Job DescriptionLocation: Thane, Mumbai
nEmployment Type: Full time
nOpen Positions: 2
nKey Responsibilities (but not limited to)-
nUse & ensure that Standard Operating Procedures (SOPs) concepts, practices in a time sensitive manner for all delegated projects and tasks.
nResponsible to ensure the overall success of the designated Clinical operations/ monitoring projects.
nAssist PM/APM in the development of study tools and training materials and compliance with standard processes, policies and procedures.
nIdentify and initiate budget related discussions and recruit investigators in sync with Tech Observer/ sponsor's SOP's, GCP and local regulatory regulations.
nAssist the Project Manager to develop study management plans and generate tools to facilitate tracking of performance at project level.
nPerform 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.
nEnsure timely submission of protocol and study related documents for EC/IRB approval.
nMaintain 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.
nAssist 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.
nMaintaining regular contact with study sites to ensure protocol/GCP compliance.
nCommunicate progress of study and relevant information to PM/APM and other project team members.
nAssist PM/ APM in generation of accurate study status report for delegated studies in a timely manner.
nEnsure the storage

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