Do you enjoy managing complex clinical studies while helping bring innovative research technologies to patients and sites?
We're seeking an 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: 0-5 years
Required Qualifications
Undergraduate degree or equivalent professional experience
Experience operationalizing clinical study protocols, amendments, observational research studies, and registries
Professional experience within biotech, pharmaceutical, CRO, clinical site, or consulting environments
Knowledge of GCP, ICH, HIPAA, GDPR, FDA requirements, and clinical research regulations
Experience managing multiple research projects, vendors, sponsors, sites, and stakeholders simultaneously
Working knowledge of EDC, ePRO, EHR, and clinical research technologies
Strong written and verbal communication skills and proficiency with Microsoft Office (Word, Excel, PowerPoint)
What You'll Do
Support studies from startup through closeout
Manage sponsor, site, and vendor relationships
Participate in protocol design discussions and implementation planning
Develop IRB submission packages, training materials, caregiver/site manuals, and operational documentation
Lead or support Site Initiation Visits (SIVs), site training, and central rater training
Partner with Data Management, Product Management, and Technical Delivery teams
Support UAT and product launches
Nice to Have
0-5 years of experience in clinical research, project management, or related life sciences settings
Experience supporting rare disease, gene therapy, or long-term follow-up research programs
Experience working with sponsors, CROs, and external vendors
Exposure to digital health, mobile applications, or technology-enabled clinical research solutions
Understanding of clinical drug development, including Phase I-III clinical trials, registries, and observational studies
Strong problem-solving, communication, and collaboration skills, with the ability to work effectively in a team-based environment
Diversity, 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.
Use of Artificial Intelligence (AI) Notice: Red Nucleus may use artificial intelligence (AI) tools to assist in reviewing applications and assessing candidate qualifications against job requirements. We are committed to fair and inclusive hiring practices, with appropriate human oversight of AI-assisted decisions. Candidate information is handled in accordance with applicable privacy laws. For questions about our use of AI or to request an accommodation or alternative assessment, please con [email protected]
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