Regulatory Associate — Clinical Trials & IRB Submissions

Charter Research; Orlando (FL); On-site; USD 55,000 - 75,000; Full time

Job summary

Charter Research, based in The Villages and Orlando, FL, seeks a Regulatory Associate to prepare regulatory packets, maintain regulatory files, and facilitate IRB submissions for multiple trials. This role requires meticulous document control and timely collaboration with sponsors and IRBs.

You will track submission status, review consent forms, ensure audit-ready documentation, and support audits and regulatory training in a fast-growing environment.

Qualifications

• Ability to handle multiple tasks/projects simultaneously.
• Excellent planning and organizational skills with attention to detail.
• Strong verbal and written communication skills.
• Ability to work independently and as part of a team.
• High integrity and ability to handle confidential information.

Responsibilities

• Prepare regulatory documents for new study submissions to the IRB and sponsor.
• Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.
• Review Informed Consent Form (ICF) drafts and incorporate suggested revisions in alignment with clinical operations, the IRB, and sponsor.
• Inform clinical operations of new IRB approvals including initial approval, protocol amendments, consent forms, and other subject-facing materials. Provide guidance regarding implementation and training requirements.
• Verify protocol training is completed prior to assigned team members completing the Delegation of Authority (DOA) logs.
• Maintain regulatory files in an “audit-ready” status at all times by ensuring documentation and filings are up to date.
• Meet with study monitors during interim monitoring visits to ensure resolution of outstanding regulatory document issues within an appropriate time frame.
• Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.
• Track IRB approval expiration dates and submit continuing review reports to the IRB prior to the deadline to avoid lapses in approval.
• Communicate with study sponsors regarding any revised site information and notify the IRB as required.
• Receive, track, and distribute Investigational New Drug (IND) Safety Reports to the Principal Investigator for acknowledgement of review and file.
• Ensure all regulatory books are updated at final monitoring closeout visits and notify the IRB of closure.
• Prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.
• Maintain documentation of staff credentials and qualifications (e.g., CVs, licenses, GCP) and facilitate updates and / or renewal as required.
• Perform ad-hoc projects and/or general office duties as requested.

Skills

Multitasking

Planning & Organization

Verbal & Written Communication

Independence & Teamwork

Integrity & Confidentiality

Job description

Charter Research, based in The Villages and Orlando, FL, seeks a Regulatory Associate to prepare regulatory packets, maintain regulatory files, and facilitate IRB submissions for multiple trials. This role requires meticulous document control and timely collaboration with sponsors and IRBs.

You will track submission status, review consent forms, ensure audit-ready documentation, and support audits and regulatory training in a fast-growing environment.