Clinical Research Specialist, Sr. - Psychiatry - Carpenter Team

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 Specialist, Sr. – Psychiatry - Carpenter Team

Operations: (25%)
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. 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, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). 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 effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

Ethics: (10%)
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.

Data: (25%)
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. Maintains study-level documentation for all studies, including those that are complex in nature (e.g., involving datasets from multiple sources, big data, or non-standardized data). Provides oversight and training and lends expertise to multiple study teams. 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. For multiple study teams, provide guidance on the use of data standards. Provides training and oversight into EDC creation using appropriate data standards. For studies reporting to the FDA, coordinate the CDISC and CDASH data standard setup and the CDISC dataset transformation tasks. Under supervision, performs de-identification on allowable data to Safe Harbor standards. 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. Innovatively uses technology to enhance a research process. May train others. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.

Science: (10%)
Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals. Demonstrates and applies a basic understanding of open science practices and the FAIR data principals. Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams. Uses expertise in research design to provide significant contribution to protocols or research proposals. Provides significant contribution or leadership on accepted, peer-reviewed publication or conference presentation.  Mentors others in this area.

Study and Site Management: (20%)
Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across multiple study teams or sites. Develops and implements closeout procedures for multiple studies across multiple teams.

Leadership: (10%)
Encourages staff to take part in professional development opportunities. 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. 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.

Type of Research:
Studies are recruiting autistic children, neurotypical children and children with autistic siblings. Study tasks include remote surveys, in-person diagnostic assessments, EEG, observational assessments, and completing study application. This person manages and supports 4 CRS Srs and 6 undergrad students