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 compliance, site documentation, investigational product accountability, and study close-out.
Responsibilities:
- 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
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