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.
- 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
- Adheres to the standards set forth in the Medical Center’s Employee Handbook.
- 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 HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.
Knowledge, Education and Skills Preferred:
- 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.
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.