Associate, Clinical Operations (RID00214)

Red Nucleus • Yardley, PA

3d

About The Position

Red Nucleus is seeking an Associate, Clinical Operations to support clinical research studies, including programs using remote data capture technologies such as video assessments, ePRO, and eCOA solutions. The role supports studies from startup through closeout and involves coordinating sponsors, sites, vendors, and internal teams. The associate may contribute to protocol design and implementation planning, prepare operational and regulatory materials, support site and rater training, and assist with user acceptance testing (UAT) and product launches.

The position is listed at an experience level of 0–5 years. Red Nucleus values diversity, equity, and inclusion and states that it provides equal opportunity and does not discriminate on the listed protected grounds. The company may use AI tools to assist with application review and candidate qualification assessment, with human oversight; candidate information is handled in accordance with applicable privacy laws. Candidates may contact the provided email to ask about AI use or request an accommodation or alternative assessment.

Requirements

• 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.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.

Nice To Haves

• 0–5 years of experience in clinical research, project management, or related life sciences settings.
• Experience supporting rare disease, gene therapy, or long-term follow-up research programs.
• Experience working with sponsors, CROs, and external vendors.
• Exposure to digital health, mobile applications, or technology-enabled clinical research solutions.
• Understanding of clinical drug development, including Phase I–III clinical trials, registries, and observational studies.
• Strong problem-solving, communication, and collaboration skills, with the ability to work effectively in a team-based environment.

Responsibilities

• Support clinical 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 user acceptance testing (UAT) and product launches.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level