Senior Clinical Research Associate

Location: Thane, Mumbai

Employment Type: Full-Time

Open Positions: 2

Key Responsibilities (but not limited to)-

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

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

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

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

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

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.

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

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.

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.

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

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

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

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.

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

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.

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

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.

Other responsibilities as delegated by the reporting Head/ management

Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.