Clinical Research Associate II - FSP

New

Location: Remote, United StatesFull-TimeMiddle

Salary$91,500 — $137,300 USD

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Job Details

Languages: Fluency in English and for non-English speaking countries the local language of country where position based
Experience: Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies.
Required Skills: Microsoft Office

Hold a four-year college degree or have equivalent experience in a scientific or healthcare discipline.
Have at least two years of CRA experience in a CRO, or equivalent relevant experience and demonstrated competencies.
Have site management or equivalent clinical research experience.
Demonstrate excellent communication and organizational skills and a team-oriented approach.
Demonstrate a client-focused approach.
Have experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
Be able to travel overnight; travel averages up to 60% based on regional requirements, with international travel as needed.
Be fluent in English and, for non-English-speaking countries, the local language of the country where the position is based.
Preferred: graduate or postgraduate degree.
Preferred: monitoring experience in oncology, cardiology, or lupus; lupus monitoring experience is specifically preferred.
Preferred: experience in rare and complex therapeutic areas, EDC trials, EHR records, or biopharma.
Preferred: country-specific site start-up experience, including feasibility, contract negotiations, or submissions.

Oversee study site management to protect patient safety and maintain data quality.
Guide sites and project teams on audit readiness and support audit preparation and follow-up.
Maintain study-specific trial management tools, systems, and status reports.
Manage site start-up activities when required, including feasibility, investigator recruitment, regulatory submissions, and document collection and review.
Conduct pre-study, qualification, initiation, routine monitoring, and close-out visits in accordance with protocols, local laws, ICH-GCP, and company SOPs.
Prepare timely monitoring reports and document site activities, follow-up actions, and observations in project systems.
Review Investigator Site Files and reconcile them with the Trial Master File.
Review EDC data and patient profiles, resolve queries, and support resolution of data discrepancies.
Review investigational product inventory, storage, dispensing, administration, and reconciliation.
Identify and process serious adverse events, escalate site risks, and drive timely risk resolution.

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