Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged : To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Job Description : We are seeking a motivated and experienced Assistant Director of Research Clinical Operations to support our clinical research programs across multiple clinics within our oncology practice. The Assistant Director will play a key role in ensuring the highest standards of clinical operations, quality assurance, and regulatory compliance for our research programs.ESSENTIAL FUNCTIONS : Strategic Clinical Leadership :
- Provide strategic leadership and guidance to enhance clinical research capabilities, operations, and quality across multiple sites.
- Develop and implement best practices, standard operating procedures (SOPs), and quality assurance measures to optimize research processes and outcomes.Clinical Research Operations Support :
- Collaborate with research site leaders, principal investigators, and research staff to ensure effective implementation and execution of clinical research protocols.
- Provide oversight and support for clinical trial management activities, including protocol development, patient recruitment, data collection, and regulatory compliance.Quality Assurance and Compliance :
- Establish and maintain clinical and quality assurance programs to monitor and evaluate the integrity and compliance of research activities with regulatory requirements, GCP guidelines, and institutional policies.
- Conduct regular audits and assessments of research operations to identify areas for improvement and implement corrective actions as needed.Training and Education :
- Collaborate with internal and external stakeholders to develop and deliver training programs and educational initiatives to enhance research staff competency and proficiency in clinical research methodologies, regulatory standards, and best practices.
- Provide mentorship and guidance to research staff to support their professional development and promote a culture of continuous learning and improvement.Collaboration and Communication :
- Foster collaborative relationships with internal and external stakeholders, including research site leaders, clinical staff, sponsors, regulatory agencies, and research partners.
- Communicate research updates, quality metrics, and performance outcomes to key stakeholders through presentations, reports, and meetings.Risk Management and Problem-Solving :
- Identify and assess potential risks and challenges in research operations and develop risk mitigation strategies to ensure the integrity and success of clinical research initiatives.
- Proactively address issues and obstacles encountered during research activities, working collaboratively with stakeholders to implement effective solutions and ensure study continuity.KNOWLEDGE, SKILLS & ABILITIES :
- Strong knowledge of clinical trial regulations, GCP guidelines, and quality assurance principles governing human subject research.
- Demonstrated leadership and management skills, with the ability to lead cross-functional teams and drive results in a complex, multi-site environment.
- Excellent communication, interpersonal, and problem-solving skills, with the ability to collaborate effectively with diverse stakeholders.
- Proven track record of implementing quality improvement initiatives, training programs, and regulatory compliance strategies in clinical research settings. EDUCATION & EXPERIENCE :
- Bachelor of Science in Nursing (BSN) required
- Current Registered Nurse (RN) licensure in the state of practice.
- 5+ years of clinical nursing experience in Oncology
- 5+ years of clinical research experience
- 2+ years previous leadership or management experience in a healthcare or research setting, with demonstrated success in leading teams and projects. PHYSICIAL REQUIREMENTS :
- Must be willing and able to lift to 25 pounds.
- Must be willing and able to travel to satellite clinics when necessary. TRAVEL REQUIREMENTS
- 0-25%
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