Work as Clinical Research Coordinator/Clinical Research Associate at Datt Mediproducts

Datt Mediproducts Pvt. Ltd is one of the top surgical and advanced woundcare companies in India and has emerged as a global organization. The Company is global expertise in medical textile and advanced woundcare products.

Post : Clinical Research Coordinator/Clinical Research Associate

Primary Responsibilities:
• To write, edit, review manage high quality medical and scientific documentation for Clinical research for submission to regulatory authorities and/ethics committee.
• Follow DMPL specifications for documentation, templates etc.. and track the clinical trial milestones for assigned projects.
• Maintain records for all assigned projects including archiving.
• To maintain audit,Monitoring, SOP and training compliance record.
• Have to perform additional tasks as assigned
• He/She should be in a position to address the requirements of FDA and EU, MHRA, CBER, EMEA norms for clinical trials,
• Interact with regulatory bodies/ ethics committee whenever required,
• Ability to learn new rules and guidelines, techniques, trouble shoot experiments, design experiments and execute them within tight timelines is a must,
• Highly motivated to work in a team environment and enthusiastic to train in cross-functional areas
Specific Skills required:
• Proper knowledge on medical devices and its classification as per later latest guidelines and rules
• Basic understanding of Indian GCP, ICH-E-6.
• Should be well versed with preparation of protocols and CSRs on medical devices
• Excellent record keeping and computer skills especially well-versed with Microsoft office