Senior Clinical Research Associate - CRO-Contract

Job Description:

• Independently manage and monitor site activities for assigned clinical studies
• Conduct site qualification, site initiation, interim monitoring, and close-out visits
• Ensure compliance with protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines
• Perform site evaluation visits and assess investigators’ site capabilities
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Ensure Investigator Site Files remain audit-ready and documents are uploaded to the Trial Master File
• Communicate with investigational sites regarding visit planning, query resolution, action items, and site management
• Document clinical trial material accountability, stability, and storage conditions; perform investigational product inventory
• Coordinate site correspondence and ensure timely transmission of clinical data
• Perform close-out visits, investigational product reconciliation and disposition, study file reconciliation, query resolution through database lock, and outstanding action-item resolution
• Complete internal and study-related training within required timelines
• Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
• Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable

Requirements:

• Bachelor's degree or equivalent experience in life science/healthcare
• At least 5 years of field experience working within clinical research as a CRA
• Mastery of the CRA II Job Responsibilities
• Valid Driver’s License
• Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency
• Ability and willingness to travel up to 100% of the time, both domestically by land and air
• Expert knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process
• Proficiency in using electronic CRF platforms and processes
• Excellent interpersonal, organizational, and multitasking skills
• Exceptional attention to detail and professional judgment
• Ability to uphold ICH GCP guidelines and determine appropriate action for complex problems
• Ability to manage multiple deadlines and work independently
• Proficient computer skills and working knowledge of email, document, spreadsheet, and presentation software
• Ability to submit invoices and expense reports timely according to Finance Department requirements
• Ability to meet physical demands including occasional lifting/carrying up to 10 pounds
• Must follow safety, environmental, infection control, and protective-equipment requirements when traveling or visiting clinical research sites

Benefits:

• Contractor is responsible for their own insurance
• Home office environment option
• Opportunity to support mentoring, training, and assessment of CRAs and junior staff