Upsilon Global are seeking a freelance/1099 SCRA based in the greater Pittsburgh, Pennsylvania area to assist with the monitoring of US-based drug trial reviewing a treatment administer during cardiac surgery to minimise post-surgical complications.
The sponsor estimates approximately 50 patients to be enrolled at the site, and we're seeking a SCRA with strong experience monitoring ICU and cardiology trials.
Key Study Details:
- Indication: Cardiology/Surgery/ICU
- Start Date: August 2025
- Study Duration: 2 years
- FTE: 0.2-0.4
- Location: Greater Pittsburgh area, Pennsylvania
Key Responsibilities:
- Oversee the Study Start-Up process, ensuring an efficient and timely study initiation.
- Collaborate with cross-functional teams to prepare and submit all necessary documentation for study activation.
- Work with regulatory authorities, ethics committees, and institutional review boards (IRBs) to secure required approvals.
- Ensure compliance with ICH-GCP, FDA regulations, and sponsor requirements throughout the start-up phase.
- Facilitate site activation and ensure sites are fully prepared for patient recruitment.
Study Requirements:
- 5+ years of experience in Study Start-Up roles within clinical trials, with a strong record of successful study initiation.
- Experience in or familiarity with ICU, surgery and cardiology
- In-depth knowledge of U.S. regulatory requirements and clinical trial processes.
- Strong organizational and communication skills, with the ability to manage multiple priorities.
- Ability to work independently, demonstrating initiative, attention to detail, and problem-solving skills.
For more information, please apply or contact [email protected] or call +44 203 875 9966