Come Work at HJF!
HJF is seeking a Site Regulatory Affairs Coordinator to support the Infectious Disease Clinical Research Program (IDCRP) at the Madigan Army Medical Center (MAMC) working 24 hours/week. HJF provides scientific, technical and programmatic support services to IDCRP.
- Maintains effective relationship with Principal Investigators, Program Administrators, and Institutional Review Boards (IRBs) regulatory personnel, and others to ensure the continued scientific operational functioning of the organization at Department of Defense (DoD) Medical Treatment Facility (MTF) sites where IDCRP research is being conducted.
- Completes site protocol templates, memos, and other documents related to regulatory submissions and continuing reviews. Ensures site-specific IRB submissions, reports and continuing reviews are submitted prior to their respective deadlines.
- Reviews site study team’s determinations and documentation of protocol deviations, violations, and safety-related events (AEs, SAEs, etc.) and reports accordingly. Responsible for submitting events to the USU ID IRB, local IRB, and study Safety Monitoring group (as applicable).
- Maintains and distributes protocols and study documents. Maintains regulatory binders for all studies at the site and ensures local documents are posted to the IDCRP intranet. This includes updated CV’s, SOE’s, COI’s, Researcher Responsibility forms, required trainings for local study personnel, and site personnel list.
- Acts as Regulatory liaison between study team and local regulatory agent/IRB/Command to ensure the adherence to local regulatory requirements and responsibilities as outlined by MOU and local IAIR. Serves as the POC between Site IRB/DCI/CID Command and IDCRP and is instrumental in ensuring local requirement awareness and adherence.
- Creates and maintains site SOPs and other regulatory operational documents.
- Prepares research training activities for principal investigators and research personnel. Tracks research training activity and ensure that the regulatory database and the regulatory binders are current at all times.
- Serves as local subject matter expert on electronic IRB system for both USU ID IRB and local IRB. Ensures local staff have accounts and are trained on system.
- Assists with study specific Quality Management reviews. Implements quality management plans and manages regulatory documents. Conducts periodic QA reviews as required per protocol.
- Provides human subject monitoring support for the program. Coordinates and provides support for auditing, institutional monitoring, and inspection by authorized regulatory bodies.
- Maintains contacts information relevant to IDCRP operation, publications, presentations, abstracts, and other works. Manages submissions of authored works to internal and external reviewing authorities (local command, USU, journals, etc.).
- Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
- Provides support to IDCRP network regulatory efforts through participation in special projects and regulatory working groups.
- May provide editorial reviews for research staff, administrative support such as typing, copying, proof reading, filing and archiving study related documents
- May assist with recruitment, data collection, data entry and clinical research coordination activities for IDCRP protocols.
- Other duties as required.
Required Knowledge, Skills, and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects; excellent communication, interpersonal and organizational skills; ability to utilize computer applications packages, such as MS Word, Excel,
Minimum Education/Training Requirements: Bachelor’s degree in a scientific discipline or a related field is desired. Must have completed training in human subjects protection in research.
Minimum Experience: 1–2 years-related experience in the area of human use and clinical research. Experience in a medical or scientific environment is preferred.
Physical Capabilities: Must be able to utilize computer for lengthy periods; perform routine filing; standing for lengthy periods of time utilizing Xerox machine for copying documents; must be able to travel to local sites occasionally.
Work Environment: Office environment. Local travel can be anticipated about 5% of the time.
Background Requirements: US Citizen; Ability to obtain Secret Clearance.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.