Clinical Research Associate

Consultant, Clinical Site Lead, Medical DevicesWhile professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.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. This may include, but is not limited to: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 reportedResolving 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 to: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 visitsCollaborates 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.3-5+ years of clinical trial monitoring experience required.5-8+ years of experience with medical device clinical trials. xhyhwjd Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.Term & StartRemote/home-based; Ideally located in Philadelphia, PA, or New York, NY50-75% travel (depending on clinical trials)12-month contract (extension probable)Part-time: 20hrs/week