Job Summary

Manages the day-to-day clinical research operations of the Research Institute in partnership with the Director. Manages the Clinical Research Operations and Clinical Trials Unit team who serve Nicklaus Children's Health System community of investigators. Oversees the evaluation of feasibility of new clinical research studies.

Job Specific Duties

• Collaborates with cross-functional teams to develop and implement comprehensive clinical trial strategies, ensuring alignment with organizational objectives.
• Trial Management - oversee all aspects of clinical trial management from study start-up through study closure.
• Leads and mentor a team of clinical research professionals, providing guidance, support, training, and career development.
• Responsible for employee hiring, promotions, disciplinary actions, and termination in partnership with the Director.
• Participates in the development, review, and implementation of SOPs.
• Works with Director to develop and execute processes to ensure compliance to all state and federal regulations.
• Identify and implement opportunities for process improvement.
• Demonstrate and leads best practices, standardized procedures, and technological improvements to streamline workflows and enhance overall trial execution.

Minimum Job Requirements

• Bachelor's Degree in Biomedical or Business Management
• Clinical research certification (e.g. CCRC, CCRP or CCRA)
• 7-10 years of clinical research experience in either an academic hospital engaged in research, university, Clinical Research Organization, or Pharmaceutical/Medical Device company setting

Knowledge, Skills, and Abilities

• Strong working Knowledge of federal regulations governing research.
• Strong working Knowledge of the types of clinical research.
• Proven problem solving skills.
• Demonstrated experience working cooperatively and constructively with clients and co-workers.
• Proficient in using clinical trial management systems (CTMS) and other relevant platforms and applications.
• Effectively monitor and develop the abilities of subordinates.
• Ability to manage personnel issues and to provide critical feedback when applicable
• Possesses strong attention to detail and follow-up skills.
• Ability to communicate effectively both verbally and in writing.
• Ability to use logical thinking to interpret research study protocols and solve a broad range of problems.
• Display strong analytical skills and provide productivity assessments.
• Ability to interpret, adapt, and react calmly under stressful conditions.
• Able to maintain confidentiality of sensitive information.