Seeking 1 Research Compliance Specialist
Onsite in Atlanta, GA Description: The Internal Research Monitor provides support for the Research Compliance Program by monitoring clinical trials and following established processes to support compliance with applicable regulations. The Internal Research Monitor conducts a variety of monitoring activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, the hospital's polices and applicable Food and Drug Administration (FDA) and other regulatory requirements.
Responsibilities: Ensures that research is being conducted in compliance with the study protocols, institutional policy and GCP. Reviews protocols and supports development of the study calendar within the OnCore system. Reviews the accuracy, completeness and timeliness of study related records, case report forms and other documents. Reviews study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines. Reviews drug or device accountability, tracking records, and clinical research pharmacy processes. Verifies that appropriate storage, supply, usage, instruction, documentation and disposition processes are in place and followed. Clinical research, monitoring, compliance, regulatory, Data review, project management, oncology, cardiology, healthcare, IRB, gcp About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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