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.
Clinical Research Coordinator [CRC]
Oncology Clinical Research Unit [CRU]
Brain Tumor CLINICAL [BTC]
Position Description ,
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] Cancer Population & Population Services Clinical Research Program [CCPS]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Work Preformed
Operations, Study and Site Management - 40% Effort
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, and SOPs. May train others in these policies and processes. Prepares for and provides support for study audit visits, including support for the reviewer. Prepares for DCI routine Monitoring Visits (DCI MV) and serve as point of contact for the DCI Monitoring Team (MT) and Safety Oversight Committee's (SOC's) expectations. Addresses and corrects findings.
Maintains participant level documentation for all assigned studies, and/or require access to the Duke EHR.
Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for minimal risk studies.
Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Act as clinical liaison between Surgical, Biorepository and Clinical Research teams to coordinate tissue and biospecimen collection for IRB approved protocols within PRTBTC. Run reports to identify and prescreen eligible patients to be presented with a consent forms for tissue bank studies.
Build and maintain daily schedule to coordinate in-clinic or eConsent by data staff for the potential patients identified.
Track patients who consented across different platforms: Spreadsheets, Enrollment logs, REDCap or other platforms that may be established in future.
Maintains spreadsheets and Enrollment logs for biospecimen collected for tissue banking studies for current IRB approved protocols and future research.
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.
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.
Collaborate to develop REDCap database for data capture for minimal-risk studies.
Reconcile spreadsheets with Oncore, REDCap and Master Biospecimen Trackers for all tissue banking studies.
Coordinate and implement procedures to collect IRB approved data from patient charts, medical records, archival records, interviews, questionnaires, and other sources; code, evaluate and interpret collected data and prepare appropriate documentation. Ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitor patients' progress.
Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). Under supervision, develops validation and testing scripts for EDCs for new studies. Executes testing process after the completion of a build, or following any project changes or system upgrades. Follows policy related to 21 CFR Part 11 compliance, and under supervision may conduct some testing and documentation for Part 11 projects.
Provide data in response to "Data Pull requests" by clinicians/researchers for IRB approved protocols in a timely manner. Develops reports on study progress for the PI and other study team members and collaborators. Prepares data for deposit in repositories following publication or study closeout.
Prepares tables, data visualizations, and lay summaries to communicate study results with participants.
Identifies data retention requirements that apply to the study from funders, data providers, and/or the institution. Follows applicable data retention and destruction requirements. May train or oversee others.
Creates clear visualizations to help communicate key information to stakeholders.
Under direct supervision from Biostatistician and PI may perform basic analyses on structured data. Under supervision, performs de-identification on allowable data to Safe Harbor standards.
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
Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. 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. 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.
Actively network. Provide leadership within the team. Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. Participate in scientific presentations and publications.
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.
Follow SOPs to conduct and document consent for participants for minimal risk studies. Assists with the development of consent plans and documents for participants. 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.
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. Preferences
The preferred candidate will have oncology or research experience, training, education or clinical trials coordination experience. The ideal candidate is detail oriented, organized, a self-starter, and a fast learner with the ability to multi-task and work quickly. Clinical data management, EMR and Oncore exposure and experience preferred. Experience in a patient-facing environment preferred.
Qualifications Required At This Level
Link to the required education, training, experience and skills required for a 1201 Clinical Research Coordinator classification: https://forms.hr.duke.edu/descriptions/university/select.php?ID=1201
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.
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