Centralized Study Spec I

Fortrea · Bengaluru

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: