Job Description

Consultant, Clinical Research Associate (Monitor),  Medical Devices

Summary

Our client, a Fortune 500 Medical Device company, has engaged GForce Life Sciences to source a skilled Clinical Site Lead (CSL). The CSL will oversee 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 continuous quality improvement. The CSL will monitor site performance, identify areas for improvement, and provide 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 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 Policies and Procedures
• Resolving and/or facilitating resolution 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 via site coordinators
• Facilitate resolution of data queries and action items at clinical sites
• Promptly reports the findings of monitoring visits according to processes.
• 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 academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
• 10+ years of clinical trial monitoring experience required.
• Familiarity with cardiac, vascular, and/or neuromodulation technologies.
• Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
• Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution

Term & Start

• Remote/home-based; Ideally located Midwest Region
• 50-75% travel (depending on clinical trials)
• 12-month contract (extension probable)
• Part-time: 25-30hrs/week

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