Job Description

Location: Thane, Mumbai

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Employment Type: Full time

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Open Positions: 2

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Key Responsibilities (but not limited to)-

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Use & ensure that Standard Operating Procedures (SOPs) concepts, practices in a time sensitive manner for all delegated projects and tasks.

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Responsible to ensure the overall success of the designated Clinical operations/ monitoring projects.

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Assist PM/APM in the development of study tools and training materials and compliance with standard processes, policies and procedures.

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Identify and initiate budget related discussions and recruit investigators in sync with Tech Observer/ sponsor's SOP's, GCP and local regulatory regulations.

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Assist the Project Manager to develop study management plans and generate tools to facilitate tracking of performance at project level.

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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.

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Ensure timely submission of protocol and study related documents for EC/IRB approval.

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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.

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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.

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Maintaining regular contact with study sites to ensure protocol/GCP compliance.

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Communicate progress of study and relevant information to PM/APM and other project team members.

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Assist PM/ APM in generation of accurate study status report for delegated studies in a timely manner.

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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.

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Follow up with sites for resolution of CRF queries in a timely manner.

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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.

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Assist in vendor management activities (e.g. IVRS, Drug Management, Courier Services, Lab, Printing, etc.) based on the delegation of activities in the study.

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Providing support in effective and compliant Adverse Event Reporting/ Serious Adverse Event reporting to all stake holders in accordance to the Sponsor/ Tech Observer SOP's, Protocol, GCP and local regulatory guidelines.

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Other responsibilities as delegated by the reporting Head/ management

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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