Associate, Clinical Operations (RID00214)

Red Nucleus; Yardley (Bucks County); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Strong communication skills

MS Office proficiency

Formation

Undergraduate degree or equivalent

Outils

EDC

ePRO

EHR

Description du poste

Associate / Senior Associate, Clinical Operations

Clinical Research | Red Nucleus

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.

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus. #LI-KS1