Regulatory Specialist

Hackensack Meridian Health; Neptune City (NJ); Sur place; USD 40 000 - 57 000; Plein temps

Résumé du poste

Hackensack Meridian Health is seeking a Regulatory Specialist to ensure compliance with GCP, FDA/IRB regulations, and institutional policies across clinical trials. The role liaises with investigators, sponsors, IRBs, and regulatory bodies, coordinating audits and study documentation throughout the lifecycle.

The ideal candidate has a science/healthcare background or relevant regulatory experience, strong communication, and organization skills, with proficiency in MS Office and Google Suite.

Qualifications

• BA/BS in science or healthcare or 2+ years related experience with GED.
• Strong attention to detail and customer service focus.
• Excellent communication, organizational, presentation, and interpersonal skills.
• Ability to work independently, and in a team, and handle multiple deadline driven tasks.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and/or Google Suite.

Responsabilités

• Organizes and maintains regulatory binder in audit ready condition.
• Reviews sponsor templates and ICFs for GCP/ICH compliance.
• Provides access to updated protocol and related documents via electronic process.
• Tracks changes to informed consents and sends to sponsor for IRB review.
• Facilitates regulatory submission of study documentation as required.
• Ensures timely submission of protocol continuing reviews, amendments, and ICFs to IRB.
• Updates regulatory documents and Oncore task lists.
• Acts as liaison between investigators, sponsors, and IRB.

Connaissances

Attention to detail

Customer service

Communication

Organizational skills

Teamwork

Formation

BA/BS in science or healthcare

GED or high school diploma with related experience

Outils

Microsoft Office Suite

Google Suite

Description du poste

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 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 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 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 sends 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.
• Ensures the accurate updating and maintenance of regulatory documents pertaining to the DSMB, Biosafety Committee, and the Protocol Review Committee, when applicable.
• 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 all relevant electronic databases including, but not limited to, any personnel changes and study status changes related to assigned clinical trials 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, updates 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 experts.
• 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 2 or more years of experience in a related area with High School diploma, general equivalency diploma (GED), and/or GED equivalent programs.
• 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.

Education, Knowledge, Skills and Abilities Preferred:

• Minimum of 2 or more years of extensive experience in research that includes Clinical Research, Regulatory, Auditing, and interactions with an IRB.
• Education on human subject research and GCP.

Licenses and Certifications Preferred:

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

Starting Minimum Rate

Minimum rate of $35.17 Hourly

Job Posting Disclosure

HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant work experience. Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.