Fortrea—Centralized Study Spec I

Job description

Description: Summary of Responsibilities: - Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks - Support system compliance and system data entry, as applicable - File required task-related documentation in the Electronic Trial Master File (eTMF) - Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines. - Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines. To follow all applicable departmental Standard Operating Procedures and Work Instructions: - To complete required trainings according to required timelines. - To complete day-to-day tasks ensuring quality and productivity. - To manage project and technical documentation in an appropriate manner. - To provide administrative and technical support to internal departments and teams as needed. - To perform checks to ensure quality of work completed. - To ensure timely escalation and issue resolution as needed. - To participate in process improvement opportunities and assist with the implementation of revised processes and procedures. - All other duties as needed or assigned. Qualifications (Minimum Required): - University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) - Fortrea may consider relevant and equivalent experience in lieu of educational requirements Experience (Minimum Required): - Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. - 3-5 years' work experience in clinical research - Previous interaction with operational project teams preferred. Preferred Qualifications Include: • Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services) • Good written and oral communication skills • Well-developed organizational skills • Excellent proof-reading skills Physical Demands/Work Environment: - General Office Environment. Learn more about our EEO & Accommodations request here.