Regulatory Specialist

Job Title Regulatory Specialist Job Description The Regulatory Specialist promotes compliance with federal regulations, Good Clinical Practice (GCP), and institutional policies for clinical trials. The role serves as a key liaison among investigators, internal departments, institutional review boards (IRBs), and external regulatory agencies to support the safe and compliant conduct of clinical research. The position focuses on managing regulatory documentation, facilitating IRB submissions, and ensuring that all regulatory requirements for clinical studies are met in a timely and accurate manner. Responsibilities Organize and maintain regulatory binders, including filing essential documents and obtaining required signatures for delegation logs, training logs, and other critical study records. Review sponsor template and site-level informed consent forms (ICFs) to ensure compliance with GCP and International Conference on Harmonisation (ICH) guidelines. Participate in the regulatory review, preparation, and submission of clinical study documentation such as investigator brochures, Investigational Device Exemptions (IDE), Investigational New Drug (IND) applications, and treatment or compassionate/emergent use documents. Ensure timely and accurate submission of all protocol amendments, ICFs, investigator brochures, and other administrative items to the IRB of record. Arrange for the receipt and transmission of administrative and regulatory documents, and file Serious Adverse Event (SAE) and IND safety reports as required. Review and interpret IRB correspondence with the research team and promptly notify team members of determinations that may affect the safety and welfare of human subjects. Obtain and maintain updated laboratory and test reference ranges for use in clinical research documentation and review. Update electronic databases to reflect personnel changes and ensure that regulatory records remain current and accurate. Act as a liaison between investigators, sponsors and their representatives, and the IRB on all regulatory issues related to clinical trials. Assist investigators in obtaining necessary system access and approvals to support research readiness and study start-up. Provide timely follow-up on regulatory issues, resolve problems, prepare update reports, and elevate concerns as appropriate. Attend and actively participate in study team meetings, sponsor meetings, research meetings, and conferences or in-service education sessions as required. Prepare regulatory binders and supporting documentation for monitor visits, audits, and site inspections. Perform other work-related duties as assigned in support of the regulatory and clinical research functions. Assist with orienting new staff on their regulatory responsibilities and standard operating procedures. Serve as a resource for questions related to regulations affecting clinical research and provide guidance to colleagues on regulatory requirements. Stay current with developments in GCP and federal regulations regarding clinical research by reading relevant literature, attending training classes, and participating in professional meetings. Maintain overall awareness of the clinical research field and assigned therapeutic or functional areas to support high-quality regulatory oversight. Assist in developing and refining procedures to ensure regulatory compliance across clinical trials. Essential Skills Clinical trial regulatory experience, including direct interaction with institutional review boards (IRBs) and maintaining components of clinical trial conduct. Experience dealing with IRBs, including preparing, submitting, and tracking regulatory documents and correspondence. Demonstrated ability to maintain and manage regulatory documentation, including regulatory binders and essential study documents. Bachelor’s degree (BA/BS) in a science, healthcare, or communications field, or equivalent combination of related education and experience. Strong attention to detail with a commitment to accuracy and compliance in regulatory work. Customer service focus and the ability to support investigators, study teams, and external partners effectively. Excellent communication skills, including clear written and verbal communication with diverse stakeholders. Strong organizational skills with the ability to structure and prioritize work in a regulatory environment. Effective presentation skills for sharing regulatory information and updates with study teams and stakeholders. Solid documentation skills to create, maintain, and audit regulatory records. Strong interpersonal skills to collaborate with investigators, sponsors, IRBs, and internal teams. Ability to work independently and as part of a team while handling multiple deadline-driven tasks in a dynamic environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail for regulatory and administrative tasks. Ability to review and comply with all relevant institutional policies and procedures, as well as local, state, and federal laws and regulations related to clinical research. A few years of regulatory experience in clinical research settings such as hospitals, contract research organizations (CROs), or pharmaceutical companies. Additional Skills & Qualifications Minimum of 3 years of experience in clinical research or a related regulatory area is preferred. Formal education or training in human subjects research and Good Clinical Practice (GCP) is preferred. Knowledge of clinical trial processes and lifecycle, including start-up, conduct, and close-out. Familiarity with basic scientific principles relevant to clinical research and regulatory oversight. Ability to work effectively in a fast-paced environment and manage competing tasks and demands. Experience within an oncology or cancer research setting is beneficial, given the cancer center environment. Interest in ongoing professional development, including reading related literature, attending training classes, and participating in professional meetings. Work Environment This position is based in a cancer center environment that supports a large and growing portfolio of clinical research studies. Approximately 80 professionals are engaged in research activities, with a dedicated regulatory team of about seven people. The role is part of a high-volume, high-pressure, and fast-paced setting where regulatory is one key component of a broader research enterprise. The team culture is described as collaborative and welcoming, particularly toward hardworking colleagues who are eager to contribute. The position follows a hybrid work schedule, typically requiring three days on-site and two days remote each week, with on-site days generally not scheduled back-to-back and not concentrated around Fridays or Mondays. The organization participates in a National Cancer Institute–designated cancer consortium and is expanding its research studies across multiple sites, offering opportunities for growth and advancement, including defined career ladders that support year‑over‑year promotion. The work involves regular use of standard office technologies, including the Microsoft Office Suite, email, and electronic databases, and requires comfort working under deadlines and managing multiple regulatory tasks simultaneously. Job Type & Location Contract to Hire position based out of Hackensack, NJ. Pay And Benefits The pay range for this position is $30.00 - $35.00/hr. Benefits Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type Hybrid position in Hackensack, NJ. Equal Opportunity Employer The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Reasonable Accommodation If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI) We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr