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.

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.

• 2 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

Learn more about our EEO & Accommodations request here.