Eccentric Clinical Research: Clinical Trial Assistant – Gandhinagar
Job Summary:
Eccentric Clinical Research is seeking a highly motivated and detail-oriented Clinical Trial Assistant (CTA) to join our growing team in Gandhinagar. This entry-level position offers an exciting opportunity for recent graduates and early-career professionals to gain hands-on experience in the dynamic field of clinical research. As a CTA, you will play a crucial role in supporting clinical trial operations, ensuring compliance with Good Clinical Practice (GCP) guidelines, and contributing to the advancement of medical knowledge. If you’re passionate about clinical trials, regulatory documentation, and eager to build a career in clinical research, we encourage you to apply!
About Eccentric Clinical Research:
Eccentric Clinical Research is a forward-thinking Contract Research Organization (CRO) dedicated to providing high-quality clinical research services. We pride ourselves on our commitment to excellence, ethical conduct, and continuous innovation. By joining our team, you’ll be part of a collaborative and supportive environment where your contributions are valued, and your professional growth is encouraged.
Key Responsibilities:
As a Clinical Trial Assistant, you will be responsible for providing administrative and operational support to clinical trial teams. Your responsibilities will include:
- Trial Master File Management: Assist in the preparation, maintenance, and updating of the Trial Master File (TMF/eTMF), ensuring all essential documents are properly filed, version-controlled, and archived.
- Regulatory Submissions: Support the preparation, submission, and tracking of regulatory and ethics committee documents, ensuring timely and accurate submissions.
- Study Setup and Monitoring: Assist Project Managers and Clinical Research Associates (CRAs) with study setup, feasibility assessments, site initiation visits, monitoring activities, and study close-out procedures.
- Project Tracking and Reporting: Track project progress using dashboards, trackers, and reports, providing regular updates to the study team.
- Communication and Coordination: Coordinate site payments, facilitate communication with investigators, and manage vendor relationships.
- Clinical Trial Supplies: Manage the shipment, distribution, and tracking of clinical trial supplies to ensure timely availability at study sites.
- Database Management: Maintain accurate and up-to-date investigator and vendor databases.
- Compliance and Quality Assurance: Ensure compliance with Standard Operating Procedures (SOPs), ICH-GCP guidelines, and local regulatory requirements.
- Audit and Inspection Support: Support audits and inspections, assist with Corrective and Preventive Action (CAPA) documentation, and contribute to safety reporting activities, including Serious Adverse Event (SAE) tracking.
- Process Improvement: Participate in departmental initiatives and contribute to process improvements to enhance efficiency and quality.
- Career Development: Gain hands-on experience and mentorship to progress into CRA roles and advance your career in clinical research.
Required Qualifications & Skills:
To be successful in this role, you should possess the following qualifications and skills:
- Education: Bachelor’s degree in Life Sciences, B.Pharm, or M.Pharm.
- Experience: 0–2 years of experience in clinical research (fresh graduates with strong academics or relevant internships are encouraged to apply).
- Knowledge: Understanding of clinical trial processes, GCP guidelines, and regulatory requirements.
- Skills:
- Strong communication, documentation, and organizational skills.
- Proficiency in MS Office applications (Word, Excel, PowerPoint).
- Ability to work effectively with clinical trial tools and software.
- Ability to multitask, prioritize tasks, and work in a fast-paced environment.
- Attention to detail and a commitment to accuracy.
- Attributes: Proactive, adaptable, and a team player with a strong work ethic.
Why Join Eccentric Clinical Research?
- Growth Opportunities: Work with a rapidly growing CRO and gain valuable real-world exposure to the clinical research industry.
- Career Advancement: Fast-track your career toward CRA and Clinical Operations roles with structured training and mentorship.
- Global Exposure: Opportunity to work on global-standard clinical studies, gaining experience in international clinical research practices.
- Mentorship and Learning: Learn from experienced CRAs and project managers, benefiting from their expertise and guidance.
- Supportive Culture: Be part of a supportive work culture that values continuous learning, collaboration, and employee well-being.
Location:
Gandhinagar, Gujarat – India
How to Apply:
If you are interested in this exciting opportunity, please submit your updated CV to [email protected].