Hackensack, NJ, 07602, USA
21 hours ago
Regulatory Specialist
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. **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. If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! 167603 Starting at $34.65 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.
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