ASSIST RESEARCH PRACTICE MANAGER
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Oncology Clinical Research Unit (OncCRU) Administration
Reporting Relationship: Reports to the Research Practice Manager (RPM) for the Oncology Clinical Research Unit (CRU)
An Assistant Research Practice Manager (ARPM) in the Duke Cancer Institute (DCI) provides upper level leadership and day-to-day management for a talented, diverse and dedicated staff of clinical research professionals. The ARPM ensures research is timely and compliant with all federal, state, sponsor and institutional policies. The ARPM is the cornerstone of their clinical research team providing strategic direction and a vision for success.
The ARPM is charged with managing and solving the issues that arise during the conduct of clinical research. This charge includes supporting new and current research with creative strategies; monitoring documentation and regulatory practices; orientating and training staff; human resource management; financial oversight of research; quality assurance reviews; effectively communicating with all parties involved in the conduct of research; and maintaining a close, collaborative working relationship with staff, colleagues and collaborators throughout the institution to ensure research is conducted in accordance with Duke Policies and Standard Operating Procedures (SOPs).
Leadership, 40% of Effort
The ARPM embodies the DCI’s core value “Cancer Care as It Should Be” to deliver the highest quality care in our patient-centric clinical research, as a leader of research staff and for all of the DCI. The ARPM creates an inspiring team environment with a culture that fosters open communication, motivates team members, encourages creativity, provides coaching, sets clear measurable goals, monitors team performance, encourages staff to be continuous learners and seeks out, listens to and accepts feedback.
The ARPM oversees the fair and consistent application of human resource policies, promptly addresses problems, and partners with the DCI Human Resource team in the management of their team. Establishes processes to ensure and document staff are current with their required licenses and training. Ensures the conduct of studies is continuous and patients are provided the best treatment by cross-training and reassigning staff as needed. Fosters and encourages the professional development and training of their staff. Is available to staff on a routine basis to provide leadership, mentor and facilitate effective team work.
The ARPM establishes regular communication methods and meetings with staff, Principal Investigators (PI), the DCI Finance Team, senior leadership, boards and others to effectively manage the research portfolio, ensure compliance, and develop future research projects.
Financial Management 25% of Effort
Apply knowledge of clinical trials management by formulating and refining short and long term financial goals for the research portfolio. Develop budget proposals and address budget-related issues by partnering with the DCI Finance team, Duke Office of Clinical Research (DOCR) PIs, staff, colleagues and regulatory bodies. Ensure staff effort is regularly and appropriately allocated. Regularly review finances to ensure financial objectives are met and compliant with policy. Recommend corrections as needed. Be knowledgeable of funding sources including industry, federal and foundation grants.
Study Conduct 25% of Effort
Serves as an expert resource on the conduct of research. Identify subject recruitment barriers and develop solutions. Implement solutions to clinical, logistical, financial and regulatory issues. Collaborates closely with PIs to develop clinical research plans and protocols, interpret research results and prepare manuscripts for publication.
Regulatory 10% of Effort
Ensures studies are compliant with the regulatory and documentation requirements of the School of Medicine (SoM), the Institutional Review Board (IRB), DOCR, the institution, sponsors, the FDA, and other groups.
Ensures studies meet quality assurance standards and audits are conducted regularly in compliance with policy. Review and respond to audit reports, develop and implement corrective action. Ensure coordination and preparation of monitoring visits, timely query follow up and completion.
Licensed RN (when applicable)
Operate within the scope of the professional capacity of a licensed RN as it relates to research. Provide direction and training to nursing staff as needed.
Other work as assigned.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Oncology experience with managerial background is preferred
Qualifications Required At This Level
Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.
Work requires a minimum of six years of related experience, with at least four years in a research setting. A Master's degree may substitute for two years of related experience.
- Excellent written, oral and conversational communication skills to work effectively with diverse groups. Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills. Excellent time management skills needed to prioritize among many projects both in development and in operation. Attention to detail needed to operate accurately and effectively.
- Mastery of Microsoft Office, databases and information systems
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.