Program Manager Clinical Research

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• Work under the direction of the Director, Quality Assurance and will provide constant feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA).
• Serve as the Administrator for the MECC Data and Safety Monitoring Committee.
• Work with the Director, Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies.

• Bachelor's degree required, master's degree preferred
• 5 years of work experience required
• Minimum of 3 years of experience in clinical research
• CCRP/CCRC Certification preferred
• Prior experience with internal audits and/or FDA inspection preparations.
• Demonstrated knowledge proficiency of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards, requirements, and guidelines related to clinical research
• Strong working knowledge of ongoing monitoring techniques (including criteria development and trending)
• Strong working knowledge of quality management principles, tools, and risk management techniques
• Analytical and critical thinking skills to recognize trends
• Demonstrated ability to manage projects: ability to prioritize, identify barriers and meet deadlines
• Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously
• Demonstrated communication, leadership, and team building skills: evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others
• Demonstrated skill in working with minimal supervision
• Effective written and verbal communication