Lambda Therapeutic Research, a renowned name in the field of clinical research, is hiring a Clinical Trial Assistant for its office in Ahmedabad. With over two decades of experience, Lambda is known for its robust clinical trial management, regulatory compliance, and data analysis capabilities, making it a trusted partner in healthcare innovations worldwide.
Job Responsibilities
As a Clinical Trial Assistant, you will play a pivotal role in the smooth execution of clinical trials. Below is a breakdown of your key responsibilities:
- Documentation Management:
- Assist the Project Manager (PM) in preparing, handling, distributing, filing, and archiving clinical documentation and reports.
- Ensure timely updates to Trial Master Files (TMF/E-TMF) and Site Master Files throughout the study duration.
- Site Coordination:
- Monitor site compliance and performance within project timelines.
- Act as the central contact point for the clinical team for designated projects, communications, and associated documentation.
- Data and Payment Tracking:
- Track and manage Case Report Forms (CRFs), clinical data flow, and queries.
- Oversee timely disbursal of investigator payments based on invoices received from sites.
- Administrative Support:
- Maintain trial-related documents and files within the facility.
- Update various study trackers assigned by the PM.
- Liaise with functional groups and provide updates to the Project Manager.
- Other Duties:
- Fulfill additional responsibilities assigned by supervisors, HODs, or management.
Qualifications Required
To qualify for this role, candidates must possess the following:
- Educational Background:
- B.Pharm, M.Pharm, MSc, BAMS, or BHMS.
- Experience:
- A minimum of 1 year of experience in clinical research.
Key Skills
The ideal candidate will have:
- Excellent organizational and multitasking abilities.
- Proficiency in clinical trial management and documentation.
- Strong communication and interpersonal skills to liaise effectively with functional teams.
- Knowledge of TMF/E-TMF maintenance and clinical data tracking.
- Attention to detail and commitment to regulatory compliance.
