Our client is a leading generic pharmaceutical company. Their team is now looking for a CRA - Southeast . Salary/Hourly Rate: $120,000 and up to 12% performance bonus Position Overview: The CRA - Southeast will monitor and manage clinical trial activities at assigned sites to ensure compliance with GCP. The CRA - Southeast will be the primary point of contact for site staff and investigators and will work closely with sites to complete required visits. Responsibilities of the CRA - Southeast: Manage site queries, protocol deviations and issues. Ensure sites are updating data systems, reporting AEs, SAEs and DS including any follow up. Ensure all activities associated with site management and monitoring (SQV, SIV, IMV, COV) are completed in compliance with ICH-GCP, SOPs, Clinical Monitoring plan (CMP), Protocol, study plans, local laws and regulations. Conduct site staff training and retraining. Maintain accurate and up to date study files, including regulatory documents and monitoring records. Support site audits and inspections. Required Experience/Skills for the CRA - Southeast: At least 5 years of experience in onsite monitoring. Strong knowledge of clinical research regulations, such as ICH-GCP guidelines. Willingness to travel extensively (up to 80%), including overnight stays. Experience handling serious adverse events and ensuring proper follow-up. Ability to deliver presentations confidently. Capable of managing clinical study coordinator teleconferences as needed. Skilled in using clinical trial management systems (CTMS), EDC platforms, and Microsoft Office. Effective at managing time and budgets. Experience with patient recruitment, retention strategies, and maintaining strong site relationships. Preferred Experience/Skills for the CRA - Southeast: Experience managing aspects of CRO functions is a plus. Education Requirements: A bachelor's degree in a scientific or healthcare field is preferred. Benefits: Health Insurance. Retirement plans. PTO. Atrium Staffing
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