"Clinical Research Manager II-TNC"

Position Summary/ Department Summary:

The Rosamund Stone Zander and Hansjoerg Wyss Translational Neuroscience Center (TNC) is seeking a dynamic and innovative Clinical Research Manager II (CRMII) to join our team. The TNC strives to improve the lives of all children with neurodevelopmental disorders by fostering timely and efficient translational research. The CRMI will collaborate with Principal Investigators and study stakeholders to manage the daily operations of research studies and will develop and oversee the implementation of best practice guidelines for conducting various research protocols. The CRMI will contribute to the development of budgets and monitor study finances, oversee maintenance of research equipment, and ensure compliance with hospital and governmental regulations. The CRMI will identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and act as a leader in overseeing their resolution. The CRMI will manage and train research staff and conduct the Performance Management process.

Key Responsibilities:

• Manage and oversee the work of research studies. Serves as research Study/Trial Manager for one or more large, clinical studies.
• Assist Principal Investigators in the design, development, and conduct of research studies.
• Collaborate with Principal Investigators and central staff on developing and writing grants and protocols, including independently drafting operational sections for submissions.
• Assist in developing curriculum and may conduct seminars/talks to train research staff in research regulations and best practices.
• Design and develop data management and data monitoring tools and procedures in compliance with GCP and program standards.
• Develop and manage the budget of clinical research staff and partner with the Principal Investigator in developing the study's budget.
• In collaboration with senior management, assists in establishing departmental/division policies and procedures for clinical research.
• Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.
• Conducts staff Performance Reviews.
• Performs other assignments as required.

Minimum Qualifications

Education:

• Bachelor's Degree and 7 years of relevant work experience (including 2 years of managerial experience) or master's degree and 5 years of relevant experience (including 2 years of managerial experience).

Experience:

• 7 years of relevant work experience (including 2 years of managerial experience) or master's degree and 5 years relevant experience (including 2 years of managerial experience).
• Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
• Demonstrate and maintain a high level of knowledge of regulations, research conduct, laws, guidelines, and standards relating to department/trials(s). Knowledge of federal, state, and community funding sources and mechanisms.
• Well-developed communication skills to provide critical information to internal and external stakeholders, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.
• Advanced writing skills.
• Knowledge of the principles and procedures of research.