Centralized Study Spec I

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 .