Regulatory Specialist Jobs in Hackensack at Hackensack Meridian Health

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 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.

Responsibilities

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

 

• 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 compliance.
• Adheres to the standards set forth in the Medical Center's Employee Handbook.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• 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 HUMC and Business Unit policies and procedures, and local, state, and Federal laws and regulations.

Education, Knowledge, Skills and Abilities 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.

Licenses and Certifications Preferred:

• Certified Clinical Research Professional.
• Certified Clinical Research Coordinator.
• Certified Clinical Research Associate.

 

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

Compensation
Minimum rate of $35.17 Hourly

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.

HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER

All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.

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.