Aerotek Study Start Up Associate in Hendersonville, Tennessee
• 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 • 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
healthcare, business, administration
Top Skills Details:
time management, multitasking, detail oriented
Additional Skills & Qualifications:
Similar to what we look for with entry level Q-CTA candidates they are looking for high potential candidates that have proven their ability to prioritize, multitask, think independently, stay organized, etc.
They have seen a lot of success hiring pharmacy techs, lab techs, science teachers, EMTs, office/call centers.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
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.