirements.
Creates databases and data collection tools as needed for investigator initiated clinical research studies/projects.
Oversees all data compliance in accordance with sponsor, contract and regulatory agencies regulations and requirements.
Maintains patient binders in an audit preparedness manner to ensure accordance with all regulatory agencies (e.g., FDA).
Assists research nurse in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs.
Assures timely and accurate submissions of research data and query resolution as per contract requirements.
Communicates to all sponsors, CROs and statistical centers as need related to data.
Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations.
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 (C RF) in order to correctly capture study specific data points on the CRFs.
Collects and records study data from various source documents by into different case report systems.
Resolves data queries accurately and within contract and study specific timeframes.
Maintains timely patient follow-up data by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs.
May conduct long-term patient follow up visits, including documentation of the conversation and submission of the required data.
Reports and tracks Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record.
Prepares reports, including but not limited enrollment logs which assists with institutional statistical analysis.
May create databases in RedCap or other platform for Investigator initiated clinical research studies or projects
Oversees and facilitates the creation of data collection tools within the platform (e.g. RedCap).
Exports data and reviews with principal investigator as appropriate.
Collates data and assists in abstract preparation as needed.
Covers and assists regulatory staff as needed, including but not limited to maintaining regulatory documentation and binders; processing internal and external SAE reports; obtaining signatures; facilitating addition of study personnel; and processing IRB submissions.

Responsibilities

Maintains patient binders in an audit preparedness manner to ensure accordance with all regulatory agencies (e.g., FDA). Assists research nurse in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs.
Assures timely and accurate submissions of research data and query resolution as per contract requirements. Communicates to all sponsors, CROs and statistical centers as need related to data.
Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations.
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 (C RF) in order to correctly capture study specific data points on the CRFs.
Collects and records study data from various source documents by into different case report systems. Resolves data queries accurately and within contract and study specific timeframes.
Maintains timely patient follow-up data by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs. May conduct long-term patient follow up visits, including documentation of the conversation and submission of the required data.
Reports and tracks Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record. Prepares reports, including but not limited enrollment logs which assists with institutional statistical analysis. May create databases in RedCap or other platform for Investigator initiated clinical research studies or projects
Oversees and facilitates the creation of data collection tools within the platform (e.g. RedCap). Exports data and reviews with principal investigator as appropriate. Collates data and assists in abstract preparation as needed.
Covers and assists regulatory staff as needed, including but not limited to maintaining regulatory documentation and binders; processing internal and external SAE reports; obtaining signatures; facilitating addition of study personnel; and processing IRB submissions.

Benefits

Medical, Dental, Vision, Prescription Coverage (22.5 hours per week or above for full-time and part-time team members)
Life & AD&D Insurance.
Short-Term and Long-Term Disability (with options to supplement)
403(b) Retirement Plan: Employer match, additional non-elective contribution
PTO & Paid Sick Leave
Tuition Assistance, Advancement & Academic Advising
Parental, Adoption, Surrogacy Leave
Backup and On-Site Childcare
Well-Being Rewards
Employee Assistance Program (EAP)
Fertility Benefits, Healthy Pregnancy Program
Flexible Spending & Commuter Accounts
Pet, Home & Auto, Identity Theft and Legal Insurance