Regulatory Compliance Specialist- Clinical Trials (Full-time or Part-time)

Overview

Join the HJF Team!

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HJF is seeking a Regulatory Compliance Specialist - Clinical Trials to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, genomics / proteomics, and Health Insurance Portability and Accountability Act (HIPAA).

This position will be in support of the Surgical Critical Care Initiative, USU Department of Surgery. The Surgical Critical Care Initiative (SC2i), funded by the Department of Defense, was established in 2013.

SC2i is a Uniformed Services University center that leverages legacy information from service members, and critically ill civilian and military patients to develop biomarker-driven clinical decision support tools (CDSTs) with the goal of improving patient clinical outcomes and reducing costs across the injury / disease cycle.

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.

Responsibilities

• Leads the review of protocols, regulatory documentation, and other research activities to ensure compliance with relevant federal and local regulations and policies regarding research involving human subjects, laboratory animals, select agents, the use of multi-omics, and HIPAA.
• Maintains a regulatory and tracking database, including data entry, queries, and reports. Collaborates with research staff, Principal Investigators, and Institutional Review Boards to prepare, submit, and obtain approval for new research protocols and relevant agreements.
• Maintains the department's research protocols and agreements, including all correspondence, and preparing and distributing reports related to the protocols.

Works directly with various HJF Headquarters departments on preparation of data sharing / use agreements, material transfer agreements, CRADAs, etc.

• Provides necessary information for the protocols, such as clearance forms, data forms, rosters, and more. Additionally, prioritizes all administrative tasks to ensure that protocols are expedited in a timely manner.
• Maintains effective relationships with research staff, Principal Investigators, Institutional Review Board (IRB) regulatory personnel, SC2i consortium regulatory counterparts, and other key stakeholders to ensure the continued scientific and operational functioning of protocols within the assigned portfolio.
• Leads efforts in managing compliance and regulatory issues, and in preparing for research training activities for Principal Investigators and research personnel.
• Serves as regulatory support for the development of Clinical Decision Support Tools (CDST) and In Vitro Diagnostic (IVD) FDA-regulated clinical trials.
• Supports various clinical trial activities, including collaboration with regulatory consultants to ensure compliance with regulatory requirements.
• Prepares and manages all regulatory documentation for FDA submissions, including conducting pathway analyses and preparing Q-Submissions, Pre-IDE, and IDE applications, as well as other necessary documentation to facilitate the FDA approval process.
• Please note, this role is distinct from clinical trial operations and does not involve tasks typically associated with Clinical Research Coordinators (CRCs) or trial nurses, such as patient enrollment or study documentation related to clinical trial execution.
• 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.

Qualifications

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 subject, laboratory animals and genomics / proteomics, HIPAA;

excellent communication and writing skills, interpersonal and organizational skills.

• Must be a self-starter and be able to work independently; must be able to multi-task; ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat Pro, Google Docs, Google Drive and E-mail.
• Ability to prioritize and manage workload effectively; ability to multi-task effectively; ability to function effectively as part of a team.
• Ability to identify and research problems / issues thoroughly and use discerning judgment in problem solving for organization, management, and scientific issues using a significant degree of qualitative, quantitative and analytical skill.
• Outstanding English writing skills.
• Regulatory experience supporting FDA-regulated clinical trials is necessary. Strong motivation to learn about FDA regulated clinical trial preparation and tracking required.
• Ability to obtain and maintain a T1 / Public Trust background check.

Licenses and Certifications

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

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.
• This position is open to full-time or part-time work.

Note : This work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years.

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

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.

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