Clinical Research Associate- Southeast USA

*CANDIDATE SHOULD BE LOCATED IN THE SOUTHEAST US*

The CRA will be primarily responsible for managing and monitoring clinical trial activities at assigned study sites to ensure compliance with protocol, Good Clinical Practice (GCP) and applicable regulatory requirements. The CRA will serve as the primary point of contact for investigators and site staff. The CRA will collaborate closely with sites to complete required site visits (SQV, SIV, IMV,COV) and perform site management activities to ensure project timelines and deliverables are met. The CRA must build and maintain strong collaborative relationships with investigative sites, as well as leverage strong knowledge of protocol to ensure subject safety, protocol compliance and validity of study data. The CRA must be well organized, have high attention to detail skills, adapt quickly to changing priorities and propose reasonable solutions. 

• 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
• Verify the accuracy and completeness of study data by performing source data review/source data verification (SDV/SDR)
• Conduct Site staff training and retraining on the study protocol requirements, study procedures 
• Manage site level queries, protocol deviations and issues, escalating as needed
• Ensure sites are updating data systems in a timely and accurate manner
• Ensure sites are reporting AEs, SAEs, and DS including any follow up in a timely and accurate manner
• Prepare and submit visit reports, follow-up letters and other documentation in a timely manner  
• Maintain accurate and up to date study files, including regulatory documents and monitoring records. Support site audits and inspections.
• Support site feasibility assessments and patient recruitment strategies. Act as a liaison between sites and sponsor, ensuring effective communication and issue resolution
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Attend project meetings and provide update son site status and progress
• Identify risks and recommend mitigation strategies.

Qualifications:

• Bachelor’s Degree in scientific discipline or health care preferred
• Minimum 5 years of onsite monitoring experience
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., ICH – GCP guidelines.
• Experience managing aspects of CRO functions is a plus
• Ability to travel up to 80%, including overnight stays
• Experience managing serious adverse events in collaboration with safety surveillance. Ensuring events are being properly followed to completion
• Have effective organizational, communication and interpersonal skills
• Ability to lead and conduct presentations 
• Coordinate, organize, and manage clinical study coordinator teleconferences on a routine basis, when necessary
• Proficiency in clinical trial management systems (CTMS), EDC platforms, and Microsoft office suite
• Strong analytical and problem-solving abilities.
• Experience working in a fast paced, collaborative environment
• Effective time and financial management skills
• Prior experience in patient recruitment & retention strategies and site relationship management