Senior Clinical Research Specialist, Duke Cancer Institute

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.

Senior Clinical Research Specialist, Duke Cancer Center 

Oncology Clinical Research Unit [CRU]

Leukemia Clinical Research [BMT-Heme]

Position Description, 

Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute’s [DC] Leukemia Clinical Research Program. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 20% Effort

Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others. Follows SOPs. Under supervision, employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with maintenance of study level documentation. Participates in study team meetings.

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. Prepares studies for closeout and document storage. May train or oversee others.

Communication – 15% of Effort

Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Respond to routine questions related to study protocol and refer more complex questions or escalate issues to others as appropriate. 

Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. 

Data – 50% of Effort

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. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance.  In addition, recognizes and reports security of physical and electronic data vulnerabilities. Documents and maintains documentation to facilitate data sharing during publication or study closeout. Knowledgeable about the use of data standard policies. Under supervision, performs de-identification on allowable data to Safe Harbor standards. Innovatively uses technology to enhance a research process. May train others. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators.

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. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary  to get work done efficiently. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Trains others to communicate effectively within teams. Facilitates resolution of issues associated with teams or communication.
 

Ethics – 10% of Effort

Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record). Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.
 

And other work as assigned. 

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.  Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. 

Preferences

Bachelor's Degree is strongly preferred.

Qualifications Required At This Level

Link to view the education, experience and skills required for the 0803 Clinical Research Specialists, Senior classification: https://forms.hr.duke.edu/descriptions/university/select.php?ID=0803

Minimum Qualifications

Education

Work requires an Associate's degree.

Experience

One year of relevant experience. A Bachelor's degree may substitute for required experience.

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.

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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.