Reg. Compliance Coordinator - Atlantic Health System

Summit, NJ

About the Job

To facilitate and oversee all regulatory processes for clinical protocol submissions to local or central IRBs as appropriate. Liaison between site, sponsor and CRO for all FDA and sponsor required documents. To oversee compliance and meet FDA requirements ensuring audit preparedness.

Management of clinical studies through the regulatory portion of the trial submission process. Ensuring regulatory integrity of assigned clinical trials from approval to closure.
Act as the main contact during pre-activation phase, correspond with the reviewing committees and personnel, and coordinate start-up meetings for new protocols.
Prepare the Informed consent document ensuring all required regulatory elements are included. Respond to any IRB contingencies timely and appropriately.
Submits protocol applications for appropriate local IRB review in a timely manner; tracks new protocols through IRBNet for contingencies, acknowledgement, or approval. Further document preparation and submission for Central IRB as required for that IRB of record.
Submits required documents for BSC ( Biosafety Committee) review as appropriate and required.
Process annual reviews, updates, protocol deviations, non-compliance, accrual closures and protocol terminations ensuring all required documents are submitted to the IRB for review and approval.
Gathers clinical and safety data needed to prepare and process applications for IRB annual renewal review and approval.
Collaborates with the Principal Investigator (PI) in completion of required regulatory documents including, but not limited to: Conflict of Interest forms, delegation of authority logs, training logs, legal agreements, investigational pharmacy forms, serious adverse event forms, etc.
Coordinates communication with investigators and members of the research team to aid in study development and oversight throughout the life-cycle of an investigator initiated clinical trial.
Participate in Clinical Trial Feasibility, Site Selection Process, and the Site Initiation Visit, which includes conducting interviews with scientists, doctors and academics and others in a network of industry experts.
Submits Investigational New Drug (IND) Applications and obtains approval from the Food and Drug Administration (FDA) for investigator-initiated clinical trials. Acts as primary contact for all FDA communication, including submission of serious adverse events, amendments, annual reports, and other submissions as required.
Coordinates research team communication, including notification of clinical trial activation, enrollment closures, protocol amendments, and final study closures. Distributes regulatory documents throughout the life cycle of clinical trial.
Must understand complex scientific terminology as well as FDA regulations guiding research
Knowledge of local and central IRB processes
Ensures proper regulatory compliance in accordance with sponsoring agency requirements. Maintains study specific regulatory binder(s) in an audit preparedness manner.
Validate staff training records (GCP, HIPPA, Human subject’s protection) as well as CV and medical licenses.
Works with auditors and auditory committees to assess trial compliance and related issues.
Acts as liaison between research team and sponsor for important clinical trial notices, updates, and monitoring visits. Mentors and trains less experienced research staff.
Develops and/or revises regulatory standard operating policies and procedures.
Performs other related duties as assigned.

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:

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

Named one of America's 50 Best Hospitals by Healthgrades, a World’s Best Hospital by Newsweek and recognized as a Best Regional Hospital in the NY Metro area by U.S. News & World Report.

Our Atlantic Neuroscience Institute is the region’s leader in neuroscience care. A hub for the New Jersey Stroke Network, we offer a broad range of advanced neurological, neurosurgical and neurodiagnostic services. We are also certified as a Level IV Epilepsy Center and home to the Gerald J. Glasser Brain Tumor Center, where more brain tumor surgeries are performed than anywhere else in New Jersey. Our CyberKnife® program is the largest and most experienced in the state. We also have a satellite emergency department in Union, NJ, which treats about 40,000 emergency cases each year.

Committed to providing exceptional care, Overlook Medical Center has achieved the prestigious Magnet® recognition. This designation from the American Nurses Credentialing Center is the highest national honor for nursing excellence. What’s more, Overlook Medical Center has advanced certification from The Joint Commission for perinatal care and is designated an Advanced Comprehensive Stroke Center. Additional Joint Commission-certified services include behavioral health care, spine surgery, wound care, and primary care medical home (PCMH).

EEO STATEMENT

Atlantic Health System, Inc. is an equal employment opportunity employer and federal contractor or subcontractor and therefore abides by applicable laws to protect applicants and employees from discrimination in hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral, and other aspects of employment, on the basis of race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, citizenship status, disability, age, genetics, or veteran status.

Source : Atlantic Health System