Regulatory Documents Coordinator I

Are you looking for a rewarding position that can change peoples lives for the better? If so, this extraordinary opportunity is not to be missed.

ICON is recruiting for a Regulatory Documents Coordinator. The position is responsible for preparing and submitting regulatory documents to the sponsor and institutional review board in an accurate and timely manner. In addition the Regulatory Documents Coordinator will provide administrative and clerical support to the management team and other staff members.

Responsibilities:

• Prepares and submits new trial regulatory packets according to instructions from the Sponsor/CRO

• Communicates in a timely manner with Sponsor/CRO and IRB regarding regulatory submission questions.

• Facilitates PI and Manager of Clinical Operations signatures for the Clinical Trial Agreement (CTA)

• Submits any amendments/revisions to the protocol or changes to the consent form and updated advertisements to the IRB as needed.

• Verifies and edits if needed the final approved Informed Consent Form using the PMG Informed Consent Form Checklist. Provides final approved Informed Consent Form with PMG Informed Consent Checklist to the appropriate study coordinator.

• Updates CV's annually for all staff and investigators; obtains updated medical licenses and certificates of insurance for all investigators and licensed PMG staff. Posts all documents including GCP certificates to PMG SharePoint

• Provides support for patient recruitment calls per site needs.

• Assists with training new staff members on regulatory process.

Education/Experience:

• Bachelor's Degree in Life Sciences
• Fluency in English (written/oral)
• Basic clinical research knowledge