Associate, Clinical Operations (RID00214)
TypeFull-time job
LocationUnited States
Posted2 hours ago
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.
To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.
Originally posted on Himalayas
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.
To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.
Originally posted on Himalayas
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