CRA I – FSP at Thermo Fisher Scientific | Pharmacy graduates | Apply Online
A rare chance has emerged for aspiring Clinical Research Associates as Thermo Fisher Scientific invites applications for the Thermo Fisher CRA I position in Mumbai, India. This fully remote role offers an opportunity to engage in clinical monitoring and site management processes.
About the Company
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and consumables. The company operates in the life sciences sector, supporting pharmaceutical and biotechnological research and development across the globe. With a commitment to innovation and quality, Thermo Fisher Scientific aims to enable customers to make the world healthier, cleaner, and safer.
Job Details
- Company: Thermo Fisher Scientific
- Job Title: CRA I – FSP
- Location: Mumbai, India
- Remote Type: Fully Remote
- Time Type: Full Time
- Posted On: Posted Today
- Job Requisition ID: R-01368661
- Work Schedule: Standard (Mon-Fri)
- Environmental Conditions: Office
Thermo Fisher CRA I Job Description
In the Thermo Fisher CRA I role, the selected 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. Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.
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.
- Determine corrective and preventive actions.
- Bring sites into compliance.
- Reduce study and site-level risks.
- Ensures data accuracy through:
- Source Data Review (SDR).
- Source Data Verification (SDV).
- Case Report Form (CRF) review, as applicable.
- On-site and remote monitoring activities.
- Assesses investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management promptly and follows issues through to resolution.
- Maintains regular contact between monitoring visits with investigative sites, as needed, to confirm:
- Protocol compliance.
- Resolution of previously identified issues.
- Timely recording of study data.
- Conducts monitoring activities in accordance with the approved monitoring plan.
Eligibility Criteria
- Master’s degree in a life sciences-related field (preferably Pharmacy).
- 1 to 2 years of independent Onsite Clinical Monitoring experience mandated.
- 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.
- Ability to attain and maintain working knowledge of:
- ICH-GCP requirements.
- Applicable regulations.
- Relevant procedural documents.
- Good oral and written communication skills.
- Ability to communicate effectively with medical personnel.
- Good interpersonal skills.
- Strong customer focus demonstrated through:
- Effective listening.
- Attention to detail.
- Ability to identify customers’ underlying issues and needs.
- Good organizational and time-management skills.
- Ability to remain flexible and adaptable across a wide range of scenarios.
How to Apply
Conclusion
This Clinical Research Associate I position at Thermo Fisher Scientific presents a valuable opportunity for qualified candidates to contribute to the field of clinical research. Interested individuals are encouraged to apply before the deadline to ensure consideration for this role.
