Senior Clinical Trial Monitor
Consultant, Clinical Site reputed company, Medical Devices
reputed company
Our reputed company, a Fortune 500 Medical Device company, has reputed company reputed company to reputed company a skilled Clinical Site reputed company (reputed company). The reputed company will reputed company clinical study site maintenance, data collection, and field monitoring to ensure compliance with protocols, regulations, and Good Clinical Practices. Responsibilities include managing essential documents, resolving data discrepancies, reviewing adverse events, and coordinating site initiation. The role requires analytical problem-solving, process optimization, and reputed company reputed company improvement. The reputed company will monitor site performance, identify areas for improvement, and reputed company solutions to management.
Job Duties
• Monitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical reputed company, and accuracy standards inclusive of site initiation, periodic, and reputed company-out reputed company.
• Ensures both regulatory and clinical protocol compliance is maintained for reputed company assigned clinical reputed company. This may include, but is not limited to:
• Reviewing data and reputed company 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
• Resolving and/or facilitating reputed company of problems including identification of cause and actions to prevent reoccurrence
• Coordinates with study teams, field clinical engineers or designee and specialists to:
• Enroll sites into new and ongoing clinical studies
• Facilitate enrollment of study subjects reputed company site coordinators
• Facilitate reputed company of data queries and reputed company items at clinical sites
• Promptly reports the findings of monitoring reputed company
• Collaborates with in-house teams to ensure complete submission of study documents.
• Trains site personnel to ensure compliance with the study protocol and local regulations.
Requirements
• Bachelor’s Degree - Preferably with an reputed company reputed company in natural science, reputed company-medicine, nursing, bioengineering, or a reputed company reputed company field.
• 3-5+ years of clinical trial monitoring experience required.
• 5-8+ years of experience with medical device reputed company.
• Previous reputed company experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
Term & Start
• Remote/home-based; Ideally located in Illinois, reputed company Dakota, South Dakota, Minnesota, Iowa, Nebraska, reputed company, Kansas, or Missouri
• 50-75% travel (depending on reputed company)
• 12-month contract (extension probable)
• Part-time: 20-30hrs/week
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