Regulatory Specialist

Hackensack Meridian Health•Hackensack, NJ

2d•Onsite

About The Position

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP) and Institutional policies. The Regulatory Specialist will serve as liaison to investigators, collaborating divisions, departments and institutions, the Institutional Review Board (IRB) and external regulatory agencies.

Requirements

BA/BS degree in the science/health care field or communication field or equivalent related education and experience.
Strong attention to detail and customer service focus.
Excellent communication, organizational, presentation, documentation, and interpersonal skills are required.
Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required.
Review and comply with all relevant HUMC and Business Unit policies and procedures, and local, state, and Federal laws and regulations.

Nice To Haves

Minimum 3 years of experience in the field or in a related area.
Mandatory education on human subject research and GCP.
Knowledge of clinical trials.
Familiarity with basic scientific principles and terminology.
Ability to work in a fast-paced environment and manage competing tasks and demands.
Certified Clinical Research Professional.
Certified Clinical Research Coordinator.
Certified Clinical Research Associate.

Responsibilities

Organizes and maintains the regulatory binder; file essential documents, obtain signatures for delegation logs, training logs and other essential study documents.
Reviews sponsor template and site level Informed Consent Forms (ICF) to assure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
Participates in the regulatory review, preparation, and submission of clinical study documentation (e.g. investigator brochure, Investigational Device Exemption (IDE), Investigational New Drug (IND), treatment and compassionate/emergent use, etc) as required.
Ensures timeliness and accurate submission of all protocol amendments, ICF, Investigator Brochure and other administrative items to the IRB of record.
Arranges for receipt and/or transmission of administrative and regulatory documents and files Serious Adeverse Event (SAE) and IND safety reports.
Reviews and interprets IRB correspondence with the research team and notifies team of all determinations that may affect the safety and welfare of human subjects.
Obtains and maintains updated lab/test ranges.
Updates electronic databases for any personnel changes.
Acts as liaison between investigators, sponsors and their representative and the IRB on all regulatory issues.
Assist investigators in obtaining necessary access to facilitate research readiness.
Provides timely follow-up, issue resolution, update reports and problem escalation as necessary.
Attends and actively participates in study team meetings, sponsor meetings and research meetings, and conferences/in-service education sessions as required.
Prepares the regulatory binder for monitor visits, audits or site inspections.
Performs other work-related duties as assigned.
Assists with orienting new staff on their regulatory responsibilities.
Serves as a resource for questions related to regulations affecting clinical research.
Stays abreast of developments in GCP and federal regulations regarding clinical research.
Maintains overall awareness in the field of clinical research, as well as assigned areas, by reading related literature, attending training classes, attending professional meetings, etc.
Assists in developing procedures to ensure regulatory compliance.
Adheres to the standards set forth in the Medical Center's Employee Handbook.