Clinical Research Associate I/II
Job Category:Clinical Development
Who We Are
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!
• 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.
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.
Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.