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:

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