Clinical Research Associate

Spectraforce Technologies
United States, North Carolina, Raleigh
500 West Peace Street (Show on map)
May 20, 2025
Position Title: Clinical Research Associate 18 Months (Possibility of extension) 100% Remote Description: Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. What are the top 3-5 skills, experience or education required for this position: Medical Device Experience Attention to Detail Great Communication Skills Phase IV Experience Q: What is the travel expectation for this CRA II role? A: Travel is expected to be about 30%. Most of the visits will be onsite with minimal remote monitoring. Travel is not strictly tied to study timepoints, except for initial visits, which are time-sensitive. Other visits can be scheduled with flexibility. Sites will be regionally assigned based on the CRA's location. Q: Is medical device or aesthetic medical device experience required? A: Medical device experience is required, but aesthetic-specific experience is not necessary. They are open to CRAs from other medical device backgrounds. Q: What is the day-to-day responsibility of the CRA? A: The CRA will be primarily responsible for direct site monitoring, managing site interactions, ensuring visits are scheduled and completed appropriately, and ensuring protocol compliance. The role is strictly technical and site-facing. There will be close coordination with site managers to ensure everything is running smoothly. Q: Is Phase IV experience mandatory? A: Phase IV experience is preferred, but strong CRA and medical device monitoring experience is more important.