CRA – Southeast

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.

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EOE/M/F/D/V/SO