Description: Study Start Up Associate
• 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 making Covance ready 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
• 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
health care, business, administration
Top Skills Details:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.