Associate, Clinical Operations

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 removed]

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.

#LI-KS1