Associate, Clinical Operations (RID00214)

Associate / Senior Associate, Clinical Operations

Clinical Research | SS&A

Do 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 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

• Digital health or mobile application experience
• Experience in rare diseases, gene therapy, or long-term follow-up studies
• Knowledge of clinical drug development pathways, including Phase I-III studies and registries

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

Originally posted on Himalayas