CRA I – FSP Role at Thermo Fisher Scientific; pharmacy graduate eligible
A Thermo Fisher CRA I opportunity has emerged for experienced Clinical Research Associates in Mumbai, Mahārāshtra, India. Thermo Fisher Scientific is seeking qualified candidates for the position of CRA I – FSP, offering a full-time role within their clinical research team. Interested applicants should apply before the deadline.
About the Company
Thermo Fisher Scientific is a leading global contract research organization (CRO) specializing in clinical research services. The company is dedicated to advancing scientific and clinical expertise to facilitate the development of drugs that address significant health challenges. With a robust portfolio, Thermo Fisher Scientific is at the forefront of delivering innovative solutions in the healthcare sector.
- Job Id: R-01368661
- Job Type: Full time
- Category: Clinical Research
- Location: Mumbai, Mahārāshtra, India
- Work Schedule: Standard (Mon-Fri)
- Environmental Conditions: Office
Thermo Fisher CRA I Job Description
Summarized Purpose: In this Thermo Fisher CRA I role, the candidate performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects’ rights, well-being, and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites.
Key Responsibilities
- Monitors investigator sites using a risk-based monitoring approach.
- Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and determine corrective and preventive actions.
- Ensures data accuracy through Source Data Review (SDR) and Source Data Verification (SDV).
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Maintains regular contact between monitoring visits with investigative sites to confirm protocol compliance and resolution of previously identified issues.
- Conducts monitoring activities in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Shares responsibility with other project team members for issue and finding resolution.
Thermo Fisher CRA I Eligibility Criteria
- Master’s degree in a life sciences-related field (preferably Pharmacy).
- 1 to 2 years of independent Onsite Clinical Monitoring experience is mandatory.
- Hands-on experience in conducting site visits to conduct clinical trials across India.
- Experience in monitoring oncology trials is preferred.
Required Skills
- Basic medical and therapeutic-area knowledge.
- Understanding of medical terminology.
- Good oral and written communication skills.
- Ability to manage Risk-Based Monitoring concepts and processes.
- Good organizational and time-management skills.
- Ability to work independently or as part of a team.
- Good computer skills, including solid knowledge of Microsoft Office.
- Good English-language and grammar skills.
How to Apply
Interested candidates can apply through the following link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Conclusion
The Thermo Fisher CRA I position provides a platform for qualified candidates to contribute to impactful clinical research. Interested individuals are encouraged to apply at the earliest before the deadline to secure their chance in this vital role.
