Senior Clinical Research Project Manager
The Clinical Research Manager assumes responsibility for clinical trials project management operations of the URCC NCORP Research Base under supervision from the Executive Director of Research and URCC MPIs. This position requires strong management and interpersonal skills, with a background in the management of clinical research activities and project management. This position will assume responsibility for compliant administrative and regulatory conduct of the studies as a liaison between Study Chairs, URCC Leadership, NIH, URCC Operations Office cross functional teams, our Division personnel, and our external collaborators. The position will oversee a team of assigned Clinical Research Project Managers and be responsible for the timely development, launch, conduct and close out of large, national, multi-site clinical trials. This includes creating and maintaining best practices and SOPs, and ensuring that assigned project management staff are appropriately resourced and adhering to policies and procedures.
JOB DUTIES AND RESPONSIBILITIES:
Oversight of assigned study personnel including orientation, training, documentation of core competencies, certification mandates, safety/responsible conduct of research education and performance evaluations, including the following tasks:
Manages the day-to-day operations, issue resolution, and supervision of assigned staff.
Completes annual performance evaluation process; ensures fair and accurate evaluation following standards of performance. Provides counseling and constructive feedback for employee development.
Addresses disciplinary issues.
Carries out all actions as to hiring, transfers, promotions and terminations of clinical research staff. Performs QA and supervision of team clinical trial project timelines, adherence to procedures, and all other activities.
Participates in staff recruitment and retention initiatives. Participates in Research Base wide team building and training activities.
Directs the planning, implementation and coordination of multi-center clinical trials run through the URCC Research Base NCORP national network. Is responsible for efficient conduct of the assigned projects from study start up, protocol amendments, to closure and data analysis.
Serves as the liaison to the Principal Investigator, URCC leadership, community sites and all key stakeholders. Ensures all research team members understand scope of each project and individual responsibilities. Allocates and assigns personnel and technical resources to meet specific study and general research needs.
Provides professional direction and oversight for large, multi-center national projects across more than 600 community sites throughout URCC’s NCORP network. This includes providing high level direction for institutions outside of URMC on an ongoing, regular basis.
Plans internal meetings and provides direction to the clinical trials project management team. Oversees the planning and implementation of the Investigator’s/Coordinators’ meeting. Plans the clinical research project timeline and regularly monitors adherence, metrics and progress throughout the study lifecycle. Regularly presents a status overview to URCC Leadership.
Engages with Finance for budget development and budget management when applicable.
Works with assigned Project Managers and URCC’s regulatory team to ensure and track regulatory compliance for multicenter studies.
Tracks and documents research milestones and activities conducted through URCC’s national network for the purpose of meeting NIH goals.
Communicates frequently with external institutions to assure compliance with multicenter research activities and provides direction for those institutions in regard to research compliance, training, recruitment, and reporting.
Assists in the training, onboarding, and participation of national community site personnel at external institutions.
Assists in the development and creation of both project-specific documents used at multiple institutions such as protocols, consent forms, source materials, recruitment materials and database forms, and cross-
project documents such as policies and procedures.
Complies with Good Clinical Practice and the Code of Federal Regulations
Creates and maintains standard operating procedures
Assists with the coordination of all phases as it relates to the URCC NCORP Research Base’s study start-up, data reporting, and close-out of research projects
Requires a thorough understanding of proposed and active protocols
Provide professional direction for projects.
Prepare for internal and external audits
Maintain working knowledge of the specialty as well as the current regulations, industry standards and good clinical practices for conducting individual protocols.
Attend meetings and pertinent seminars in academic settings.
Other projects and duties as assigned.
Bachelor’s degree required
5 years of experience in clinical research, project management, or relevant work experience or equivalent combination of education and experience required.
1 year of leadership experience preferred
Demonstrated leadership skills and competency. Ability to effectively manage complex research protocols/procedures.
Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards. Proficiency in managing multiple and competing priorities/demands.
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, and applicable safety standards, throughout study implementation.
Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork.
Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, and empathy for patients).
Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet.
Possesses a high degree of self-motivation; recognized ability to function independently.
Professional Research Coordinator certification (SoCRA or ACRP) preferred
Project Management preferred
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. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range: $ 75,300 - $113,000 Annually
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation 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.
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