Job Overview The Director of Clinical Trials plays a vital role in overseeing and managing clinical trials from inception to completion. This position requires a strong understanding of clinical research processes, FDA regulations, and Good Clinical Practice (GCP) guidelines. The ideal candidate will possess leadership skills and be able to supervise teams effectively while ensuring compliance with all regulatory requirements. This role is essential for the successful execution of clinical trials and contributes significantly to the advancement of scientific research.Duties

• Coordinate and manage all aspects of clinical trial operations, including planning, execution, and reporting.
• Ensure compliance with FDA regulations and GCP standards throughout the trial process.
• Supervise and lead cross-functional teams involved in clinical research activities.
• Develop and maintain study protocols, informed consent documents, and other essential trial documentation.
• Collaborate with investigators, sponsors, and regulatory agencies to facilitate smooth trial operations.
• Monitor trial progress, data collection, and adherence to timelines.
• Conduct training sessions for staff on clinical trial procedures and regulatory requirements.
• Analyze data using SAS or other statistical software to support research findings.
• Assist in the development of research proposals and grant applications.

Requirements

• Bachelor’s degree in a relevant field; advanced degree preferred.
• Proven experience in clinical research or clinical development roles.
• Strong knowledge of FDA regulations, GCP guidelines, and scientific research methodologies.
• Excellent leadership skills with experience supervising teams in a clinical setting.
• Proficiency in SAS or similar statistical analysis software is highly desirable.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Exceptional communication skills for effective collaboration with diverse stakeholders.
• A commitment to maintaining high ethical standards in clinical research practices.

Prime Revival Research Institute, LLC was established in 2015 and has been growing ever since. We have multiple site locations and 2 of those are focused on Oncology Clinical Research Trials. Our staff has extensive experience with clinical research and are thoroughly trained on regulatory guidelines. As Revival Research is growing, we are looking to add more experienced people to our team, and we offer plenty of room for growth in our organization.We are seeking full-time Clinical Research Coordinators with 3-10 years of experience in Oncology Clinical Research Trials. Clinical Research Coordinators are responsible to coordinate and manage multiple studies and responsible for assisting the Investigators and other clinical staff with study related tasks as follows but not limited to:Responsibilities:

• Overseeing the clinical trials, you are assigned to.
• Data collection and timely entries.
• Communicate with the study monitor.
• Informing participants about study objectives.
• Administering questionnaires as needed per study.
• Monitor participants to ensure adherence to study rules.
• Follow GCP guidelines and other regulatory standards.
• Participate in subject recruitment efforts.