About this role
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.