Clinical Research Associate – Level I/II, FSP, Multi Therapeutics

Job Description:

• Perform and coordinate clinical monitoring and site management activities for one specific sponsor
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required documentation and ensure audit readiness
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification and CRF review
• Assess investigational product through inventory and records review
• Document observations in reports and letters and escalate deficiencies to clinical management
• Maintain contact with investigative sites between monitoring visits and follow issues through resolution
• Participate in investigator meetings
• Engage daily with sponsor staff and complementary workers
• Qualify and initiate clinical trial sites in collaboration with the client company
• Perform trial close-out and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems such as the Clinical Trial Management System
• Facilitate communication among investigative 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 and tools and contribute ideas
• Contribute to process-improvement initiatives

Requirements:

• Bachelor's degree in a life sciences related field, or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship
• Valid driver's license where applicable
• Equivalency may consist of a combination of appropriate education, training and/or directly related experience
• 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, including communication with medical personnel
• Customer focus, listening skills and attention to detail
• Organizational and time management skills
• Effective interpersonal skills
• Flexibility and adaptability
• Ability to work independently or in a team
• Microsoft Office proficiency and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to travel frequently, generally 60–80%, including possible overnight stays

Benefits: