Associate, Clinical Operations (RID00214)

Red Nucleus; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

Red Nucleus in the United States is seeking an Associate / Senior Associate, Clinical Operations to support clinical studies from startup through closeout. The role involves managing sponsor, site, and vendor relationships and helping implement protocols and operational documentation.

You'll work with remote data capture tech such as video assessments, ePRO, and eCOA, contributing to UAT and product launches with cross-functional teams. 1–10 years of experience preferred.

Qualifications

• Experience operationalizing clinical study protocols and registries.
• Experience in biotech, CRO, or sponsor environments.
• Knowledge of GCP, ICH, HIPAA, GDPR, FDA requirements.

Responsibilities

• 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.

Skills

GCP knowledge

Communication

Vendor management

Project coordination

EDC knowledge

Regulatory knowledge

Education

Undergraduate degree or equivalent

Tools

EDC

EHR

Microsoft Office

Job description

Location: United States

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

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.