This listing was posted on Manatal ATS.
Senior Clinical Research Associate - REMOTE
Location:
Pune, Maharashtra
Description:
About the role: The Clinical Operations group is responsible for site management, monitoring tasks and support of clinical trials. The group allocates resources to projects as appropriate to assist with the implementation of project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures. Key Accountabilities: Coordinate the identification, feasibility assessment and selection of investigators and sites to undertake the study Prepare, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection Prepare and submit of regulatory and Ethics Committee packages and updates as appropriate in the local setting Negotiate site budgets, co-ordinate for site contract execution site payments, and track site payments Prepare for, plan, organise and conduct site initiation visits Develop and maintain appropriate monitoring tools and project specific documents Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines Mentor, coach, and train junior staff members as directed by line management Monitor study at allocated sites utilising both on-site and off-site activities including: Verification of quality, accuracy, completion, and timeliness of data Complete and efficient resolution of data queries, audits and issues Adherence to the study protocol, monitoring plan and other relevant project specific requirements Adherence to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of patient safety, and adverse/serious adverse events Collect, review (for quality and compliance) approve essential documents from study sites and code documents for filing Reconcile contents of in-house files and site files for responsible sites Complete all monitoring activities and progress reports, accurately and within the predetermined timeframe Coordinate distribution, tracking, handling and destruction of Investigational Product and other study supplies per site Maintain study information using the clinical trial management system and any other tracking and reporting tools for the project Perform project site close-out visit and other site closure related activities Any other responsibilities assigned by line manager What are our expectations of candidates? Tertiary qualifications in a related science or health care discipline At least five years experience in clinical trial monitoring within an academic, CRO or pharmaceutical environment Understanding of medical terminology and physiology Ex Excellent interpersonal skills, presentation skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders Excellent organisational skills ability to organise, take initiative and follow up independently Technological proficiency including Microsoft Office packages, electronic data capture and project management systems Ability and willingness to travel (up to 50%) Driving licence Ability to see the big picture, yet still focus on detail and quality of work Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments Please use the below link for job application and quicker response. https://lifelancer.com/jobs/view/0b63fc0a53526d2e389d5d02348861f7
Company:
Lifelancer
Posted:
May 23 on Manatal ATS
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More About this Listing: Senior Clinical Research Associate - REMOTE
Senior Clinical Research Associate - REMOTE is a Research Research Associate Job at Lifelancer located in Pune MH. Find other listings like Senior Clinical Research Associate - REMOTE by searching Oodle for Research Research Associate Jobs.
Senior Clinical Research Associate - REMOTE is a Research Research Associate Job at Lifelancer located in Pune MH. Find other listings like Senior Clinical Research Associate - REMOTE by searching Oodle for Research Research Associate Jobs.