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 Associate 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 Coast 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