What are the responsibilities and job description for the Clinical Research Associate position at Tech Observer?
Contract for 4 months which can be extended further.
PFB Job Responsibilities :
Use 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.
Identify and initiate budget related discussions and recruit investigators in sync with Tech Observer/ sponsor’s SOP’s, GCP and local regulatory regulations.
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/SMF 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 Project Manager/Sr. CRA 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 outstanding 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
