JOB SUMMARY:
Provides operational and team member management of research personnel from Phase I-III, including but not limited to human resource management, financial accountability, productivity, and quality. Collaborates with PI’s, key management, and departmental teams to ensure efficiency and positive patient and staff outcomes. Embraces the concepts of Business Sustainability, Employee Development, Efficiency, Growth, Measurement and Quality as support of client’s vision for the Research Department. Lead and oversee the management of oncology clinical research operations across multiple sites. This role will ensure the efficient execution of oncology clinical trials, from feasibility to closeout, ensuring compliance with regulatory requirements, timelines, and budgets. The individual will also drive strategic initiatives to enhance site performance, improve patient recruitment, and optimize operational processes.
ESSENTIAL FUNCTIONS:
· Lead the clinical research operations team supporting a large portfolio of sponsored clinical research at multiple practice locations.
· Ensure regulatory compliance and monitor study coordinator activities including effective management of research patients per protocol and accurate and timely data collection.
· Develop and implement departmental processes and standard operating procedures (SOPs) to ensure compliance with federal, state, and local regulations and Good Clinical Practice (GCP) guidelines governing the conduct of clinical research in human subjects.
· Drive the development and implementation of new processes and workflows to improve site efficiency, coordination with client, and overall research quality.
· Provides or partners with other management to conduct employee interviewing, selection, retention, support, and encouragement of staff. Ensures staff has an in-depth knowledge of their jobs and appropriate tasks. Manage staff, balances workloads and assignments to obtain maximum productivity.
· Collaborate with counterparts at client on all aspects of research administrative functions including but not limited to: study activation/start up, centralized regulatory, budgeting/contracting (CDAs, CTAs, masters, vendor agreements), quality assurance and compliance, training/professional development, study operations, and research finance.
· Facilitate cross-functional collaboration internally and with client departments.
· Maintain and strengthen the brand integrity of the research program by ensuring the quality of data, speed to startup, sponsor satisfaction and profitability.
· Enhance and grow relationships with key strategic stakeholders.
· Implement and manage department specific software products as necessary including CTMS, eReglulatory, etc.
· Create KPI’s for all levels of the research team and communicate the results/outcomes for continuous learning/improving.
· Launch additional sites/locations as the practice grows throughout Tennessee and bordering states.
· Communicate success stories, metrics, issues, and potential solutions to practice leadership (administrative and physician).
· Develop and implement strategies to enhance patient recruitment and retention across the oncology portfolio.
· Lead the team to maintain a continuous growth and quality mindset.
· Travel to all research site offices as necessary.
· Other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
· Excellent communication skills
· Strong analytical, strategic planning, and problem-solving skills
· Must have thorough understanding of FDA regulations and GCP guidelines
· Ability to understand complex clinical trials protocols and document requirements.
· Ability to function as an effective team leader.
· Strong understanding of business management, financial, and leadership principles.
· Microsoft office product knowledge (Word, Excel, PowerPoint, etc.)
EDUCATION & EXPERIENCE:
· Bachelor’s degree in biology, life sciences or nursing, master’s degree in healthcare related field, MBA preferred.
· Five plus years direct clinical research experience, leadership/management experience