Location: Thane, Mumbai /n /n Employment Type: Full-Time /n /n Open Positions: 2 /n /n Key Responsibilities (but not limited to)- /n Use & ensure that Standard Operating Procedures (SOPs) concepts, practices in a time sensitive manner for all delegated projects and tasks. /n /n Responsible to ensure the overall success of the designated Clinical operations/ monitoring projects. /n /n Assist PM/APM in the development of study tools and training materials and compliance with standard processes, policies and procedures. /n /n Identify and initiate budget related discussions and recruit investigators in sync with Tech Observer/ sponsor’s SOP’s, GCP and local regulatory regulations. /n /n Assist the Project Manager to develop study management plans and generate tools to facilitate tracking of performance at project level. /n /n Perform on-site/ remote monitoring visits, including site qualification, initiation, monitoring and closeout visits in sync with Tech Observer/ sponsor’s SOP’s, Monitoring plan, GCP and local regulatory regulations. Assist in investigator meetings including preparation, liaison, presentations, problem resolutions, and follow up with site staff as well as vendor and sponsor. /n /n Ensure timely submission of protocol and study related documents for EC/IRB approval. /n Maintain TMF and review ISF and other regulatory documentation on an ongoing basis in compliance with Tech Observer/ Sponsor SOP’s, GCP and local regulatory requirements. /n /n Assist Project Manager (PM)/ Assistant Project Manager (APM)



in drafting the recruitment strategies and provide inputs towards steps for mitigating recruitment challenges. Motivate investigators in order to achieve recruitment targets. /n /n Maintaining regular contact with study sites to ensure protocol/GCP compliance. /n /n Communicate progress of study and relevant information to PM/APM and other project team members. /n /n Assist PM/ APM in generation of accurate study status report for delegated studies in a timely manner. /n /n Ensure the storage of Investigational product (Medicine/ device) is compliant to protocol specified requirements and keep diligent account of all drugs in accordance with SOPs. /n Follow up with sites for resolution of CRF queries in a timely manner. /n /n Ensure that the study documents (at site/ with Tech Observer) are being archived in accordance with Tech Observer/ Sponsor’s SOP’s, GCP and local regulatory regulations. /n /n Assist in vendor management activities (e.g.

IVRS, Drug Management, Courier Services, Lab, Printing, etc.) based on the delegation of activities in the study. /n /n Providing support in effective and compliant Adverse Event Reporting/ Reliable Adverse Event reporting to all stake holders in accordance to the Sponsor/ Tech Observer SOP’s, Protocol, GCP and local regulatory guidelines. /n /n Other responsibilities as delegated by the reporting Head/ management /n /n Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.

📌 Senior Clinical Research Associate (Mumbai)
🏢 Tech Observer
📍 Mumbai