Tech Stack Google Cloud Platform
About the role Contribute to study planning, feasibility, and protocol development Identify, evaluate, and activate clinical trial sites Support contract and budget coordination during site startup Serve as a primary point of contact for site staff throughout the study Conduct site qualification, initiation, interim monitoring, and close-out visits Ensure compliance with protocol, ICH-GCP, FDA, and applicable local and global regulations Verify informed consent and assent processes and patient protections, including pediatric populations Apply risk-based monitoring strategies and escalate issues when needed Perform source document verification, CRF and eCRF review, and query resolution Monitor study databases for accuracy, completeness, and data integrity Collaborate with data management and biostatistics teams to resolve discrepancies Work closely with Global Clinical Affairs colleagues, regulatory, and operations teams to support study deliverables Provide input into study documents and clinical operations planning Requirements Bachelor’s degree in a scientific or healthcare field or RN/BSN AND a minimum 5 years of clinical research experience including independent monitoring Proficiency with CTMS, EDC, and Microsoft Office Suite Strong organizational skills with the ability to adapt quickly and manage competing priorities Excellent communication and problem-solving skills Ability to collaborate effectively in a global, cross-functional environment Ability to travel up to 25 percent for site visits and team meetings Must possess U.S. work authorization Demonstrated ability to manage clinical sites across multiple phases of a study Experience in Type 1 Diabetes, infectious diseases, or newborn screening clinical studies Background in pediatric and adolescent research including assent, consent, and age-appropriate protections Prior experience supporting FDA or IVDR submissions Multilingual capabilities are a plus Medical, Dental, and Vision Insurance Options Life and Disability Insurance Paid Time-Off Parental Benefits Compassionate Care Leave 401k with Company Match Employee Stock Purchase Plan Copy Applicant Tracking System Keywords Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills clinical research independent monitoring risk-based monitoring source document verification CRF review eCRF review data integrity clinical trial site activation protocol development budget coordination
Soft skills organizational skills communication skills problem-solving skills collaboration adaptability ability to manage competing priorities global teamwork site staff interaction issue escalation input into study documents
Certifications Bachelor’s degree in scientific field Bachelor’s degree in healthcare field RN BSN