Senior Clinical Research Associate – CRO Contract
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Job Description
Contract Senior Clinical Research Associate monitoring clinical-trial sites for Lotus Clinical Research. Ensuring GCP, FDA, ICH, protocol, and study-document compliance through site visits.
Responsibilities:
- 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
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