CLINICAL RESEARCH SPECIALIST, SR

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

Performs a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator or similar Clinical Research Units (CRU),Oversight Organization (OO) designee. Participates in day-to-day operations related to the collection, compilation, and documentation of clinical research data and may train Clinical Research Specialists (CRS) in these tasks.

Work Performed

Research Operations

• Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering) and prepares for study monitoring and audit visits.
• Maintains participant level documentation for non-complex (e.g., questionnaires, data registry, scripted) studies outside of the EHR.
• Recruits research participants according to study protocol and follows standard operating procedures (SOPs) and strategies to manage and retain research subjects.
• Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the electronic health record (EHR) to assist study team in determining eligibility.
• Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
• Assists with maintaining and establishing study level documentation; may perform for international studies.
• Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment.
• Follows SOPs and participates in study team meetings. Safety and Ethics
• 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). Assists with the development of consent plans and documents for participants.
• Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review.

Data

• Enters and collects basic data for research studies. May score scripted or validated tests and measures.
• Assists with quality control and data cleaning as directed.
• Independently responds to queries created by a CRO or the data manager.
• Independently corrects and documents incomplete, inaccurate, or missing data for non complex studies and follows SOPs for quality assurance. Runs summaries and reports on existing data.
• 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.
• For non complex protocols, identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. Knowledgeable about the use of data standard policies.
• Learns and uses new technology when required.
• 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.
• Under supervision, executes testing process after the completion of a build, or following any project changes or system upgrades and may conduct some testing and documentation for Part 11 projects.

Scientific Concepts

• Assists with simple literature searches.
• Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies).
• Provides some contribution to scientific publications or presentations (no authorship).

Site and Study Management

• As directed, attends or schedules site visits and assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
• Records participant accrual information and consent documentation for non-complex studies, and basic protocol information in clinical research management system.
• 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. Leadership and Professionalism
• 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 departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).
• Communicates with other study personnel as required for study implementation and routine problem resolution.

Required Qualifications at this Level

Education/Training:

Experience:

Skills:

Work requires an Associate's degree.

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

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

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.

Duke University 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.

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.

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.

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 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.