Regulatory Specialist

Overview

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 ensuring compliance with Federal, State, and Local Regulations, Good Clinical Practice (GCP), and Institutional policies and procedures. This role will serve as a regulatory liaison to internal and external investigators, sponsors, collaborating divisions, departments and institutions, and Institutional Review Boards (IRBs), Data Safety and Monitoring Boards, Biosafety committees, Laboratory facilities, and external regulatory agencies. This role is the primary point of contact and is responsible for the scheduling, preparation for and facilitation of conduct of all internal and external audits as well as ensuring ongoing compliance of study-related documentation throughout the clinical trial lifecycle for all assigned clinical trials.

A day in the life of a Regulatory Specialist at Hackensack Meridian Health includes:

• Organizes and maintains in audit ready condition at all times the regulatory binder (paper or electronic); files essential documents, obtains 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 ICH guidelines.
• Provides access to the most updated approved protocol and related documents to the team via an established electronic process.
• Tracks/updates all changes to informed consents and send to sponsor for pre review prior to IRB submission.
• Creates short forms for any translated language requested by the clinical team.
• Requests updated translations for all patient facing documents as needed for the clinical team.
• Participates in the regulatory review, preparation, and submission of clinical study documentation (e.g. investigator brochure, IDE, IND, treatment and compassionate/emergent use, etc) as required.
• Ensures timeliness and accurate submission of all protocol continuing reviews, protocol amendments, ICFs, Investigator Brochures and other administrative items to the IRB of record.
• Notifies finance and contract teams of amendments that require updates to the Medicare Coverage Analysis, budget and contract for a clinical trial in order to initiate a review in tandem with IRB review.
• Updates Oncore via Task Lists regarding all amendments under review and assigns appropriate contract and budget specialist.
• Ensure the accurate updating and maintenance of regulatory documents pertaining to the DSMB, Biosafety Committee, and the Protocol Review Committee.
• Arranges for receipt and/or transmission of administrative and regulatory documents and files Serious Adverse Event (SAE) and IND safety reports
• Reviews and interprets IRB correspondence with the research team and notifies the team of all determinations that may affect the safety and welfare of human subjects.
• Obtains and maintains updated lab/test ranges.
• Updates electronic databases including but not limited to any personnel changes and study status changes related to the clinical trial in a timely manner.
• Acts as liaison between investigators, sponsors and their representative and the IRB on all regulatory issues.
• Provides timely follow-up, issue resolution, update reports and problem escalation as necessary.
• Attends and actively participates in division meetings, sponsor meetings and research meetings, and conferences/in-service education sessions as required. Including but not limited to study Site Initiation Visits and Study Close Out Visits.
• Works as an effective and collaborative team member.
• Serves as a resource for questions related to regulations affecting clinical research, and facilitates resolution of questions through effective communication with internal and external entities.
• 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.
• Reviews and complies with all relevant local, state and Federal laws and regulations.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge,

Skills and Abilities

Required
:

• BA/BS degree in the science/health care field or 2 years related experience.
• Strong attention to detail and customer service focus.
• Excellent communication, organizational,…