The CTA II/III is a highly-skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the CTA II/III independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities.
- Ensure compliance with protocol and overall objectives across all investigator sites
- Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
- Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
- Execute study activities according to study protocol, regulatory guidelines and operational plan
- Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
- Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
- Participate in study start-up, conduct and closeout activities
- Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
- Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
- Assemble and distribute regulatory binders to clinical sites
- Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
- Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers.
- Assist with preparation and distribution of investigator site contracts and budgets
- Maintain the Trial Master File for all clinical projects
- Bachelor’ s Degree in health sciences related field, RN, or related discipline required
- Minimum 2-5 years relevant experience
- Excellent written and verbal communication skills
- Strong PC skills (MS Word, MS Excel, MS Project)
- Sound analytical and problem-solving skills
- Act with consistent sense of urgency with acute attention to detail.
- Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
- Exceptional organizational and time management skills