Regulatory and Start Up Specialist (Fully Remote)

Precision for Medicine; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Precision for Medicine, a global Clinical Research Organization, seeks a regulatory and site-startup professional to support clinical trials in the United States. The role focuses on submissions, regulatory interactions, and site activation activities across oncology and rare diseases.

You will collaborate with cross-functional teams, ensure TMF readiness, and maintain compliance with local laws while delivering timely updates to project and regulatory leads.

Responsibilities

• Prepare and submit Clinical Trial Application Forms and submission dossiers.
• Interact with Competent Authorities and Ethics Committees for approvals.
• Manage collection of essential documents for site activation.
• Customize Patient Information Sheets and Informed Consent Forms.
• Partner with CRAs, feasibility, and contracts teams.
• Provide regular updates to project and regulatory leads.
• Maintain knowledge of local clinical trial laws.
• Ensure audit/inspection readiness and TMF filing.

Job description

• Prepare and submit Clinical Trial Application Forms and submission dossiers.
• Interact with Competent Authorities and Ethics Committees for approvals.

Site Startup:

• Manage collection of essential documents for site activation.
• Customize Patient Information Sheets and Informed Consent Forms.
• Partner with CRAs, feasibility, and contracts teams.
• Provide regular updates to project and regulatory leads.

Compliance:

• Maintain knowledge of local clinical trial laws.
• Ensure audit/inspection readiness and TMF filing.

Precision for Medicine

Precision for Medicine is a global Clinical Research Organization that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics, and a passion for rare diseases and oncology. The company values growth and innovation, fostering a collaborative and inclusive environment.