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

Responsible to the Duke Cancer Institute (DCI) for the day-to-day operations and finance related to study conduct of assigned study teams. Ensure research staff are performing activities in accordance with good clinical practice, CRU standards, Institutional Policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring. Collaborate closely with the Principal Investigators (PIs) DCI Leadership, Finance and Human Resources, Duke Office of Clinical Research and departments throughout the institution to carry out these responsibilities effectively.

Work Performed

Management and Leadership

Provide leadership and management to staff in the reporting structure within the scope of practice. Managers are accountable for their direct reports.

Coordinate orientation and ongoing training for research staff. Maintain current records for requited training and certifications. Central administration will provide periodic reports to identify key personnel on each study. Ensure all research staff identified by the e-IRB system as responsible for a given protocol qualify for the role and maintain their qualification.

Serve as an expert resource to PIs, research staff, other departments and outside agencies on study-specific protocol requirements and problem solving for clinical, logistical, financial and regulatory issues.

Assist PIs and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

Collaborate closely with DCI Human Resources on personnel issues; implementing policies, personnel file documentation and compliance. Ensure your managers carry these out appropriately.

Study Conduct

Manage the day-to-day operations related to study conduct including IRB submissions and renewals; protocol initiation; participant recruitment, screening, consent and enrollment; safety reporting; and study close-out, record retention and audit ready files stored.

Monitor the status of timelines and key milestones for clinical research studies including contract execution, IRB approval, enrollment, etc.

Ensure managers and their staff carry out study activities including:

IRB protocol submissions, amendments and renewalsInitiate studiesRecruit, screen, consent, enroll and follow-up with research participants; collect data and resolve queriesSupervise monitoring visitsPerform safety reportingEnsure study drug compliance & drug accountabilityCommunicate research issues within and outside the departmentClose out studies timely and ensure retention of records per Duke and sponsor policyResearch activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, and applicable regulatory requirementsSubjects are entered into Clinical Trials Management System (CTMS) in a timely and accurate mannerMonitor the progress of start-up timelines for new studies, including IRB approval, contract negotiations, budget & payment terms negotiation and development of the charge assignment grid, while providing regular updates to DCI LeadershipMonitor the progress of ongoing studies including enrollment, data collection, and close-out, while providing regular updates to DCI Leadership and other related research activities as determined by day to day operationsCompliance and Audits

Accountable for performing activities in accordance with all institutional standards for study conduct, and more specifically those relating to clinical research, providing information to the central School of Medicine departments as needed.

Participate in audits of studies by internal and external authorities. Review and respond to audit reports, develop solutions and implement corrective action in a timely manner for identified problems.

Ensure standard operating procedures are up-to-date standard; staff are knowledgeable regarding SOPs, document staff’s knowledge of SOPs and ensure all activities comply with SOPs.

Conduct CRU QA audits.

Financial

Facilitate completion of DCI related national grants documentation and submission. Oversee execution of grants.

Collaborate and work closely with the DCI Finance Team to:

Provide training and advice to PIs and research staff in the negotiation of study budgets and payment terms with sponsorsEvaluate the feasibility of new studies including staffing requirements, clinical and logistical considerations, and competing studiesIdentify and implement strategies to maximize revenue and close out studies promptlyReview financial reports prepared by the Finance Team; identify and assist in rolling out solutions to budget-related issues. Bring in DCI leadership, PIs, and research staff to discussions and solutions as appropriateEnsure managers and staff work closely and collaboratively with the DCI Finance Team to set-up, review and close studies:

Provide input into financial feasibility of each new study by providing study plan details for the development of an internal cost summaryAssist with budgets and budget negotiationsReview and evaluate the charge assignment grid based on the schedule of events and protocolMaintain accurate effort records and submit changes timelyRegularly review reports prepared by the Finance Team; and assist the Finance Team to address budget-related issues and implement solutionsOther 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

Education/Training

Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least five years in a research setting. ACRP or SOCRA preferred; OR RN or Bachelor's degree and 6 years of related experience, with at least five years in a research setting. ACRP or SOCRA preferred; or Master's degree and 4 years of related experience, with at least three years in a research setting. ACRP or SOCRA preferred.

Experience

No experience is required beyond what is specified above.

Preferences

The preferred candidate will have national grant writing experience and experience overseeing research trials, training, and education.

Duke University 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 essential job 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.