CRA - Monitor Southeast
System One Holdings, LLC
CRA - Monitor Southeast
Location: Southeast USA - Must be based in Atlanta, GA or Orlando, FL or Tampa, FL or Charlotte, NC, or Nashville, TN Type: Contract Compensation: $65-71/hr W2 Work Model: Remote home office Hours: Part Time - 20 hours per week
Responsibilities
- Ensure sites meet study qualifications and monitor assigned study sites according to monitoring plans.
- Conduct continuous monitoring activities (onsite and remote).
- Implement site management activities to ensure compliance with protocol, GCP, and regulations to secure data integrity and patient safety.
- Serve as frontline liaison for Sponsor and sites to ensure successful collaboration.
- Respond to site questions and prepare reports.
- Participate in calls and meetings as part of the study team matrix.
- Travel approximately 60% of the time; a valid driver's license required.
Requirements
- Strong healthcare background with a college degree or graduation from an accredited school of nursing.
- At least five years of oncology monitoring experience, with specific experience in hematology studies (multiple myeloma, small cell lung cancer).
- Demonstrate professionalism, planning skills, and ability to work autonomously.
- Good communication skills, problem-solving abilities, and identification of key issues and trends.
- Knowledge of ICH, GCP, safety, and regulatory requirements; certification from SOCRA or ACRP preferred.
- Computer competency and familiarity with data management systems (e.g., Medidata RAVE).
- Experience in pharmaceutical, data management, or technical writing fields is a plus.
System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
System One Holdings, LLC$16.3 - $26.08 per hour
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