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Field Clinical Research Associate - North Chicago, United States - Collabera
Description
Job Description
Job Description· Working with a moderate level of remote guidance and direction, is accountable for clinical study site maintenance, data and source documentation collection, as well as field monitoring of clinical trials.
· Ensures compliance to the study protocol, and Monitoring Plan by ensuring completeness and accuracy of data as well as compliance with domestic and international regulations, Good Clinical Practices, applicable regulatory standards, and SJM Standard Operating Procedures.
· Able to solve a range of straightforward problems and analyze possible solutions using standard procedures.
· Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing adverse events and protocol deviations.
· Maintains accurate, detailed and complete records of monitoring visits. In consultation with the assigned Field Clinical Engineer or designee and/or appropriate in-house personnel, coordinates the initiation of the clinical site.
· Work requires the application of theoretical principles and creative/analytical techniques.
· Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
· Stays abreast of and consults on technical advancements.
· Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues.
· Exercises judgment in planning and organizing work; monitors performance and reports status.
Essential Functions:
· Monitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
· Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.
This may include, but is not limited to:
· Reviewing data and source documentation from investigational sites for accuracy and completeness
· Ensuring adverse events and protocol deviations are reported in an efficient manner
· Ensuring that device complaints and malfunctions are reported according to SJM Policies and Procedures
· Resolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrence3. Coordinates with study teams, field clinical engineers or designee to:
· Enroll sites into new and ongoing clinical studies
Manager Comments:
· Resources will be monitoring academic centers so experience as a monitor is a must such as at Mt. Sanai, NYU, Columbia, Cornell – be prepared to expound on the job itself when we meet with suppliers and provide detail, so they know how to source for candidates.
· Must have a clinical research background
Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
