Regulatory Associate

2 weeks ago

Orlando FL United States Charter Research Full time

COMPANY DESCRIPTION

Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in Orlando.


POSITION OVERVIEW

The Regulatory Associate is responsible for processing regulatory packets and documents for each clinical trial protocol, maintaining regulatory files, and facilitating Institutional Review Board (IRB) submissions.


RESPONSIBILITIES

  1. Prepare regulatory documents for new study submissions to the IRB and sponsor.
  2. Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.
  3. Review Informed Consent Form (ICF) drafts and incorporate suggested revisions in alignment with clinical operations, the IRB, and sponsor.
  4. 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.
  5. Verify protocol training is completed prior to assigned team members completing the Delegation of Authority (DOA) logs.
  6. Maintain regulatory files in an “audit-ready” status at all times by ensuring documentation and filings are up to date.
  7. Meet with study monitors during interim monitoring visits to ensure resolution of outstanding regulatory document issues within an appropriate time frame.
  8. Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.
  9. Track IRB approval expiration dates and submit continuing review reports to the IRB prior to the deadline to avoid lapses in approval.
  10. Communicate with study sponsors regarding any revised site information and notify the IRB as required.
  11. Receive, track, and distribute Investigational New Drug (IND) Safety Reports to the Principal Investigator for acknowledgement of review and file.
  12. Ensure all regulatory books are updated at final monitoring closeout visits and notify the IRB of closure.
  13. Prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.
  14. Maintain documentation of staff credentials and qualifications (e.g., CVs, licenses, GCP) and facilitate updates and / or renewal as required.
  15. Perform ad-hoc projects and/or general office duties as requested.


KNOWLEDGE, SKILLS, AND ABILITIES

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


QUALIFICATIONS

Education

  1. Associate’s degree required. Bachelor’s degree preferred.

Experience

  1. 1 year of clinical research experience preferred.


PHYSICAL REQUIREMENTS

  1. Prolonged periods of sitting at a desk and working on a computer.
  2. Prolonged periods of standing, bending, and reaching.


Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.

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