Psychiatry - Clinical Research Coordinator - Behavioral Med - Sahlem 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.

The Duke Psychiatric Advanced Clinical-Translational Idea Lab (PACTiLab) utilizes a multidisciplinary collaborative team to focus on the translational development of new treatments for psychiatric illnesses (with a special emphasis on addictive and mood disorders). Our mission is to take mechanistic ideas into the clinical-research setting in the hopes of traversing the translational bridge (performing human laboratory trials, translational treatment trials from phase-1 to phase-3, and research aimed at more directly improving clinical care).

Our group embraces the tripartite academic medicine mission. Lab-members are subsequently encouraged to advance science through research, teach what they know, and improve clinical care through treatment trials. The lab has expertise in the use of neuromodulation techniques including repetitive Transcranial Magnetic Stimulation (rTMS) and electroconvulsive therapy (ECT), but is agnostic regarding treatment modality, focused rather on any intervention that has the potential to improve how we treat psychiatric disorders.

We are excited to invite three new junior-colleagues to join a soon to be started project that is designed to improve our understanding of the neural-circuitry underling the addictive process in opioid use disorder. The project is investigating a candidate biomarker that we hypothesize might help us understand why a given patient responds well to buprenorphine (the most commonly used medication to treat opioid use disorder), while others might not. We are additionally investigating the efficacy of delivering a course of accelerated rTMS to a personalized brain target developed using functional magnetic resonance imaging.

If you are interested in exploring the underlying pathophysiology of addiction and testing both a candidate biomarker and rTMS to see if they can improve clinical outcomes, this might be the team to join!

There will be opportunities to learn:

• Clinical trial design and conduct.
• Administering and processing functional Magnetic Resonance Imaging.
• Administration of repetitive Transcranial Magnetic Stimulation (rTMS).
• Clinical-participant screening and assessment.
• Presentation preparation and manuscript writing.
• General scientific processes including behavioral data analysis.
• Literature searches and summary.
• Other research and clinical skills.
• Of note, there will be protected time for mutually agreed upon career development projects and learning opportunities as above.

Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. 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. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Pr