Susan DuPre

Experience

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  Clinical Research Atlanta

  May 2003 - now

  Certified Clinical Research Coordinator

  Recruit, screen and enroll trial subjects.Obtain Informed Consent.Conduct study visits per protocol.Proper storage, dispensing and overall accountability for study drug and study supplies.Complete CRF's and Source Documents accurately and maintain proper storage.Prepare for CRO visits and site initiations.Collect and package lab specimens according to IATA.Phlebotomy and ECG Procedures.AE/SAE collection and reporting.

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  Clinical Research Atlanta a Headlands Company

  Jan 2021 - now

  Site Operations Director

  **Leadership and Management:** Oversee the day-to-day operations of the clinical research site, ensuring that all studies are conducted in compliance with regulatory standards and protocols. **Regulatory Compliance:** Ensure adherence to FDA, ICH-GCP, and other regulatory guidelines, maintaining accurate and up-to-date documentation. **Budget and Financial Oversight:** Develop and manage the site's budget, including resource allocation, financial planning, and cost control, to optimize operational efficiency. **Study Coordination:** Coordinate with sponsors, CROs, and other stakeholders to initiate, conduct, and close clinical trials, ensuring timelines and objectives are met. **Team Management:** Recruit, train, and supervise clinical research staff, fostering a collaborative and high-performing team environment. **Quality Assurance:** Implement and monitor quality control processes to ensure the integrity of clinical data and the safety of trial participants. **Participant Recruitment:** Develop and execute strategies for participant recruitment and retention, maintaining enrollment targets. **Communication:** Serve as the primary point of contact between the research site, sponsors, CROs, and regulatory bodies, ensuring clear and effective communication. **Risk Management:** Identify potential risks related to clinical trials and develop mitigation strategies to address them. **Reporting:** Prepare and present regular reports on site performance, study progress, and financials to senior management and stakeholders. Show less