This Position is Partially Grant Funded

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.

This Position is Partially Grant Funded

Occupational Summary

Develop, coordinate, and implement research trials, financial solvency, expansion of Duke Cancer Institute’s [DCI] clinical trials (CT) throughout the Duke University Health System [DUHS] network (regional, national and global); including recruitment and strategies essential to the successful management of Phase I, II, and III clinical trials research projects conducted by principal investigators [PIs]. Responsibilities include complicated grant submissions, fiscal, coordination and organization, documentation and compilation of clinical research requirements including harmonization of trials in non-US and Canadian countries. Leadership and oversight of assigned research programs and staff.

Work Preformed

Program and Strategic Initiatives – 50% Effort

Develop, coordinate, and implement research and administrative strategies to manage Phase I, II, and III clinical trial research projects including the organization, documentation and compilation of clinical research data.

Implement strategic initiatives to expand clinical trials through the DUHS networks (regional, national and global), recruitment and cooperative strategies for Phase I, II, and III clinical trials and management of multi-site trials under these initiatives. Lead study feasibility, design, protocol development, and recruitment and retention strategies for clinical trials. Implement cultural diversity and competency in study design and conduct.

Collaborate and facilitate the completion, documentation and submission of grants. Oversee the execution of NCI cooperative grants.

Assist PIs and staff in the development of subject recruitment strategies, identify barriers to enrollment, and implement appropriate interventions.

Assist PIs and staff in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate. Recommend guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist in the determination of guidelines for new protocols.

Confer with coordinators and others to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration, NCI and protocol guidelines; identify potential problems and inconsistencies them take the appropriate action. Provide oversight and training regarding subject screening, consent, regulatory compliance and documentation; including sponsorship and participation in trials.

Oversee development of safety and security documents such as research data storage plans [RDSP], conflict of interest [COI], and data safety management plans [DSMP]. Oversee the Institutional Review Board [IRB] process including documents and communication. Lead development of policies, reporting and documentation for monitoring, audits, adverse events and research specimens.

Lead development of policies, reporting and documentation for monitoring, audits, adverse events and research specimens. Lead and train compliance with institutional requirement and policies including sponsor specific.

Detect issues related to data capture, collection or management; design and implement improvements.

Lead the required processes, policies, and systems to ensure data security and provenance. Lead the creation of electronic case reporting forms, electronic data capture systems, technologies and software to ensure the highest quality data collection and capture. Develop the systems and framework for quality assurance and security.

Leadership – 15% Effort

Serve as an expert resource for colleagues, other departments, outside agencies and the research team on professional guidelines and code of ethics related to the conduct of clinical research, study-specific protocol requirements and problem solving for clinical, logistical, financial and regulatory issues.

Lead team meetings, committees, task forces and ad hoc groups at the department and institution level. Lead cross-functional committees charged with improving study design. Provide significant contributions to research and projects across multiple groups. Independently lead scientific, programmatic presentations and publications.

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

Coordinate orientation and ongoing training for research staff at assigned sites. 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.

Supervisory – 20% Effort

Define the vision and direction of the research team. Lead, supervise and manage staff including coaching, time-off, annual performance review, performance management, career development, training, hiring and terminations. Model the DCI’s core value “Cancer Care as It Should Be” for staff. Create a team culture that fosters open communication, motivates staff, and encourages creativity. Seek out, listen to, accept and act on feedback. Establish regular communication methods and meetings with staff; collectively and individually. Be available to staff on a routine basis to provide leadership and mentoring.

Provide staff with clear measureable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as needed to effectively conduct clinical research. Foster and encourage the professional development of staff. Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.

Financial – 15% Effort

Partner and collaborate with the Finance Team to:

Ensure managers and staff work closely and collaboratively with the Finance Team to set-up, review and close studies:

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.

Other work as assigned.

Skills

Ability to effectively collaborate and communicate with diverse communities to move projects forward. Ability to manage and prioritize multiple projects effectively.

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.

Preferences

The preferred candidate will have experience in research and medical writing.

Qualifications Required At This Level

Education/Training

Completion of a bachelor degree plus a minimum of eight years of research experience.

Experience

Work requires a minimum of eight years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.

Skills

Can easily use computing software and web-based applications [e.g., Microsoft Office products and the electronic medical record].

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.