Regulatory Affairs Specialist

Join the HJF Team!

HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). This is the second Regulatory Affairs level in the series.

The Regulatory Affairs Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD. The incumbent will be responsible for supporting the compliance of Foundation research programs with applicable local, state and federal regulations for human subject research, animal use research, recombinant DNA, and HIPAA. Moreover, the incumbent will be interfacing with the regulatory counterparts of the SC2i Consortium. The Regulatory Compliance Specialist will support SC2i’s efforts for FDA-regulated clinical studies including working with regulatory consultants.

This position will be in support of the Surgical Critical Care Initiative, USU Department of Surgery.

Responsibilities

• Assists with the review of protocols, grants, contracts, clinical trials, and other research activities to ensure compliance with relevant federal and local regulations and policies of research involving human subjects, laboratory animals, select agents, utilization of recombinant DNA, and HIPAA.
• Serve as regulatory support for Clinical Decision Support Tool (CDST) development and In Vitro Diagnostic (IVD) FDA-regulated clinical trials. Support various clinical trial activities including working with regulatory consultants.
• Assists with maintaining a regulatory database and tracking database to include data entry, queries, and reports.
• Ensures required protocols are registered and up to date in clinicaltrials.gov.
• Reviews research personnel training for assigned portfolio to ensure that participating personnel have received appropriate training in human subjects’ research protection, HIPAA, animal research protection, Good Clinical Practices, conflicts of interest in research, responsible conduct in research, and shipping dangerous goods have been completed.
• Assists with the review of research files to ensure GCPS have been met, informed consent forms have been completed appropriately, and that the principal investigator is maintaining the necessary regulatory files and subject research documents.
• Maintains effective liaison with IRBs, IACUCs, and IBCs where Foundation research is being conducted. Maintains open communication with PIs and research staff in assigned portfolio.
• Maintains updated regulatory files for assigned portfolio. This includes protocols that are less complex. The protocols may have a no greater than minimal risk, minor increase over minimal risk, or greater than minimal risk level.
• Completes regulatory submissions documents for assigned portfolio and ensures they are submitted prior to the deadlines.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Education and Experience

• Bachelor’s Degree is required.
• Minimum of 3-5 years of experience required.

Required Knowledge, Skills and Abilities

• Knowledge of federal and local regulations and policies pertinent to research involving human subjects, laboratory animals, and recombinant DNA, HIPAA.
• Excellent communication and writing skills, interpersonal and organizational skills.
• Must be a self-starter, able to work independently, and able to multi-task.
• Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, cloud-based eRegulatory platforms, and Google suite (gmail, google docs, google sheets, google slides, google drive).
• Regulatory experience supporting FDA-regulated clinical trials is preferred but not required.
• Ability to obtain and maintain a T1/Public Trust background check.

Physical Capabilities

• Ability to stand or sit at a computer for prolonged periods.

Work Environment

• This position will take place primarily in an office setting.

Licenses and Certifications

• Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.

Compensation:

• The annual salary range for this position is $64,200-$80,000. Actual salary will be determined based on experience, education, etc.

Benefits:

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Note: This position requires U.S. citizenship.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.