At Virtua Health, we exist for one reason – to better serve you. That means being here for you in all the moments that matter, striving each day to connect you to the care you need. Whether that's wellness and prevention, experienced specialists, life-changing care, or something in-between – we are your partner in health devoted to building a healthier community. 
 
If you live or work in South Jersey, exceptional care is all around. Our medical and surgical experts are among the best in the country. We assembled more than 14,000 colleagues, including over 2,850 skilled and compassionate doctors, physician assistants, and nurse practitioners equipped with the latest technologies, treatments, and techniques to provide exceptional care close to home. A Magnet-recognized health system ranked by U.S. News and World Report, we've received multiple awards for quality, safety, and outstanding work environment.

In addition to five hospitals, seven emergency departments, seven urgent care centers, and more than 280 other locations, we're committed to the well-being of the community. That means bringing life-changing resources and health services directly into our communities through our Eat Well food access program, telehealth, home health, rehabilitation, mobile screenings, paramedic programs, and convenient online scheduling. We're also affiliated with Penn Medicine for cancer and neurosciences, and the Children's Hospital of Philadelphia for pediatrics.

Location:

Moorestown - 350 Young Ave.

Remote Type:

Hybrid

Employment Type:

Employee

Employment Classification:

Regular

Time Type:

Full time

Work Shift:

1st Shift (United States of America)

Total Weekly Hours:

40

Additional Locations:

Voorhees - 100 Bowman Drive

Job Information:

Schedule:
Monday through Friday, 8:00am to 4:30pm

Local onsite work required - Commutable distance to Marlton, NJ preferred

Job Summary:

 Coordinates regulatory activities for participation in phase II -IV clinical trials. Prepares and processes all regulatory documentation to support the Clinical Research Program in managing IRB documents and protocols for the IRB, central IRB, external IRBs and all applicable regulatory review committees including new submissions, continuing reviews, amendments, adverse events, and reportable events.  Organizes and maintains regulatory documents for assigned protocols. Participates in quality audits.

Position Responsibilities:

Prepares and submits regulatory documents and correspondence for Institutional Review Board (IRB), including preparation of new and renewal applications, amendments, continuing reviews, reportable events , consent forms, revised consent forms, protocol deviations, adverse event reporting etc.  Works with local IRB, external IRBs , Central IRB and research review committee to ensure all appropriate reports and required regulatory documents are completed and filed accurately and timely in compliance with  regulatory agencies.  Keeps Principal Investigators, sub-investigators and study team informed regarding regulatory operations and activation process. 

Manages and organizes regulatory study documentation and study files in accordance with sponsor, regulatory requirements and internal policies and procedures including, but not limited to, study protocols, consents, amendments,  financial disclosure forms, FDA 1572 forms, study site logs and other essential documents.  Develops regulatory standard operation and procedures that align with clinical research best practices.  Prepares and organizes all regulatory documents for audits and monitoring visits.  Participates in quality audits.

 Conducts administrative and regulatory activities related to support the conduct of clinical trials and daily operation of the clinical research program assisting with study implementation, study close-out, follow-up, and the facilitation of communication between study sites, principal investigators, sub-investigators, clinical research team and IRB. Ensures all Principal Investigators, Sub-investigators and study team are up to date with all required regulatory training.

 Attends study team meetings, sponsor meetings, and in-service education as required. Conducts financial tracking for clinical trials, invoicing sponsors and tracking payments received.  Conducts