Mgr, Clinical Research Operations

Day (United States of America)

400 CELEBRATION PL

CELEBRATION

Florida

34747

Develops approaches to monitor and evaluate the quality of clinical operations at AHRI. Works with regulatory specialists to implement steps necessary to meet compliance with outside regulatory agencies. Manages the delivery of safe care with regard for the dignity and respect of all patients/participants. Manages all duties necessary for effective and compliant clinical research study coordination across multiple therapeutic areas, including planning, organizing, and managing all activities related to clinical research operations and execution of timelines. Collaborates with managers in Research Services, Study Intake, Portfolio Management, and clinical study coordinators to develop study budgets for all research projects within supported therapeutic areas. Works with Sr. Clinical Operations Manager and AHRI Core Managers to develop and implement processes that ensure workflow and scheduling are optimized for clinical operations. Works collaboratively with peer Clinical Operations Managers to resource and staff all projects within the AHRI portfolio, including those outside of primary therapeutic areas. Provides leadership for research participant recruitment, data entry, and data management, ensuring optimal recruitment and standardization across all research teams within AHRI. Performs managerial duties related to the selection, management, development, and appraisal of research staff. Collaborates with other research departments to ensure federal, state, local, and institutional regulatory compliance. Assists in establishing and maintaining Standard Operating Procedures (SOPs) for clinical operations, research training, and certification for staff. Ability to understand situational needs, stakeholder input and drive staffing and resourcing decisions that drive optimal research participant enrollment and trial execution to completion Other duties as assigned.Knowledge, Skills, and Abilities:
• Ability to lead, accept responsibility, exercise authority, and function independently using effective written and verbal communication in English [Required]
• Ability to harmonize interests of investigators, stakeholders, and customers within the organization to drive research operations [Required]
• Knowledge of regulations governing the conduct of clinical research [Required]
• Specialized knowledge of the unique needs of volunteers participating in clinical trials [Required]
• Ability to understand situational needs, stakeholder input, and drive staffing and resourcing decisions that drive optimal research participant enrollment and trial execution to completion [Required]
• Sensitivity to cost-containment measures and ability to create an atmosphere which encourages this practice [Required]
• Proficiency in Microsoft Outlook, Word, Excel, and Access and ability to learn business-relevant software and tools [Required]
• Extensive experience in coordinating industry-sponsored and investigator-initiated clinical trials [Preferred]
• Proficiencies in managerial knowledge and skills [Preferred]

Education:
• Bachelor's [Required]
• Master's [Preferred]

Field of Study:
• Healthcare Administration or Business

Work Experience:
• 10+ experience as lead research coordinator or research manager with increasing people management responsibilities [Required]
• 5+ experience as a research nurse/registered nurse or non-nurse coordinator in healthcare setting or research site [Required]
• 5+ experience in a healthcare or research setting with demonstrated experience managing teams [Required]
• 7+ experience as a research nurse/registered nurse or non-nurse coordinator in healthcare setting or research site [Preferred]
• Demonstrated experience staffing, resourcing and scheduling clinical study coordinator and data teams to meet the needs of a diverse portfolio of research studies [Preferred]

Additional Information:
• N/A

Licenses and Certifications:
• Registered Nurse (RN) [Preferred] AND
• Basic Life Support - CPR Cert (BLS) [Preferred] AND
• Certified Clinical Research Coordinator (CCRC) [Preferred] AND
• Association of Clinical Research Professionals (ACRP) [Preferred] OR
• Society of Clinical Research Associates (SOCRA) [Preferred]

Physical Requirements: (Please click the link below to view work requirements)
Physical Requirements - https://tinyurl.com/23km2677

$79,402.93 - $147,697.47