Job Description Location: Thane, Mumbai
n Employment Type: Full-Time
n Open Positions: 2
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 Responsible to ensure the overall success of the designated Clinical operations/ monitoring projects.
n Assist PM/APM in the development of study tools and training materials and compliance with standard processes, policies and procedures.
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 Assist the Project Manager to develop study management plans and generate tools to facilitate tracking of performance at project level.
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 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 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 Maintaining regular contact with study sites to ensure protocol/GCP compliance.
n Communicate progress of study and relevant information to PM/APM and other project team members.
n Assist PM/ APM in generation of accurate study status report for delegated studies in a timely manner.
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 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 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 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 Other responsibilities as delegated by the reporting Head/ management
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 (Raigarh)
🏢 Tech Observer
📍 Raigarh