• Perform and coordinate all aspects of the clinical monitoring and site management process • Conduct on-site or remote visits to assess protocol and regulatory compliance • Manage procedures and guidelines from different sponsors and/or monitoring environments • Ensure the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs • Ensure audit readiness and develop collaborative relationships with investigational sites and client company personnel • Assist the project manager or clinical team manager on assigned projects • Mentor and train junior clinical team members

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate • Demonstrates diligence in protecting the confidentiality of each subject/patient • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues • Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required • Supports subject/patient recruitment, retention and awareness strategies

• Support and lead the management of multi-center clinical research studies • Perform site monitoring visits for source document verification and assess site compliance • Coordinate and provide support for all aspects of study including protocol and site management • Develop and manage study metrics, providing training and mentorship to junior team members • Analyze trends in identified issues and author visit reports and letters • Oversee and manage operational aspects of clinical trial sites in conjunction with project teams • Collect and review essential documents for investigational sites • Serve as primary liaison for site management issues • Lead and train others in reviewing study site data and data reports • Perform all duties in compliance with standard operating procedures, federal guidelines, and other applicable laws • Develop, maintain, and present clinical trial and project specific training materials • Participate in training junior CRAs on moderately complex concepts, processes, and tasks

• Support candidate identification efforts • Conduct Comprehensive Industry & Market Research • Collaborate on Candidate Profiling & Sourcing • Assist in preparing essential search documentation • Help schedule and coordinate meetings • Serve as a primary point of contact for internal stakeholders • Update the internal database • Support the creation of marketing collateral • Monitor and share relevant industry news