GVK Biosciences Hiring for the Post of Sr. Clinical Research Associate || Life Science Freshers Apply Now, B8

Job Title: Sr. Clinical Research Associate
Job Description:

• Participate in the development of Clinical operations SOPs.
• Supporting the Project Manager in day to day functional activities/communications of the study.
• Assistance in implementation of Project Plans related to the Clinical Monitoring responsibilities
• Function as a lead monitor for a protocol or project, overseeing CRA performance and timeliness for monitoring.
• Participation in identification of investigators, collection of investigator documentation, site selection visits and site management responsibilities.
• Serving as the primary contact for the sponsor/clinical sites
• On-site Monitoring Responsibilities:
• Ensure study staff conducting the study have received the proper materials, instructions and training to complete the protocol requirements, as written.
•  Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
•  Ensure the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
• Ensure that the Site Regulatory Documents/EC are complete and current throughout the duration of the trial.
• Ensure that the Investigational product/study drug and accountability is accurate and that study materials are stored securely and per protocol requirements
• Complete process of SAE reporting, follow up of SAE's and safety mailing to sites.
• Prepare accurate and timely monitoring reports.
• Assistance/Perform in effective Planning, Set-up, Management and Closeout of Clinical Trials in order to meet the applicable GCP standards.
• Tracking the progress of projects and co-coordinating with Project manager to initiate appropriate actions to achieve target objectives
• Liaise with Project manager, team members and Sponsors to track study progress and milestones; regulate quality standards; resolve logistic and practical issues and promote the team-working environment.
• Initiate processes for assessing feasibility of a clinical trial after identifying the minimum requirements for participation of a site / investigator in the proposed study.
• To perform filing systems in routine for key study documentation.
• Prepare and communicate study updates to project manager and other study staff.
• Coordinate storage, distribution, tracking and distribution of clinical trial drug supplies
• Participation in the development of new clinical monitors i.e., training and co-monitoring.
• To be responsible for quality control of trial related activities and documentation
• Perform other related duties as assigned.

1. Qualification: B.Sc./M.Sc. Life Science
2. Experience: 0-2 years
3. Desired Skills: Thorough knowledge in the relevant field

Location: Gurgaon
How to Apply:
Apply through your Linkedin Account Here

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