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.

Operations: 

For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Oversees the management and documentation of investigational products (IP) for multiple study teams/research program. Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing. Serves as an expert resource for multiple study teams/research program for participant retention. Liaises with other resources at Duke to optimize retention rates. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals. Provides training. Screens participants for all studies, including those that are complex in nature(e.g.,procedural and interventional studies). Provides oversight and training in screening activities to multiple study teams. Develops or helps develop SOPs. May train or oversee others. Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program. Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans. Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies. 

Ethics: 

Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information. Provides 

oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. 

Data: 

For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs ECRFs and EDCs to collect data according to protocol. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke. Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and data provenance. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant. 

Science: 

Assists with or contributes to the development of funding proposals. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. 

Study and Site Management: 

Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Collects appropriate information to determine whether the study team's participation ina specific trial is feasible. May make recommendations. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies. Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies. Oversees implementation of operational plans across research program, including at multiple sites. Develops and implements closeout procedures for multiple studies across multiple teams. 

Leadership: 

Encourages staff to take part in professional development opportunities. Provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.). Plays key role on committees and workgroups. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized toimprove research process. Actively facilitates and leads multiple study team's adoption of change in their working environment. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. Trains others to communicate effectively within teams. Facilitates resolution of issues associated with teams or communication.

Work requires an Associate's degree.

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

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