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
• Perform site evaluation visits and assess investigator-site capability
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Maintain audit-ready Investigator Site Files and ensure timely document upload to the Trial Master File
• Communicate directly 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 and coordinate return or destruction of unused materials
• Serve as primary site contact and coordinate correspondence and timely clinical-data transmission
• Perform study close-out visits, investigational-product reconciliation, site-file reconciliation, query resolution through database lock, and outstanding-action 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
• Follow safety practices while traveling and visiting clinical research sites

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 attention-to-detail skills
• Ability to work independently, manage multiple tasks, and meet multiple deadlines
• Proficient computer skills and working knowledge of email, document, spreadsheet, and presentation software
• Ability to submit invoices and expense reports in accordance with Finance Department requirements
• Ability to follow safety, environmental, infection control, and protective-equipment guidelines
• Ability to lift and/or carry up to 10 pounds

Benefits:

• Contractor is responsible for their own insurance
• Home office environment available
• Travel-related work opportunities