Study Start Up Associate
Posting ID: 7332146
- Primary contact and liaison with investigative sites during study maintenance and when assigned, site start-up (SSU) activities, with responsibility for collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team.
- Ensure documents are filed and systems are updated on an ongoing and timely basis. Be prepared for an audit at any time.
- Collect and track regulatory & investigator documents required for effective and compliant study site activation and maintenance.
- Ensure that all assigned maintenance and start up activities are on track and support study deliverables.
- Follow up with sites in order to ensure documents required are collected in a timely manner.
- Escalate study issues appropriately and in a timely fashion.
- Update study documents when there are changes in study personnel/study amendments.
- Contribute to the preparation of submissions to IRB/IEC with appropriate supervision.
- Ensure high quality site documents are filed in the TMF in a timely manner according to study plans.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.
- Perform other duties as assigned by management.
- Preferred University/College degree (life science preferred), or certification in related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) or strong work history in the clinical research field.
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process.
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
Recruiter: Taylor Harris
Phone: (704) 329-8151