Clinical Site Lead

SummaryOur 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 DutiesMonitors 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.Reviewing data and source documentation from investigational sites for accuracy and completenessEnsuring adverse events and protocol deviations are reported in an efficient mannerEnsuring that device complaints and malfunctions are reported according to the client’s Policies and ProceduresResolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrenceCoordinates with study teams, field clinical engineers or designee and specialists.Enroll sites into new and ongoing clinical studiesFacilitate enrollment of study subjects via site coordinatorsFacilitate resolution of data queries and action items at clinical sitesPromptly reports the findings of monitoring visits according to the client’s 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.RequirementsBachelor’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.Preferred Qualifications A general familiarity with cardiac, vascular, and/or neuromodulation technologies.Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institutionTerm & StartRemote with travel to sites in SoCal50-75% travel (depending on clinical trials)12-month contract (extension probable)Benefits available (Medical, Dental, Vision, 401k)