Job description

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

Preferred: Previous experience working in medical research

Previous experience working with regulatory documents

Previous experience in communications (writing, editing, etc.)

*Salary commensurate with experience*

Job Type: Full-time

Pay: $28.48 per hour

Schedule:

• Monday to Friday

Experience:

• Research: 1 year (Preferred)

Work Location: In person

offroadmanagementgroup.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, offroadmanagementgroup.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, offroadmanagementgroup.com is the ideal place to find your next job.