Senior Clinical Operations Associate | Study Launch & Tech

Red Nucleus; Yardley (Bucks County); On-site; USD 90,000 - 130,000; Full time

Job summary

Red Nucleus is seeking an Associate/Senior Associate, Clinical Operations to support complex clinical studies, including programs with remote data capture like video assessments, ePRO, and eCOA solutions, in the United States.

The ideal candidate will coordinate sponsor, site, and vendor relationships, contribute to protocol design, prepare IRB submissions, training materials, and operational docs, and collaborate with Data Management and Product teams to support UAT and product launches.

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).

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

Strong communication skills

MS Office proficiency

Education

Undergraduate degree or equivalent

Tools

EDC

ePRO

EHR

Job description

Red Nucleus is seeking an Associate/Senior Associate, Clinical Operations to support complex clinical studies, including programs with remote data capture like video assessments, ePRO, and eCOA solutions, in the United States.

The ideal candidate will coordinate sponsor, site, and vendor relationships, contribute to protocol design, prepare IRB submissions, training materials, and operational docs, and collaborate with Data Management and Product teams to support UAT and product launches.