Clinical Research Coordinator

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Provide leadership and coordination in the conduct of multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Thoracic Clinical Research Program [THRC].  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 40% Effort

• Employ strategies to maintain recruitment and retention rates, and assist participants with individual needs.  Collect information to determine appropriate study feasibility, recruitment and retention strategies.  Evaluate processes to identify issues related to recruitment and retention rates; offer solutions.
• Work closely with the Principal Investigator [PI] and study team to recruit, screen and enroll participants for studies.  Conduct and document consent for study participants.  Schedule participants and conduct visits for studies; conduct and document visits. 
• Coordinate study activities with teammates and colleagues to successfully implement and conduct the study.  Recognize and offer solutions to study problems. Escalate issues appropriately.  Take part in site initiation and closeout visits.  Assist in the development of new studies.
• Maintain study's compliance with institutional requirements and policies.  Maintain appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record.  Record adverse events [AE] and report promptly.  Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.     
• Assist with the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Research Data Security Plans [RDSPs].  Assist with the coordination of external monitoring boards.
• Follow procedures and documentation of study payment and participant care expenses in a timely fashion.  Monitor financial study milestones and report appropriately.  Coordinate with financial teams and participate in budget development.  Assist with study budgets and closeouts. 

Communication – 25% Effort

• Serve as primary liaison with sponsors, study personnel and PI for assigned studies.  Collaborate, and communicate with other study personnel as required. 
• Communicate concerns clearly in a professional manner.  Respond timely to emails, phone calls and questions. 
• Refer more complex questions and escalate issues to others as appropriate.  

Data – 25% Effort

• Use Electronic Data Capture [EDC] systems and enter data accurately.  Detect issues related to data capture, collection or management and suggest solutions. 
• Comply with required processes, policies, and systems to ensure data security and provenance.  Recognize and report vulnerabilities related to security of physical and electronic data.  Assist in investigating incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data. 

Leadership – 5% Effort

• Actively network.  Provide and support leadership within the team.  Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. 
• Encourage career development by actively seeking out continuing education opportunities.  Participate in scientific presentations and publications. 
• Serve as an expert resource for colleagues and teammates.  Mentor staff, including those in the same job title.  Support colleagues in their project work; encourage completion.  Participate and assist with the coordination of educational needs for ancillary staff as appropriate, for documentation needs, educational needs, to assist and ensure protocol compliance.

Ethics – 5% Effort

• Communicate to study staff and research participants the difference between clinical and research activities, and the risks and benefits of study participations.  Recognize when staff and patients are having difficulty with the distinction and work hard to help them understand the differences. 
• Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. 
• 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. 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.

Minimum Qualifications

Education

Completion of an Associate degree. Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requirement of this position. 

Experience

Work requires a minimum of two years of relevant research experience.  A Bachelor's degree may substitute for 2 years required experience.

Skills

Can easily use computing software and web-based applications [e.g., Microsoft Office products and internet browsers]. 

Preferences

The preferred candidate will have oncology or research experience, training, education or clinical trials coordination experience.   

Job Code: 00001201 CLINICAL RESEARCH COORDINATOR
Job Level: 52

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