Administrative Assistant/Data Assistant, Full Time, Days - Imaging Core Lab - Morristown

Accountabilities: 

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

• Maintains patient charts in an audit preparedness manner to ensure accordance with all regulatory agencies(e.g., FDA). Assists team leaders 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 core lab team members 
• 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.
• 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.
• Prepares reports, including but not limited enrollment logs which assists with institutional statistical analysis.
• May create databases  for Investigator all studies or projects
• Oversees and facilitates the creation of data collection tools within the platform 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
• follows SOPs 
• Supports physicians administratively including calendar and scheduling of clinical procedures
• Assists with billing 

Required:

High School Diploma

Preferred:

• Bachelors Degree in health related discipline preferred
• CCRC or CCRP preferred
• 2+ years in Healthcre Setting

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:

• 100 Best Companies to Work For ® and FORTUNE® magazine for 15 years 
• Best Places to Work in Healthcare - Modern Healthcare
• 150 Top Places to work in Healthcare - Becker's Healthcare
• 100 Accountable Care Organizations to Know - Becker's Hospital Review
• Best Employers for Workers over 50 - AARP
• Gold-Level "Well Workplace": Wellness Council of America (WELCOA)
• One of the 100 Best Workplaces for “Millennials” Great Place to Work® and FORTUNE® magazine
• One of the 20 Best Workplaces in Health Care: Great Place to Work® and FORTUNE® magazine
• Official Health Care Partner of the New York Jets
• NJ Sustainable Business 

Atlantic Health System offers a competitive and comprehensive Total Rewards package that supports the health, financial security, and well-being of all team members. Offerings vary based on role level (Team Member, Director, Executive). Below is a