Clinical Research Associate

About the role

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

• Monitor 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.
• Ensure both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.
• Review data and source documentation from investigational sites for accuracy and completeness.
• Ensure adverse events and protocol deviations are reported in an efficient manner.
• Ensure that device complaints and malfunctions are reported.
• Resolve and/or facilitate resolution of problems including identification of cause and actions to prevent reoccurrence.
• Coordinate 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 report the findings of monitoring visits.
• Collaborate with in-house teams to ensure complete submission of study documents.
• Train 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.
• 3–5+ years of clinical trial monitoring experience required.
• 5–8+ years of experience with medical device clinical trials.
• Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.

Term & Start: Remote/home-based; ideally located in Boston, MA. 50–75% travel (depending on clinical trials). 12-month contract (extension probable). Part-time: 20 hrs/week.