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Fortrea
Company Name: Fortrea
Job Title: Centralized Study Specialist I
Job Location: Bengaluru, Karnataka, India
Department: Clinical Research
Industry: Clinical Research / Clinical Trials
Experience Required: 3–5 Years
Qualification: University/ College degree, preferably in Life Sciences, or a relevant allied health profession certification
Job Type: Full-Time
About Fortrea
Fortrea is a global contract research organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies in advancing clinical research and drug development.
Fortrea is hiring for the position of Centralized Study Specialist I in Bengaluru, Karnataka. This opportunity is suitable for clinical research professionals with experience in regulatory documentation, informed consent forms, and clinical trial operations.
Key Responsibilities
- Review and implement study-specific plans and requirements for assigned tasks.
- Support system compliance and perform system data entry, as applicable.
- File required task-related documentation in the Electronic Trial Master File (eTMF).
- Review initial and amended Country/Site Informed Consent Forms (ICFs) in accordance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Coordinate with local teams, Start-up Project Managers, and sponsors to ensure timely approval of Informed Consent Forms and meet submission deadlines.
- Follow applicable departmental Standard Operating Procedures (SOPs) and Work Instructions.
- Complete mandatory training within the required timelines.
- Perform day-to-day tasks while maintaining quality and productivity standards.
- Manage project and technical documentation appropriately.
- Provide administrative and technical support to internal departments and teams.
- Conduct quality checks and ensure the accuracy of completed work.
- Escalate issues promptly and support timely resolution.
- Participate in process improvement initiatives and help implement revised procedures.
- Perform other duties as assigned.
Educational Qualifications
- University or college degree, preferably in Life Sciences.
- Certification in a related allied health profession, such as nursing, medical technology, or laboratory technology, may be considered.
- Relevant equivalent work experience may be accepted in place of formal educational requirements, at Fortrea’s discretion.
Experience and Skills Required
- 3–5 years of experience in clinical research.
- Working knowledge of ICH, FDA, IRB/IEC, and other applicable clinical research regulations and guidelines.
- Experience interacting with operational project teams is preferred.
- Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Access, and Outlook.
- Strong written and verbal communication skills.
- Excellent organizational and proofreading skills.
- Attention to detail and the ability to maintain documentation quality.
Work Environment
The position is based in a general office environment in Bengaluru, Karnataka.
Who Can Apply?
Candidates with 3–5 years of clinical research experience and knowledge of clinical trial documentation, ICF review, eTMF, GCP, and regulatory requirements may be suitable for this opportunity.
How to Apply for Fortrea Careers
Interested and eligible candidates should review the official Fortrea careers portal for the complete job description, eligibility criteria, and application process.
Official Careers Website: https://careers.fortrea.com/
Search for “Centralized Study Specialist I” and select the Bengaluru, Karnataka location to find the relevant opening.
To apply for this job please visit fortrea.wd1.myworkdayjobs.com.
