Regulatory Specialist Assistant

POSITION SUMMARY: The Regulatory Specialist Assistant is responsible to apply knowledge of clinical trial operations, Good Clinical Practice (GCP), and ICH guidelines to assure regulatory compliance in all clinical trials conducted at The Indiana Clinical Trials Center’s (ICTC) clinical trial sites.

TYPICAL PHYSICAL DEMANDS: Physically capable of lifting, moving, or transporting supplies, medical records, and equipment within reasonable weight limits. Physically capable of reading and reviewing handwritten chart notations. Physically capable of bending, sitting, or standing for extended periods of time, reaching, and climbing to retrieve or store medical records. Physically capable of manually entering data into an electronic database using a keyboard. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

TYPICAL WORK CONDITIONS: Fast-paced clinical research center environment. Must be able to adjust and adapt to changing conditions.

QUALIFICATIONS, REQUIREMENTS, and EDUCATION: Minimum: High School Diploma.

ESSENTIAL SKILLS:

• Maintains the highest level of professional conduct in the presence of investigators, subjects, research staff, sponsors, etc.
• Computer Literacy: Computer skills with the capability of using clinical trial databases; electronic data capture; Microsoft Word Office, including Word, Excel, PowerPoint, Outlook
• Able to communicate clearly using excellent verbal and written communications skills
• Able to problem-solve, prioritize quickly and accurately, and multi-task to facilitate workflow
• Able to work independently in a fast-paced environment, as well as work collaboratively as a team
• Possess and utilize excellent interpersonal skills with patients, staff, and others
• Meticulous and detail-oriented

DUTIES AND RESPONSIBILITIES:

Regulatory:

• Complete, collect, store, and distribute regulatory documentation required by regulatory agencies, sponsors, and local SOPs.
• Utilizes electronic regulatory platform to route and maintain regulatory documents.
• Troubleshoots and provides system training to users in the electronic regulatory system.
• Communicates with sponsors, monitors, and researchers to ensure all aspects of study compliance.
• Assists with maintaining study personnel certification records (License, CV, GCP).
• Maintains professional relationships and communication with study sites.
• Prepares for study initiation, interim monitoring, and close-out monitoring visits for each location.
• Assisting in completing all study start-up documents.
• Assisting in completing all IRB submissions (initial submission, continuing review, termination reports, protocol deviations, adverse events (AE), serious adverse events (SAE), etc.)
• Assists in facilitating training (i.e., investigator meetings, protocol amendments, pharmacy manual, EDC guidelines, etc.)
• Assists in preparing for IRB submissions, protocol revisions, periodic or final reports, and submitting timely and accurate regulatory documents to sponsors.
• Assist in maintaining Master File with copies of all IRB communications for assigned portfolio of studies.
• Works with study monitors at site visits to resolve any outstanding issues before the end of the site visit
• Any other duty which may be assigned to ensure all regulatory documentation occurs in a timely and thorough manner
• Under the direction of the Regulatory Administrator, will help maintain DOAs, prepares IRB submissions, protocol revisions, etc.