Associate, Clinical Operations

Red Nucleus

. Support studies from startup through closeout .

Posted 10/22/2026full-timeRemote • Pennsylvania • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical studies from startup to closeout, including protocol design, IRB submissions, and vendor relationships. Proficient in navigating clinical research regulations and technologies while effectively communicating with stakeholders.

Highest-signal resume keywords

Clinical Study Protocol OperationalizationGCP KnowledgeEDC ExperienceMicrosoft Office ProficiencyVendor Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research RegulationsProtocol DesignIRB Submission DevelopmentProject ManagementObservational Research StudiesClinical Drug Development PathwaysData ManagementUAT SupportDigital Health ExperienceGene Therapy Knowledge

Soft Skills

Strong Written CommunicationStrong Verbal Communication

Tools & Technologies

EDCEPROEHRMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

BiotechPharmaceuticalCROClinical SiteConsultingHIPAAGDPRFDA RequirementsRare DiseasesLong-Term Follow-Up Studies

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Undergraduate degree or equivalent professional experience
1–10 years of 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
Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Digital health or mobile application experience preferred
Experience in rare diseases, gene therapy, or long-term follow-up studies preferred
Knowledge of clinical drug development pathways, including Phase I–III studies and registries preferred

Benefits

Comp & perks

Equal opportunity employment
Inclusive workplace culture
Diversity, equity and inclusion valued
No discrimination based on race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status