Clinical Research Specialist, Senior - 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.

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 (DCI) Bone Marrow Transplant, Hematology Malignancies & Cellular Therapy Clinical Research Program (BMT) 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 – 45% Effort

Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with maintenance of study level documentation. Prepares documents, equipment, supplies, etc. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews.

Participates in study team meetings.

As directed, attends or schedules site visits. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Communication – 40% 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 – 5% of Effort

Follows required processes, policies, and systems to ensure data security and provenance. Learns and uses new technology when required.

Leadership – 5% Effort

Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). 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. Communicates with other study personnel as required for study implementation and routine problem resolution. 

Ethics – 5% of Effort

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.  Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations.  Understand that the safety of research participants is a priority.  Identify and explain the risk and benefits for a clinical trial. 

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. 

Basic Life Saving (BLS) certification from the American Heart Association or Duke approved equivalent course is a requirement of this position. 

Under supervision may collect information about AEs, identified in the protocol or investigator brochure.

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. 

Qualifications Required At This Level

Education

Work requires an Associate's degree.

Experience

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

Preferences

Preferred skills include excellent technical and communication skills, organization, time management, and can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $20.76 to USD $31.44. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at https://hr.duke.edu/benefits/

Job Code: 00000803 CLINICAL RESEARCH SPECIALIST, SR
Job Level: 09

Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military 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 essential job 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.