Clinical Research Assistant | Evidence Generation

Location: On-site at NIH, Bethesda, MD (local candidates only) Engagement Type: Contract, 12 months, 40 hrs/week Function: Clinical Research / Evidence Generation About the Opportunity Our client is a clinical-stage biopharmaceutical company developing treatments for rare and ultra-rare genetic diseases, including Niemann-Pick Disease Type C (NPC). Our client has access to data from the NIH's long-running NPC Natural History cohort and is looking to generate evidence from this registry to support the understanding and treatment of NPC. This role will be embedded on-site at NIH, working closely with NIH's Study Coordinator and Nurse Practitioner on the natural history cohort, to pull and analyze registry data on behalf of our client in support of defined evidence gaps and research questions. The Role The primary focus of this role is evidence generation for our client. The Clinical Research Assistant will support NIH's natural history team day to day while working to extract and analyze registry data on patients enrolled in the NPC Natural History cohort, specifically examining how the disease has progressed in patients who have not received treatment. The goal is to better understand the natural course of the disease in order to prepare data and materials that support our client's publication efforts, including manuscripts and posters led by our client's Medical Affairs and Evidence Generation teams. This role will not be responsible for writing manuscripts, but will play a key role in extracting and preparing the underlying data and literature support. Key Responsibilities Work on-site at NIH alongside the Study Coordinator and Nurse Practitioner supporting the NPC Natural History cohort Pull and analyze data on patients enrolled in the registry, on behalf of our client, with a focus on how untreated patients' disease has progressed over time Extract data to support a deeper understanding of NPC disease characteristics and course Prepare extracted data and literature support for use in our client's publications, manuscripts, projects, and posters Support evidence generation aligned to defined research questions and evidence gaps identified by our client's Medical Affairs team Serve as the on-site liaison between our client and NIH for data requests Assist with day-to-day coordination support for the assigned protocol as needed Maintain compliance with NIH institutional requirements, data systems protocols, and applicable regulatory standards Qualifications Scientific background required Prior clinical research, clinical trial, or clinical data experience preferred; strong candidates with relevant administrative/healthcare experience will also be considered High attention to detail and comfort with high-volume, accurate data extraction and analysis Strong organizational skills and ability to work independently on-site Ability to work effectively as part of a multidisciplinary research team Must be local to the Bethesda, MD area and able to work full-time, on-site at NIH Must be able to obtain and maintain required NIH security clearance and system access prior to start (approximately 6-week process) #J-18808-Ljbffr Meet Life Sciences