Job Summary:

The Department of Urology at the University of Rochester Medical Center is currently seeking a dedicated Senior Clinical Manager II to join our clinical trials and research team. The successful candidate will work collaboratively with faculty and residents to bring research ideas to fruition and support projects during their lifecycle. They will own all aspects of the research activities including maintenance of study timelines and project tracking database as well and development of study related documents, utilizing tools for process and project data tracking.

Our ideal candidate possesses a strong knowledge of research processes, guidelines, and data analysis to provide robust support in publishing and tracking of research outcomes.

Responsibilities:

• Oversee the management of clinical trials from initiation to completion, ensuring compliance with Good Clinical Practice (GCP) and relevant regulatory requirements.
• Collaborate with cross-functional teams, including research, medical, and operations to develop and implement clinical trial protocols.
• Conduct site visits and monitor trial sites to ensure compliance with GCP and relevant regulatory requirements
• Coordinate and manage patient enrollment, data collection, and data analysis.
• Utilize statistical software to analyze data and prepare reports for submission to regulatory authorities
• Maintain accurate and up-to-date documentation of all clinical trial activities
• Review clinical trial documentation for completeness and accuracy
• Demonstrate a thorough understanding of medical terminology and clinical laboratory procedures
• Utilize phlebotomy skills to collect blood samples as necessary
• Manage the day-to-day activities of clinical trials, including patient monitoring and clinical trial management
• Develop and implement procedures for patient recruitment and retention
• Ensure compliance with HIPAA regulations and maintain confidentiality of patient information
• Provide mentorship and training to junior clinical staff
• Participate in the development and review of clinical trial protocols and informed consent forms
• Collaborate with regulatory authorities to ensure compliance with relevant regulations
• Identify and report any potential risks or issues related to clinical trials
• Develop and maintain effective relationships with key stakeholders, including investigators, patients, and regulatory authorities
• Keep up-to-date with the latest developments in clinical trials and relevant regulatory requirements

Required Skills:

• Proven experience in managing clinical trials, including patient enrollment and data analysis
• In-depth knowledge of medical terminology and clinical laboratory procedures
• Familiarity with phlebotomy procedures and patient monitoring techniques
• Experience with clinical trials management, including compliance with relevant regulatory requirements
• Strong analytical skills and experience with statistical software
• Ability to work effectively in a fast-paced environment with multiple priorities
• Excellent communication and interpersonal skills
• Ability to maintain confidentiality of patient information and ensure compliance with HIPAA regulations
• Strong documentation and record-keeping skills
• Experience with systems and technology used in clinical trials management

PAY RANGE $63,815-95,723

This range represents the minimum and maximum compensation for this position. Individual rates will be set within this range and will be determined by considering factors including but not limited to market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better.

The University of Rochester is committed to fostering, cultivating and preserving a culture of diversity and inclusion. The University believes that a diverse workforce and inclusive workplace culture enhances the performance of our organization and our ability to fulfill our important missions. The University is committed to fostering and supporting a workplace culture inclusive of people regardless of their race, ethnicity, national origin, gender, gender identity, sexual orientation, socio-economic status, marital status, age, physical abilities, political affiliation, religious beliefs or any other non-merit fact, so that all employees feel included, equally valued and supported.

Job Type: Full-time

Pay: $63,815.00 - $95,723.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Medical Specialty:

• Oncology
• Urology

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: Hybrid remote in Rochester, NY 14642