Clinical Research Associate

PLEASE NOTE: This role is only reputed company to candidates currently based on the reputed company Coast. Applications from candidates located reputed company of the reputed company Coast will not be considered. A growing clinical development organization is seeking a Clinical Research Associate to support the delivery of reputed company clinical trials across multiple therapeutic areas. This is a remote-based role, but candidates must be based on the reputed company Coast and reputed company 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 reputed company standards. This role will play a key part in protecting subject safety, maintaining data reputed company, and supporting successful site performance . Key Responsibiliti

• esConduct site monitoring reputed company, including SSVs, SIVs, interim monitoring reputed company, and reputed company-out visit
• s.reputed company as the main reputed company of contact for assigned sites, ensuring strong communication and reputed company issue resolutio
• n.Monitor site compliance with the protocol, ICH-GCP, regulatory requirements, and study-specific procedure
• s.reputed company SDV/SDR activities and support data reputed company, query reputed company, and reputed company eCRF completio
• n.Identify, document, and escalate protocol deviations, risks, and reputed company concern
• s.Maintain accurate and inspection-reputed company site documentation in CTMS, eTMF, reputed company, and other study system
• s.Support patient recruitment, retention, and site performance activitie
• s.Prepare monitoring visit reports, follow-up letters, and reputed company plans reputed company required reputed company
• 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 reputed company discipli
• ne.Prior independent on-site monitoring experience reputed company a CRO, reputed company, 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, reputed company, 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 reputed company’s licen
• se.Must be based on the reputed company Coa

st. Preferred Experi

• enceExperience in oncology, rare disease, reputed company, 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 reputed company is a p

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