Regulatory Affairs Coordinator

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.; Bethesda (MD); On-site; USD 40,000 - 52,000; Full time

Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

is seeking a Regulatory Affairs Coordinator to support compliance across human subjects research, animal use, recombinant DNA, and HIPAA. Based at the HJF Home Office in Bethesda, MD, the role assists in protocol reviews, database maintenance, and regulatory submissions while collaborating with IRBs and investigators to ensure timely and accurate documentation.

Qualifications

• Bachelor's Degree in a science-related field is required.
• 0-2 years of experience minimum; at least 1 year preferred.
• Knowledge of federal and local regulations related to human subjects, HIPAA, and animal research.
• Strong written and verbal communication and organizational abilities.

Responsibilities

• Assist with review of protocols, grants, contracts, and trials to ensure regulatory compliance.
• Maintain regulatory and tracking databases with data entry, queries, and reports.
• Ensure clinicaltrials.gov registration for protocols.
• Review training for personnel ensuring required protections and shipping compliance.
• Collaborate with IRBs and staff to maintain operational functioning of protocols.
• Monitor regulatory updates from federal agencies.
• Assist with regulatory submissions documents and deadlines.

Skills

Regulatory knowledge

Communication skills

Self-motivation

Multitasking

Organizational skills

Education

Bachelor's Degree in a science related field

Tools

MS Word

Excel

PowerPoint

Access

FileMaker

Adobe Acrobat Pro

E-mail

Job description

Join the HJF Team!

HJF is seeking a Regulatory Affairs Coordinator to be responsible for assisting 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 first level in the Regulatory Affairs series.

This position will be in support of the Clinical Regulatory Affairs & Compliance Office at HJF Home Office in Bethesda, MD.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

• Assists with the review of protocols, grants, contracts, clinical trials and other research activities to ensure compliance with relevant federal and local regulations and polices of research involving human subjects, laboratory animals, select agents, utilization of recombinant DNA and HIPAA.
• 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.
• Maintains effective relationship with research staff, Principal Investigators and Institutional Review Boards' (IRBs) regulatory personnel, and others to ensure continued scientific operational functioning of protocols in assigned portfolio.
• Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
• Review and process research participant travel and reimbursement and request for clincards.
• Assists with completion of documents related to regulatory submissions for assigned portfolio and ensures they are submitted prior to their respective 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 in a science related field required.
• Minimum of 0-2 years of experience required.
• At least 1 year of relevant experience preferred.

Required Knowledge, Skills and Abilities

• Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA, HIPAA.
• Excellent communication and writing skills, interpersonal and organizational skills.
• Must be a self-starter, be 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, and E-mail.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

Physical Capabilities

• Lifting: Requires lifting materials up to 25 lbs.

Licenses and Certifications

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

Work Environment

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

Compensation

• The hourly pay range for this position is $29.33-$38.46. Actual hourly pay 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.

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.