Associate, Clinical Operations

Associate / Senior Associate, Clinical OperationsDo you enjoy managing complex clinical studies while helping bring innovative research technologies to patients and sites?We're seeking an Associate / Senior Associate, Clinical Operations to support clinical research studies, including programs utilizing remote data capture technologies such as video assessments, ePRO, and eCOA solutions.Experience Level: 1-10 yearsRequired QualificationsUndergraduate degree or equivalent professional experienceExperience operationalizing clinical study protocols, amendments, observational research studies, and registriesProfessional experience within biotech, pharmaceutical, CRO, clinical site, or consulting environmentsKnowledge of GCP, ICH, HIPAA, GDPR, FDA requirements, and clinical research regulationsExperience managing multiple research projects, vendors, sponsors, sites, and stakeholders simultaneouslyWorking knowledge of EDC, ePRO, EHR, and clinical research technologiesStrong written and verbal communication skills and proficiency with Microsoft Office (Word, Excel, PowerPoint)What You'll DoSupport studies from startup through closeoutManage sponsor, site, and vendor relationshipsParticipate in protocol design discussions and implementation planningDevelop IRB submission packages, training materials, caregiver/site manuals, and operational documentationLead or support Site Initiation Visits (SIVs), site training, and central rater trainingPartner with Data Management, Product Management, and Technical Delivery teamsSupport UAT and product launchesNice to HaveDigital health or mobile application experienceExperience in rare diseases, gene therapy, or long-term follow-up studiesKnowledge of clinical drug development pathways, including Phase I-III studies and registriesDiversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.