Regulatory Associate: IRB Submissions & Trial Compliance

Charter Research, LLC; Orlando, Northern (FL, KY); Hybrid; USD 50,000 - 75,000; Full time

Job summary

Charter Research, LLC in Orlando, FL is seeking a Regulatory Associate to manage regulatory packets for clinical trial protocols and coordinate IRB submissions. The role emphasizes accuracy, timely updates, and collaboration with clinical operations and sponsors.

Responsibilities include preparing regulatory documents, reviewing informed consent forms, tracking approvals, maintaining audit-ready files, and supporting quality assurance audits. Prior clinical research experience is preferred.

Qualifications

• Ability to handle multiple tasks/projects simultaneously.
• Exceptional planning/organizational skills and attention to detail.
• Strong verbal and written communication skills.
• Ability to work well independently and as part of a team.
• Must possess a high degree of integrity and ability to handle confidential information appropriately.

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.

Education

Clinical research experience

Job description

Charter Research, LLC in Orlando, FL is seeking a Regulatory Associate to manage regulatory packets for clinical trial protocols and coordinate IRB submissions. The role emphasizes accuracy, timely updates, and collaboration with clinical operations and sponsors.

Responsibilities include preparing regulatory documents, reviewing informed consent forms, tracking approvals, maintaining audit-ready files, and supporting quality assurance audits. Prior clinical research experience is preferred.