RESEARCH PRACTICE MANAGER ONCOLOGY CLINICAL RESEARCH HYBRID

RESEARCH PRACTICE MANAGER ONCOLOGY CLINICAL RESEARCH HYBRID

Work Arrangement : Hybrid (On-Site and Remote mix) Requisition Number : 230727 Regular or Temporary : Regular Location :

Durham, NC, US, 27710

Personnel Area : MEDICAL CENTER Date : May 23, 2024 School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools.

Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health.

a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Research Practice Manager RPM , Oncology Clinical Research Unit OncCRU

Position Description ,

Occupational Summary

Responsible for the oversight of research and day-to-day operations including finances and personnel management for the Brain Tumor Center Clinical Research Program of the Duke Cancer Institute DCI .

Collaborate closely with DCI Leadership, Finance and Human Resources, Duke Office of Clinical Research DOCR , School of Medicine SOM , Principal Investigators PIs and departments throughout the institution to carry out these responsibilities effectively.

Work Performed

Research Operations 40% of effort

Oversee study conduct including study initiation, IRB submissions and renewals, protocol initiation, participant recruitment, screening, consent and enrollment, data collection, safety reporting, study monitoring and audits, study closeout, and record retention and storage.

Assist with the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

Monitor the status of timelines and milestones for research studies to ensure timeliness, performance in accordance with all institutional standards, and compliance with Good Clinical Practice standards, Duke Policies and procedures, SOPs, and applicable regulatory requirements.

Provide updates and reports to leadership as required.

Conduct quality assurance audits. Oversee and participate in internal and external audits. Review and implement audit reports;

develop and implement corrective actions plans in response to identified problems.

Oversee compliance with institutional requirements pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance.

Connect study teams with stakeholders (e.g., statisticians) and institutional resources (e.g., ISO, IRB) to ensure data quality.

Ensure Quality Assurance processes are in place and followed.

Responsible for the implementation, adoption, and monitoring of new research technologies or systems and data capture requirements (e.

g. Oncore, Maestro Care, eReg, Advarra EDC etc.).

Financial 20% of effort

Collaborate on writing and implementing contracts and agreements.

Collaborate and work closely with the DCI Finance Team and assigned research programs on the feasibility of new studies including staffing requirements, clinical and logistical considerations, drafting budgets, and budget negotiation and payment terms, maximizing revenue, effort reporting and closing out studies.

Review financial reports to identify and implement solutions to budget-related issues. Bring in DCI leadership, PIs, research staff and others for discussions and solutions.

Manage and approve monthly staff effort in collaboration with the finance team.

Management 25% of effort

Responsible for requesting and managing clinical research system access for staff.

Continuously identify methods to improve CRU and institutional procedures and policies. Base decisions on data analysis collected via clinical research management systems.

Develop strategies to ensure implementation of institutional SOPs, policies, and initiatives.

Oversee the writing, implementation and maintenance of standard operating procedures SOP within the DCI CRU. Ensure staff are trained and knowledgeable in SOPs.

Oversee orientation and ongoing training for staff on your teams. Oversee the documentation of staff’s requited training and certifications.

Ensure staff identified by the e-IRB system as responsible for a given protocol qualify for the role and maintain their qualification.

Conduct and lead meetings for leadership, teams, and staff to ensure good communication, including goals. Effectively communicate new policies, regulatory updates, and institutional SOP changes.

Leadership 15 % of effort

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

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.

Oversee the fair and consistent application of human resource policies, and promptly address problems to manage your teams effectively.

Collaborate closely with DCI Human Resources and your manager on personnel issues; implementing policies, personnel file documentation and compliance.

Ensure your managers carry these out appropriately.

For direct reports manage their day-to-day assignments, work schedule, work location, approve time off requests, conduct yearly evaluations and goal setting, and actively engage in performance management including corrective action.

Serve as an expert resource on study-specific protocol requirements and problem solving for clinical, logistical, financial and regulatory issues.

Implement professional development and training programs to encourage staff retention, continuous improvement, and development (e.

g. DOCR : Research Professionals Network (RPN), Research Wednesdays).

Assist in the development and implementation of solutions at the institutional level to improve the research process. Use expertise and acumen to influence change within the DCI.

Demonstrate resilience, leadership, and actively facilitate change.

Ethics

Know and follow policies, standard operating procedures SOPs , regulations and protocol requirements that govern clinical research.

Maintain Duke and project specific training and certification requirements.

Basic Life Saving BLS certification from the American Heart Association or Duke approved equivalent course is a requirement of this position.

Other work as assigned.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position.

Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Qualifications Required At This Level

Minimum Qualifications

Education

Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.

Experience

Work requires a minimum of eight years of related experience, with at least five 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.

Nearest Major Market : Durham

Nearest Secondary Market : Raleigh