Clinical Research Associate

PLEASE NOTE: This role is only open to candidates currently based on the West Coast. Applications from candidates located outside of the West Coast will not be considered.

A growing clinical development organization is seeking a Clinical Research Associat e to support the delivery of complex clinical trials across multiple therapeutic areas. This is a remote-based role, but candidates must be based on the West Coas t and able to travel regularly to investigative sites

.The CRA will be responsible for ensuring assigned clinical trials are conducted in accordance with the study protocol, ICH-GCP, applicable regulatory requirements, and internal quality standards. This role will play a key part in protecting subject safety, maintaining data integrity, and supporting successful site performance

.
Key Responsibiliti

• esConduct site monitoring visits, including SSVs, SIVs, interim monitoring visits, and close-out visit
• s.Act as the main point of contact for assigned sites, ensuring strong communication and timely issue resolutio
• n.Monitor site compliance with the protocol, ICH-GCP, regulatory requirements, and study-specific procedure
• s.Perform SDV/SDR activities and support data quality, query resolution, and timely eCRF completio
• n.Identify, document, and escalate protocol deviations, risks, and quality concern
• s.Maintain accurate and inspection-ready site documentation in CTMS, eTMF, EDC, and other study system
• s.Support patient recruitment, retention, and site performance activitie
• s.Prepare monitoring visit reports, follow-up letters, and action plans within required timeline
• s.Collaborate with Project Managers, CTAs, start-up teams, and other cross-functional stakeholder

s.
Requireme

• ntsBachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related discipli
• ne.Prior independent on-site monitoring experience within a CRO, Pharma, or Biotech environme
• nt.5 years of clinical research or relevant clinical experien
• ce.Strong understanding of ICH-GCP, clinical trial regulations, and site monitoring expectatio
• ns.Experience supporting multiple investigative sites and clinical trial phas
• es.Experience with CTMS, EDC, and eTMF syste
• ms.Strong organizational, communication, and problem-solving skil
• ls.Ability to work independently in a remote environment with a secure home office set
• up.Willingness to travel regularly, up to approximately 60–80% depending on study nee
• ds.Must hold a valid driver’s licen
• se.Must be based on the West Coa

st.
Preferred Experi

• enceExperience in oncology, rare disease, complex, or early-phase clinical tri
• als.Pediatric or NICU experience would be highly prefer
• red.Nursing background is id
• eal.Exposure to risk-based monitoring and central monitoring to
• ols.Audit or inspection support experie
• nce.Additional language fluency is a p

lus.