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] Multisite Trials Service Center (MiSTiC) in the Oncology Clinical Research Unit, which oversees the conduct of DCI clinical research.

Work Preformed

Operations, Study and Site Management – 60% Effort

• Employ strategies to maintain recruitment and retention rates across all participating sites and assist with individual site needs as appropriate. Collect information from external sites to determine appropriate study feasibility, recruitment, and retention strategies. Evaluate processes to identify issues related to recruitment and retention rates at all participating sites; offer solutions as appropriate.
• Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
• Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
• Coordinate study activities with teammates and colleagues to successfully steer the Duke study start up processes, navigate regulatory approvals, activate participating sites, manage and monitor the conduct of multisite studies. 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.
• Work closely with the Principal Investigator [PI] and study team to monitor recruitment, screening and enrollment of participants across all participating sites. Collect documentation of informed consent process, eligibility verification and enrollment and study visits of participants as appropriate. Track biospecimen collection, processing, storage and shipping across labs and maintain the master specimen log.
• Initiate, manage and maintain the Duke regulatory application for multisite studies; monitor and manage regulatory documentation from external sites. Maintain study's compliance with institutional requirements and policies. Oversee continuing renewals and amendments approvals. Maintain appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Track and maintain Deviation Logs across all participating sites.
• Assist with the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Duke Research Data Lifecycle (DRDLs) as appropriate. Assist with the coordination of monitoring visits for all participating sites.
• Follow procedures and documentation to aid in the payment of external site invoices. Monitor financial study milestones and report appropriately. Coordinate with financial teams and participate in budget development for multisite studies. Assist with study budgets and closeouts.
  
  

Communication – 15% Effort

• Serve as liaison with participating sites, study personnel and PI for multisite 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.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
  
  

Data – 10% Effort

• Use Electronic Data Capture [EDC] systems to oversee and manage data collection. 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 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.
• Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change.
  
  

Ethics – 10% Effort

• Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
• 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.
• Communicate to study staff the difference between clinical and research activities, and the risks and benefits of study participations. Recognize when staff 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.
  
  

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's degree

Experience

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

Preferences

• The preferred candidate will have oncology or research experience, training, education, or clinical trials coordination experience.
• Regulatory experience preferred but not required including regulatory management skills for example IRB approvals, knowledge of iRIS, and Oncore and knowledge of institutional SOPs at the least.
• Multisite regulatory experience preferred but not required.
  
  

Job Code: 00001201 CLINICAL RESEARCH COORDINATOR

Job Level: 52

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