Regulatory Associate

Johnson County Clintrials•Kansas City, MO

8d•Onsite

About The Position

The Regulatory Associate position is responsible for providing support to the Regulatory Administrator through coordinating and documenting internal regulatory processes, such as internal audits, inspections, license renewals, or registrations across multiple studies. This position collaborates with multiple IRBs, sponsoring companies, and co-workers to ensure study documents receive approval and are made available to the site in a timely manner. The Regulatory Associate will oversee pre-submission to governing agencies and provide foundational information for more complex regulatory work. This position reports to the Regulatory Administrator.

Requirements

Excellent communication, interpersonal, analytical and problem-solving skills
Microsoft Office Suite proficiency
Writing and verbal communication skills
Knowledge of medical terminology and concepts
Proficient typing and data entry skills
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Memory to retain information and know where to research answers
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong analytical, problem solving skills
Self motivated
Must be results oriented, multi-tasking, quick learner
Respond to the urgent needs of the team and show a strong track record of meeting deadlines
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
Previous experience in a clinical research setting or related work environment
Familiarity with or ability to learn clinical trial management system software

Nice To Haves

Bachelor's degree is preferred

Responsibilities

Assist the Regulatory Administrator in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial’s duration for research studies.
Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with the Institutional Review Board (IRB) policies, procedures, and regulations
Responsible for study completion processes including reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical data that has been entered on case report forms or in reports and assuring archival of appropriate/required documentation
Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process
Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies
Monitors, detects, and reports adverse events meeting requirements of regulatory bodies in a timely manner
Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
Completes and maintains regulatory documents for all study personnel, including CVs, licenses, Form FDA 1572, confidentiality agreements, and delegation of duties logs
Reviews initial submissions to determine review category and action to be taken
Compiles and maintains Paper Investigator Site File (ISF) Binders and eISF.
Completes regulatory applications and other required documentation, prepares protocol specific forms for submission to various review committees, including review boards, the IRB, and sponsors
Supports the Regulatory Administrator and VP of Study Operations in the day-to-day activities of regulatory safety management for patients enrolled on research protocols
Completes protocol renewal applications, amendment applications, and maintains records of all adverse event reports
Attends research team meetings to report on regulatory issues
Assists Regulatory Administrator in creating and maintaining protocol specific training documents
Communicates with CRA at on-site and/or remote monitoring visits and assists with necessary regulatory tasks
Other duties as assigned