Clinical Research Data Coord. - Morristown

Job Description

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. 

Job Responsibilities along with a percentage of time performing duties 

• 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 (CRF) 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 

EducationBachelor’s degree required in health related discipline preferredExperience1-2 years health care experience, research experience preferred CertificatesCCRC or CCRP preferred

ABOUT US

At Atlantic Health System, our promise to our communities is;  Anyone who enters one of our facilities, will receive the highest quality care delivered at the right time, at the right place, and at the right cost. This commitment is also echoed in the respect, development and opportunities we give to our more than 20,000 team members. Headquartered in Morristown, New Jersey, we are one of the leading non-profit health care systems in the nation. Our facilities and sites of care include:

• Morristown Medical Center, Morristown, NJ
• Overlook Medical Center, Summit, NJ
• Newton Medical Center, Newton, NJ
• Chilton Medical Center, Pompton Plains, NJ
• Hackettstown Medical Center, Hackettstown, NJ
• Goryeb Children's Hospital, Morristown, NJ
• CentraState Healthcare System, Freehold, NJ
• Atlantic Home Care and Hospice
• Atlantic Mobile Health
• Atlantic Rehabilitation

We also have more than 900 community-based healthcare providers affiliated through Atlantic Medical Group. Atlantic Accountable Care Organization is one of the largest ACOs in the nation, and we are a member of AllSpire Health Partners.

We have received awards and recognition for  the services we have provided to our patients, team members and communities. Below are just a few of our accolades: