Regulatory Liaison

Alliance For MultiSpecialty Research LLC•Knoxville, TN

5d•Onsite

About The Position

The role of the Regulatory Liaison performs a wide variety of clerical and administrative tasks to support the on-site team. This role ensures all study related activities are completed accurately and in their entirety. To consistently embody AMR Clinical’s Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Regulatory Liaison reports to the Site Manager. Classification: Non-Exempt

Requirements

At least one year of clinical research experience.
Ability to learn and become proficient in various web-based programs.
Devote keen and acute attention to detail
Willingness to work in an evolving fast paced environment.
Ability to operate basic office equipment including but not limited to copy machines, facsimile machines and computers.
Strong verbal and written communication skills
Ability to work independently
Strong interpersonal skills
Positive, collaborative, team mentality
Excellent task management and prioritization skills
Build and cultivate long term relationships
Excellent follow up
Drive and initiative
Fluent in English

Nice To Haves

Clinical conductor experience preferred

Responsibilities

Track and maintain Essential Documents for each study in compliance with FDA, GCP, and sponsor requirements.
Ensure all regulatory binders are accurate, complete, and audit-ready at all times.
Assist in preparing sites for audits and regulatory inspections, ensuring documentation is up to date.
Facilitate the resolution of pending regulatory action items to ensure compliance and timely completion.
Coordinate with study coordinators, investigators, and central regulatory teams to ensure compliance with regulatory timelines.
Provide training support to site staff on regulatory documentation and compliance procedures.
Facilitate remote and on-site monitoring sessions, addressing document requests in real-time.
Provide high quality service to sponsors, CROs, IRBs and subjects in a timely manner
Clerical duties relating to the conduct of the clinical trials
Consistent communication with team members on the needs of regulatory matters.
Create and maintain training logs including all signatures of delegated staff.
Maintain DOA and training logs
Maintain SIV signature logs
Maintain list of team members credentials and their expiration dates.
Enter data into system as appropriate.
Maintain study specific training and education for each team member, if a
Assist monitors during on-site visits.
Stock monitor rooms as needed.
Certificates may be added to paper regulatory, Complion or Veeva.
Assist the central regulatory team as needed.
Assist the study launch team as needed
Complete and maintain trainings as required
Position may require occasional weekend and/or overtime hours.
Other duties as assigned