Centralized Study Spec I

Fortrea; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Fortrea in Bengaluru is seeking a Clinical Research Support professional to help review study plans, manage eTMF documentation, and ensure regulatory compliance across trial activities.

You will coordinate with local teams and sponsors to secure informed consent approvals, perform quality checks, and contribute to process improvements while maintaining strict SOP adherence.

Qualifications

• ICH/GCP FDA/IRB/IEC regulatory knowledge expected.
• 3–5 years of clinical research experience.
• Experience with informed consent forms and site/start-up processes.

Responsibilities

• Review and implement study plans and required tasks for assigned trials.
• Support data entry and system compliance in eTMF and related systems.
• Coordinate with local teams, project managers, and sponsors to secure timely approvals.
• Ensure quality via checks, documentation, and adherence to SOPs/WIs.
• Escalate issues promptly and participate in process improvements.

Skills

MS Office

Documentation

Communication

Organizational skills

Quality checks

Education

Life science degree

Nursing certification / allied health

Tools

eTMF system

Job description

Summary of Responsibilities:Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasksSupport system compliance and system data entry, as applicableFile 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 requirementsExperience (Minimum Required):Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.3-5 years' work experience in clinical researchPrevious 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 skillsPhysical Demands/Work Environment:General Office Environment.Learn more about our EEO & Accommodations request here .