Clinical Research Associate, CRA II/SR CRA I/SR CRA II

Job Description:

• Perform and coordinate all aspects of clinical monitoring and site management
• Conduct remote and onsite visits to assess protocol and regulatory compliance
• Manage required documentation, sponsor procedures and monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs
• Protect subjects' rights and well-being and ensure data reliability
• Maintain audit readiness and collaborative relationships with investigational sites
• Apply risk-based monitoring, root cause analysis and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with sites between monitoring visits
• Participate in investigator meetings and identify and initiate qualified investigator sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct onsite file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update clinical trial management systems
• Facilitate communication among sites, the client company and the PPD project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Assist with project publications, tools and process-improvement initiatives

Requirements:

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
• At least 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship
• Equivalency combining appropriate education, training and/or directly related experience may be considered
• Valid driver's license where applicable
• Proven clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Working knowledge of ICH GCPs, applicable regulations and procedural documents
• Critical thinking, root cause analysis and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills
• Good organizational and time management skills
• Effective interpersonal skills and attention to detail
• Flexibility and adaptability
• Ability to work independently and in a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Candidates must be located in AZ, CA, CO, ID, MT, NM, NV, OR, UT, WA or WY
• Up to 75% regional travel and frequent onsite visits across the US

Benefits:

• Variable annual bonus based on company, team, and/or individual performance results
• National medical and dental plans
• National vision plan, including health incentive programs
• Employee assistance and family support programs
• Commuter benefits
• Tuition reimbursement
• At least 120 hours paid time off (PTO)
• 10 paid holidays annually
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave
• Accident and life insurance
• Short- and long-term disability
• 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) with company stock discount

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