Psychiatry - Clinical Research Specialist, Sr. - Child Division - Lunsford-Avery Lab

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:
Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Assists with maintenance of study level documentation. 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. Participates in study team meetings.

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).

Data:
Enters and collects basic data for research studies. May score scripted or validated tests and measures. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance. Learns and uses new technology when required.

Science:
May assist with simple literature searches under supervision from PI or CRC. Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship).

Study and Site Management:
Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Ensures that studies are conducted in compliance with institutional requirements and other policies. 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).

Leadership:
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.). 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 100%): Recruitment, data collection (study interviews, computerized assessments), and data management.

Type of Research:
 

This position will assist with coordination of 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 wearabl