Ich/gcp Guidelines Jobs

This Lead Clinical Research Coordinator role at ProPharma involves managing and coordinating daily activities for Phase II-III industry-sponsored clinical trials from initiation to close-out. The position requires ensuring protocol compliance, data integrity, and participant safety while handling vendor management, subject recruitment, adverse event reporting, and regulatory documentation. Key responsibilities include performing clinical procedures like phlebotomy, leading monitoring visits, and collaborating with investigators and sponsors to optimize study operations. The role is appealing for its opportunity to work with a diverse team in a culture that values innovation, diversity, and authentic collaboration. While the position requires residency in New York City, it offers a hybrid work arrangement that balances remote flexibility with in-person office collaboration.

The Clinical Trial Monitor II role within the Clinical Trials Office at Dana-Farber Cancer Institute ensures research compliance with federal regulations and institutional policies. Key responsibilities include conducting remote data reviews and onsite monitoring visits to verify data accuracy, developing monitoring plans, and mentoring new team members. The position requires managing multiple projects simultaneously while promoting a culture of regulatory awareness. This opportunity appeals to professionals seeking to contribute to groundbreaking cancer research within an inclusive, mission-driven academic environment. The role is based in Boston with occasional travel required for onsite visits.

This on-site Clinical Research Coordinator role at Nebraska Methodist Health System supports the Methodist Physicians Clinic by managing the full lifecycle of clinical trials for investigational medications and devices. Key responsibilities include coordinating study start-up and regulatory compliance, recruiting and consenting participants, collecting and reporting accurate data, and performing specialized tasks such as interrogating implantable cardiac devices. The position offers the opportunity to work within a compassionate culture known as The Meaning of Care, where employees contribute directly to community health outcomes. The role provides a stable Monday through Friday schedule and fosters professional growth through collaboration with physicians and research teams.

The Senior Study Startup Specialist role leads complex global clinical trial start-up activities for SystImmune, a well-funded biopharmaceutical company focused on innovative cancer treatments. The position serves as a subject matter expert in site activation, regulatory submissions, and process optimization while mentoring junior team members. Key responsibilities include developing site activation strategies, managing contract and budget negotiations, overseeing CRO deliverables, and ensuring compliance with global regulations like ICH-GCP. This opportunity appeals to professionals seeking to drive continuous improvement in a fast-paced environment with a mission to advance oncology therapies. The role offers a hybrid work arrangement requiring three days onsite at the Princeton, NJ location.

This full-time on-site role supports clinical trials as a Research Pharmacy Technician within a collaborative healthcare environment. The position focuses on managing investigational products by receiving, storing, and dispensing medications while maintaining strict compliance with FDA regulations and study protocols. Key responsibilities include performing precise aseptic preparations, maintaining real-time accountability logs, and managing data entry in clinical trial systems. The role appeals to detail-oriented professionals who value precision and teamwork, offering opportunities for professional development and a supportive culture dedicated to improving healthcare quality. The schedule is Monday through Friday with a focus on regulatory adherence and operational efficiency.

The Clinical Scientist II role supports ATEC's spine surgery division by leading clinical research and evidence generation efforts. Key responsibilities include designing research protocols, managing large datasets, and collaborating with cross-functional teams and key opinion leaders to align studies with business objectives. The position requires translating complex data into clear technical documentation and scientific communications for internal and external audiences. This opportunity appeals to candidates seeking to advance medical device innovation within a fast-paced environment that values rigorous statistical analysis and strong technical writing. The role involves working closely with the Scientific Affairs team to drive product credibility and clinical impact.