• Administration and site level responsibility for clinical studies according to DNS Standard Operating Procedures, ICH Guidelines and GCP.
• Work as part of the DNS Project Team to contribute towards the management and execution of DNS Clinical Programs.
• Monitor study progress and milestones.
• Conduct pre-study, initiation, routine monitoring and closeout visits of study sites
• Co-monitoring and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring and closeout visits.
• Perform all aspects of study site management both whilst on-site and remote site management. Verifies compliance and quality of collected data.
• Verifies the receipt, handling, accounting, storage conditions, and availability of clinical products and supplies.
• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations,
• Identification and pre-qualification of potential investigators for upcoming DNS Clinical Trials.
• Perform study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation.
• Contribute to and/or develop the Monitoring Plan and ensure appropriate quality and timely monitoring of clinical sites.
• Prepare or provide input into status reports and act as primary contact for management regarding project activity.
• Ensure Management of Trial Master File
• Keep the Clinical Operations Lead informed of the progress of projects for which designated responsibility.
• Development and maintenance of good working relationship with investigators and study staff.
• Assist in the organization and participate in investigators’ meetings.
• Serve as point of contact for site personnel.
• Perform other duties as assigned by management.
• Available for extensive travel (~50%) including overnight stays.
• Ability to drive and have a valid California driver’s license.
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Thorough knowledge of CRFs, ICH Guidelines, GCP and the clinical trial process.
• Good understanding of the Clinical Trial process and study site management process including:
o Pre-study, initiation, monitoring and close-out visits
o Site management
o Vendor management
o Site regulatory documents
o Investigator agreements and contracts
o Site budgets and payment administration
• Understanding of clinical development, data management, study reporting and regulatory affairs sufficient to perform project lead responsibilities.
• Minimum 2-years of relevant clinical research experience including demonstrated skills and competency in monitoring and clinical project management tasks.
• Ability to manage clinical sites with minimal supervision.
• Ability to work within a project team.
• Good planning and organizational skills.
• Excellent verbal and written communication skills.
• Ability to represent DNS in a professional manner.
• Good computer skills with good working knowledge of a range of computer packages.