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.

Occupational Summary

As an Assistant Research Practice Manager [ARPM] in the Duke Cancer Institute [DCI], provide upper level leadership and day-to-day management for assigned teams. Oversee all aspects of clinical trial management, including site management, data entry and regulatory compliance. Ensure research is timely and compliant including federal, state, sponsor and institutional policies. Provide strategic direction and a vision for success.

Work Performed

Leadership

Embody 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. Create a culture that fosters open communication, motivates staff, and encourages creativity. Monitor team performance, encourage staff to be continuous learners and seek out, listen to and accept feedback.

Oversee the fair and consistent application of human resource policies, promptly address problems, and partner with the DCI Human Resource team to manage your teams effectively. Ensure staff are current with their required licenses and training. Cross-train and reassign staff as needed. Foster and encourage the professional development and training of staff: mentor and coach staff. Be available on a routine basis to provide leadership and facilitate effective teamwork.

Establish regular communication methods and meetings to manage the research portfolio, ensure compliance, and develop future research projects effectively including staff, Principal Investigators [PI], the DCI Finance Team, leadership, boards and others.

Maintain close collaborative working relationships with staff, colleagues and collaborators throughout the institution to ensure research comply with Duke Policies and Standard Operating Procedures [SOPs].

Ensure the conduct of studies is continuous, patients receive the best treatment, and research is in accordance with Duke Policies and Standard Operating Procedures [SOPs].

Financial Management

Apply knowledge of clinical trials management by developing and refining short and long-term financial goals for the research portfolio. Develop budget proposals and address budget-related issues in collaboration with the DCI Finance team, Duke Office of Clinical Research [DOCR] PIs, staff, colleagues and regulatory bodies. Ensure staff effort allocated appropriately. 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

Manage and solve the issues that arise during the conduct of clinical research. Support new and current research with creative strategies, monitor documentation and regulatory practices, and quality assurance reviews.

Serve 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. Collaborate closely with PIs to develop clinical research plans and protocols, interpret research results and prepare manuscripts for publication.

Regulatory

Ensure 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.

Ensure studies meet quality assurance standards and audits comply 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.

Supervisory

Manage the day-to-day assignments, work schedule, work location, time including time-off, complete yearly evaluations, actively engage in performance management, hire, terminate, and be a mentor and coach for direct reports.

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. Must have current or compact RN licensure in the state of North Carolina. BLS required.

Other work as assigned.

Skills

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.
1. Mastery of Microsoft Office, databases and information systems.

Basic Life Saving Certification from the American Heart Association or equivalent Duke approved course is a requirement.

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.

Preference

Clinical Trials experience with managerial background is preferred.

Minimum Qualifications

Education

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.

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.