Hackensack Meridian Health · 22 hours ago
Regulatory Specialist
Hackensack, NJ
Full-time
Onsite
Entry, Mid Level
$34.65/hr - $34.65/hr
2+ years expHackensack Meridian Health is dedicated to transforming healthcare and serving as a leader of positive change. The Regulatory Specialist is responsible for ensuring compliance with regulations and serves as a liaison for internal and external stakeholders throughout the clinical trial lifecycle.
Assisted LivingHealth CareHealth DiagnosticsHospitalMedical
Responsibilities
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 International Conference on Harmonization (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, Investigational Device Exemption (IDE), Investigational New Drug (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/finance specialist - clarify `task lists' and `assigns 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
Qualification
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, presentation, documentation, and interpersonal skills
Ability to work independently, and in a team, and handle multiple deadline driven tasks in a dynamic environment is essential
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and/or Google Suite platforms
Certified Clinical Research Professional/CCRP or Certified Clinical Research Associate/CCRA or Certified Clinical Research Coordinator/CCRC or Society of Clinical Research Associates Certification/SoCRA
Preferred
Minimum of 2 years experience in Clinical Research, Regulatory, Auditing or IRB
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
Benefits
Health
Dental
Vision
Paid leave
Tuition reimbursement
Retirement benefits
Company
Hackensack Meridian Health
Hackensack Meridian Health is a health care organization that offers research and medical services.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$36.3MKey Investors
Baldrick's FoundationNational Institutes of Health
2023-11-21Grant
2023-02-24Grant· $3M
2019-05-10Grant· $33.3M
Leadership Team
Robert C. Garrett
Chief Executive Officer
Michael Allen
President, Financial Services Division and CFO
Recent News
bloomberglaw.com
2026-01-20
2025-12-15
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