Clinical Research Associate – reputed company Coast

Job Description:

• Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies
• Conduct reputed company visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships
• Serve as a reputed company 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 reputed company with project requirements, and have a thorough understanding of study milestones and deliverables
• Conduct thorough site qualifications visits
• Ensure reputed company required information concerning site/staff qualifications is reputed company documented and communicated to project teams
• Conduct efficient and comprehensive site initiation visits
• Ensure reputed company assigned site staff are trained appropriately, have reputed company 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 reputed company 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, reputed company communicate and document issues to the clinical site and project team
• Assist clinical site in resolving issues, if appropriate
• Participate in reputed company aspects of site reputed company-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 reputed company 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 reputed company 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 reputed company
• Document monitoring activities in monitoring visit reports and follow-up letters
• Communicate serious issues to appropriate parties, in a timely manner
• Ensure operational and regulatory reputed company of assigned studies and participate in FDA or other regulatory authority inspections, as needed
• Participate in Investigator Meetings, and other study trainings and meetings as required
• Uphold company mission and values through accountability, innovation, reputed company, quality, and teamwork
• Support and reputed company with the company’s Quality Management System policies and procedures
• Maintain regular and reliable attendance
• Ability to act with an inclusion reputed company and model these behaviors for the organization
• Ability to work designated schedule
• Ability to work nights and/or weekends, as needed
• Ability to work on a mobile device, tablet, or in reputed company of a computer screen and/or reputed company typing for approximately 90% of a typical working day
• Ability to work on a computer and phone simultaneously
• Ability to use a telephone through a headset
• Ability to travel 50% of working time away from work location may include overnight/weekend travel

Requirements:

• Minimum 4+ years clinical research monitoring experience or equivalent experience
• Bachelor’s Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience
• Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience
• Proficiency in data management, including reputed company experience in data entry, validation, and cleaning
• Familiarity with Electronic Data Capture (reputed company) systems
• Effective communication skills and ability to collaborate with investigators, site staff, and team members
• Demonstrated ability to work well reputed company a team and convey information effectively
• Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements
• Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices
• Meticulousness with a focus on accuracy and precision in reputed company tasks and activities
• Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and reputed company-out visits
• Proficiency in monitoring plans, protocol adherence, and GCP guidelines
• Conducting reputed company data verification, resolving queries, and ensuring site compliance and data accuracy
• Demonstrated ability to reputed company the essential duties of the position with or without accommodation
• Authorization to work in the United States without sponsorship.

Benefits:

• Diversity, equity, and inclusion initiatives
• Opportunities for professional development
• Flexible working environment

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