Clinical Research Associate; Los Angeles

Responsibilities

• •This position is responsible for executing, managing and conducting projects associated with the company clinical study plans
• •The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team
• •Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies
• •Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships
• •Serve as a point of contact for investigators and site staff
• •Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates
• •Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
• •Conduct thorough site qualifications visits
• •Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams
• •Conduct efficient and comprehensive site initiation visits
• •Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements
• •Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs
• •Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies
• •Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements)
• •Ensure all clinical site staff actively participating in the study are appropriately trained
• •Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team
• •Conduct device/product accountability responsibilities at clinical sites;
• •Identify, clearly communicate and document issues to the clinical site and project team
• •Assist clinical site in resolving issues, if appropriate
• •Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management
• •Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members
• •Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study
• •Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members
• •Communicate project specific information to/from trial sites through teleconferences, newsletters, etc
• •Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis
• •Document monitoring…
• •23 more items(s)