Are you passionate about clinical research and operations? Samahitha Research is currently hiring for the position of Clinical Trial Assistant (CTA) in Bengaluru, Karnataka. This opportunity is perfect for candidates with 3 months to one year of experience who are ready to make an immediate impact in clinical trial operations.
About Samahitha Research
Samahitha Research is a respected name in the clinical research industry, known for its commitment to excellence and adherence to the highest standards of regulatory compliance. Our focus is on fostering innovation and supporting groundbreaking clinical trials to advance medical knowledge and patient care. Joining our team means being part of a collaborative environment where your skills and dedication contribute to the success of impactful projects.
Job Designation: Clinical Trial Assistant (CTA)
- Location: Bengaluru, Karnataka
- Experience: 3 months to 1 year
- Type: Immediate joiner preferred
Key Responsibilities
As a Clinical Trial Assistant (CTA), you will play a crucial role in supporting clinical trial operations. Your main duties will include:
Clinical Operations Support
- Documentation Management: Ensure accurate, timely filing of essential documents in the Trial Master File (TMF) and Study Management File (SMF) in compliance with Good Clinical Practice (GCP) standards.
- Site Communication: Serve as a liaison for investigational sites, facilitating effective communication and coordination.
- Regulatory Compliance: Assist in the preparation and submission of documents to regulatory authorities and ethics committees, post-approval by the Project Manager.
- Meeting Coordination: Schedule and organize project team meetings, site initiation visits, and monitoring visits, managing logistics and preparing necessary documents.
Data Entry and Database Management
- Data Collection and Tracking: Support data entry and quality control of study data, ensuring accuracy and completeness.
- Tracking Logs: Maintain up-to-date logs for site monitoring visits, document receipt, and adverse event tracking.
Study Supply Management
- Inventory Tracking: Assist in managing the inventory of investigational drugs and study supplies, coordinating timely dispatch to investigational sites.
- Site Supplies: Help prepare and ship study supplies, keeping accurate records of all shipments.
Administrative Tasks
- Invoice Processing: Track project-related financials and manage invoices and site payments.
- Training Support: Help organize training sessions for site staff, preparing and distributing training materials as needed.
Regular Job Activities
- Maintain and file documents in the TMF and SMF under the supervision of the Project Manager or CRA.
- Prepare and submit study status reports to the sponsor after obtaining necessary approvals.
- Assist in generating and maintaining study databases.
- Support shipment of study supplies to investigational sites and other relevant activities as directed by the Project Manager or CRAs.
Skills and Qualifications
- Experience: 3 months to 1 year in clinical trial operations or a related field.
- Skills: Proficiency in documentation management, regulatory compliance, data collection, and inventory tracking.
- Communication: Excellent verbal and written communication skills.
- Attention to Detail: Strong organizational skills and the ability to handle documentation accurately.
- Team Player: Ability to work collaboratively with cross-functional teams.
How to Apply
If you are ready to step into a role that supports critical clinical research and contributes to life-changing medical advancements, we encourage you to apply. Eligible candidates should send their resumes to career@samahitha.com.
