Regulatory Submission Support Assistant

Position Summary:

The Pre-Review Education Program, commonly called the PREP team, was created within the Research and Education Service of the VA St. Louis Healthcare System to assist Principal Investigators who are in the initial phases of completing their submission packages to the regulatory committees to obtain regulatory approval for their research projects.

The PREP Team Support will work with medical investigators and/or their study team assisting in the preparation of regulatory submission packages, analyzing and editing submission packages, identifying potential problems and finding solutions and assisting in addressing questions from the regulatory committees.

Knowledge, Skills, Abilities:

• Understanding of research enterprise and research administration
• Understanding of review processes
• Decision making skills
• Customer service and diplomacy skills
• Coordinating and collaboration skills
• Displays professionalism in written and oral communication
• Strong organization skills
• Proficient in basic Office Applications including Microsoft Word and Adobe Pro
• Strong oral and written communication
• Ability to conduct training programs/seminars/workshops
• Ability to maintain confidentiality
• Effectively prioritize multiple tasks
• Ability to effectively manage multiple projects simultaneously
• Quickly adapts and implements new policies and procedures

Job Duties and Responsibilities

• Maintain working knowledge of the regulatory process within the VA St. Louis Healthcare System Research and Education Service and their collaborating entities
• Maintain working knowledge of Commercial IRB processes and procedures
• Meets with researchers and/or their study team to discuss their research plans/projects
• Identify all elements required for approval specific to their research plans
• Identify required regulatory documents based on their research plans
• Analyze and revise the submission package for content, grammar, layout and overall completion
• Submit regulatory package to appropriate committees within the appropriate time frames
• Monitors process from start to finish and addresses any issues that arise throughout the process
• Answers questions from researchers and/or their study team relevant to regulatory requirements
• Collaborates with other PREP team members, committee administrators, technology, investigators, research study staff, VREF Executive Director and others
• Presents updates and statuses regarding the regulatory process of research projects
• Answers questions from researchers and/or their study team relevant to regulatory requirements

Qualifications

Required:

• Associates Degree or equivalent experience
• Job is dependent on your ability to meet (and, to continue to meet) ALL employment and access requirements as defined by the U.S. Department of Veterans Affairs (VA). Because these requirements are determined by the VA and outside VREF's control, any job offer may be withdrawn, or employment ended, if VA eligibility or approval is not obtained or maintained.

Preferred:

• Previous experience working in medical research
• Previous experience working with regulatory documents
• Previous experience in communications (writing, editing, etc.)

Job Type: Full-time

Pay: $30.43 per hour

Work Location: In person