Centralized Study Specialist I
Fortrea Development India Private Limited · Bengaluru · onsite · Posted 26d ago
Undisclosed3–5 yrsfulltimeSourced from
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About this role
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 (eg, 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.
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Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Technical SupportLIFESCIENCEclinical researchgoogle cloud platformProcess ImprovementEtmfTechnical DocumentationResearchCommunication SkillscomplianceData Entry
About Fortrea Development India Private Limited
Fortrea Development India Private Limited
Clinical Research
3.2k+
employees
2023
3 years old
Bangalore / Bengaluru, Karnataka
India
₹6.8L PA avg
Avg at Fortrea Development India Private Limited
About
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and technology solutions across more than 20 therapeutic areas to the life sciences industry.
Industries
Clinical ResearchBiotech & Life sciencesAnalytics & KPO
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