Job Opportunity: FSP Clinical Trial Coordinator at Thermo Fisher Scientific
Position Overview
Thermo Fisher Scientific is seeking a FSP Clinical Trial Coordinator I for a remote, full-time position based in India. This role is vital in providing administrative and technical support to project teams within clinical research, ensuring smooth operations and compliance with regulatory standards.
Organization
Company Name: Thermo Fisher Scientific
Location: Work From Home (India)
Position: FSP Clinical Trial Coordinator I
Experience: 1 to 5 Years
Salary: ₹25,000 – ₹35,000 /month
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Job Summary
The FSP Clinical Trial Coordinator I role is integral to the clinical research process, primarily supporting site activation, document processing, and communication between various stakeholders. The position is designed for individuals with a strong background in clinical research coordination and a passion for ensuring audit readiness and regulatory compliance. The role offers the flexibility of working from home while contributing to global clinical trials.
Key Responsibilities
Administrative Support:
- Assist in site activation activities, including document processing and maintaining up-to-date systems like the Electronic Trial Master File (eTMF).
Audit Readiness:
- Ensure all files are reviewed according to Standard Operating Procedures (SOPs), supporting audit readiness and compliance with regulatory requirements.
Communication and Coordination:
- Facilitate effective communication between project teams, coordinate the distribution of study materials, and assist in regulatory submissions.
Data Management:
- Analyze study metrics, reconcile findings, and assist with the clarification and organization of site documentation.
Training and Support:
- Provide training to new staff members and support the maintenance of study-specific documentation and systems.
Feasibility and Site Selection:
- Contribute to the development of site lists and support the local tiering of sites for clinical trials.
Client Interaction:
- Liaise with global investigator services, maintain accounts and contact information, and ensure the timely delivery of documents and materials.
Basic Qualifications and Experience
Education:
- A Bachelor’s degree in Life Sciences is preferred, with a focus on fields such as Pharmacy, Lifesciences, or related disciplines.
Experience:
- 1-3 years of experience in a Clinical Research Coordinator (CRC) or Clinical Trial Coordinator (CTC) role.
Preferred Knowledge, Skills, and Abilities
Business Communication:
- Strong business communication skills are essential for facilitating coordination and collaboration across teams.
Knowledge of eTMF and ICH GCP Guidelines:
- Understanding of eTMF systems and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH GCP) guidelines is crucial for ensuring compliance.
Technical Proficiency:
- Proficiency in Microsoft Office and clinical trial database systems is required.
Organizational and Analytical Skills:
- Strong organizational abilities and attention to detail are necessary for managing multiple tasks and maintaining data accuracy.
Language Skills:
- Effective oral and written communication in English is required for global interactions.
Independent Work:
- Ability to work independently or as part of a team in a fast-paced environment.
Preferred Location
- While this is a remote position, candidates from Mumbai or nearby locations are preferred due to potential on-site training or meetings.
Immediate Availability
- The position requires candidates who are immediately available to join the team and contribute to ongoing clinical trials.
Application Process
Interested candidates are encouraged to apply through the Thermo Fisher Scientific careers portal. This role offers a unique opportunity to work from home while playing a critical role in global clinical research projects. If you have the required experience and a passion for clinical trial coordination, this could be the ideal position for you.
This job posting is tailored to attract experienced professionals in clinical research who are looking for the flexibility of working remotely while contributing to impactful global projects. Join Thermo Fisher Scientific and be a part of a team that is making a difference in the world of clinical research.