This position will help coordinate the day-to-day operations of a pediatric sleep and attention-deficit/hyperactivity disorder (ADHD) research study. The overarching purpose of the research study is to better understand causes of sleep disturbances among children with ADHD during the peak period of referral and diagnosis (ages 6-9) and how sleep and circadian problems contribute to clinical and cognitive presentations in ADHD.
Study procedures involve wearable sensors to measure sleep and in-lab dim light melatonin collection to measure circadian functioning, as well as collection of a range of clinical and cognitive measures in the participants. The study team will also have regular collaboration with RTI International, a nonprofit research institute located in Durham, N.C. dedicated to improving the human condition. Candidate will be involved in recruitment and enrollment of participants, running study visits, and data management.
This position will be a hybrid of remote work with in-person participant sessions at our Durham office location; a flexible schedule allowing for evening and weekend availability for participant sessions is required.
Operations: Ideal candidate recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Conducts activities for study visits in compliance with the protocol. May train staff. Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.
Ethics: Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others. Assists with the development of consent plans and documents for participants. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.
Data: 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. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Knowledgable about requirements for depositing data and following repository and meta-data specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing. Maps a protocol’s data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. 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 reports on study progress for the PI and other study team members and collaborators.
Science: Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. Using scientific proposals from the PI, develops elements of research protocols. Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications.
Study and Site Management: Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.
Leadership: Proactively seeks opportunities to add relevant skills and certifications to own portfolio. 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. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Description of Portfolio Responsibilities: (Effort .%):
(Effort .75%): Recruitment, data collection (study interviews, computerized assessments), data management, and management of clinical research specialist senior and undergraduate research assistants.
(Effort .25%): Maintain regulatory documentation, coordination of study activities with RTI International, assist with progress reports to sponsor/funder.
Special skills: Experience with or willingness to learn REDCap software is required.
Required Qualifications at this Level
Education/Training
Completion of an Associate’s degree
Experience
Work requires a minimum of two years of relevant research experience. A Bachelor’s degree may substitute for 2 years required experience.
Skills
Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
Minimum Qualifications
Education
Completion of an Associate’s degree
Experience
Work requires a minimum of two years of relevant research experience. A Bachelor’s degree may substitute for 2 years required experience.
