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 Senior Regulatory Specialist is responsible for the oversight and management of clinical trial regulatory for all assigned clinical trials and serves as a primary contact for investigators and research team throughout the life of the study. This role will oversee and coordinate ancillary service department reviews for each protocol as well as troubleshoot and assist with delays related to collaborating divisions, departments and institutions, the Institutional Review Board (IRB) and external regulatory agencies. This role is responsible for ensuring compliance with Federal, State, and Local Regulations, Good Clinical Practice (GCP), and Institutional policies and procedures as it relates to all regulatory aspects of assigned clinical trials conduct. 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 for all regulatory matters concerning all assigned clinical trials 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.

Responsibilities

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

• Assists with the management and oversight for all clinical investigators Good Clinical Practice and Human Subjects Training certification documents and medical licenses. This includes: a. Collaborates with nurse educators on maintaining current GCP and Human Subjects training certification documents for clinical investigators as well as medical licenses. b. Maintains central access and dissemination of current certifications and medical licenses to the regulatory team. c. Updates certification copies as needed, in collaboration with the nurse educator.
• Serves as the primary point of contact for all Regulatory related inquiries, both internally and externally.
• Assists with the preparation of regulatory documents for internal or external audits or inspections that are forthcoming.
• Onboards newly hired research personnel within the Regulatory team and external team members:
  • Develops onboarding training materials related to the regulatory process and responsibilities for newly hired team members.
  • Provides guidance and oversight throughout the duration of the onboarding process for all newly hired regulatory staff.
  • Provides updates and recommendations to Regulatory Manager regarding onboarding of all newly hired personnel, including extending onboarding and training when needed
  • Provides overview of regulatory requirements via a powerpoint presentation to newly hired research staff working in areas outside of regulatory.
• Assists the regulatory manager in developing processes and procedures to help ensure regulatory compliance.
• Assists the Regulatory Manager in ensuring that coverage of studies for Regulatory Specialist staff on extended leave is allocated appropriately.
• Assists the Regulatory Manager in obtaining and maintaining updated lab/test ranges.
• Assists the Regulatory Manager in the dissemination of new internal workflows, policies and procedures to improve efficiency and work performance within the division.
• 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
• Ensures 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.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• BA/BS diploma/degree in science or healthcare field OR minimum of 4 or more years of experience in a related area with High School diploma, general equivalency diploma (GED), and/or GED equivalent programs.
• Minimum of 2 years experience as a Regulatory Specialist, or at least 4 years related experience in the field of clinical research regulatory matters
• Strong attention to detail and customer service focus.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Excellent organizational, presentation, documentation and interpersonal skills.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Education, Knowledge, Skills and Abilities Preferred:

• Minimum of 4 or more years of extensive experience in research that includes clinical trial regulatory activities.
• Education on human subject research and GCP.

Licenses and Certifications Preferred:

• Certified Clinical Research Administrator or Certified Clinical Research Professional or Society of Clinical Research Associates Certification.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

Our Network

Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility

As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.