Associate, Clinical Operations

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Provide support for studies from initiation through to closeout.

• Oversee relationships with sponsors, sites, and vendors.

• Engage in discussions regarding protocol design and implementation planning.

• Create IRB submission packages, training materials, caregiver/site manuals, and operational documentation.

• Lead or assist in Site Initiation Visits (SIVs), site training, and central rater training activities.

• Collaborate with Data Management, Product Management, and Technical Delivery teams.

• Assist with User Acceptance Testing (UAT) and product launches.

⛳️ Requirements

• Bachelor’s degree or equivalent professional experience is required.

• 1–10 years of relevant experience is necessary.

• Proven experience in operationalizing clinical study protocols, amendments, observational research studies, and registries.

• Professional background in biotech, pharmaceuticals, CRO, clinical sites, or consulting environments.

• Familiarity with GCP, ICH, HIPAA, GDPR, FDA regulations, and clinical research guidelines.

• Experience in managing multiple research projects, vendors, sponsors, sites, and stakeholders concurrently.

• Practical knowledge of EDC, ePRO, EHR, and clinical research technologies.

• Excellent written and verbal communication abilities.

• Proficient in Microsoft Office applications (Word, Excel, PowerPoint).

• Experience in digital health or mobile applications is preferred.

• Background in rare diseases, gene therapy, or long-term follow-up studies is advantageous.

• Understanding of clinical drug development pathways, including Phase I–III studies and registries is preferred.

🏝️ Benefits

• Equal opportunity employment.

• An inclusive workplace culture.

• Commitment to diversity, equity, and inclusion.

• No discrimination based on race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.