Clinical Research Associate II - FSP
New
P
Precision for MedicineClinical research
Location: Remote, United StatesFull-TimeMiddle
Salary$91,500 — $137,300 USD
Apply NowOpens the employer's application page
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
- EHR
Requirements
- 4-year college degree or equivalent experience in a scientific or healthcare discipline.
- At least two years as a CRA in a CRO, or equivalent relevant experience and/or demonstrated competencies.
- Site management or equivalent experience in clinical research.
- Excellent communication and organizational skills.
- Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
- Ability to travel overnight; up to 60% travel on average based on regional requirements, with international travel as needed.
- Fluency 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: Lupus monitoring experience or experience in rare and complex therapeutic areas.
- Preferred: experience monitoring EDC trials and EHR records.
Responsibilities
- Oversee study site management to protect patient safety and maintain data quality.
- Provide site- and project-level guidance on audit readiness and support audit preparation and follow-up.
- Maintain study trial management tools, systems, status reports, and required site documentation.
- Conduct site visits, including pre-study, qualification, initiation, routine monitoring, and close-out visits.
- Prepare timely monitoring reports and document site activities in accordance with SOPs and project requirements.
- Review Investigator Site Files and reconcile them with the Trial Master File.
- Review EDC case report forms and patient profiles, resolve queries, and support data discrepancy resolution.
- Review investigational product inventory, storage, dispensing, administration, and reconciliation.
- Identify and process Serious Adverse Events and escalate site risks with proposed contingencies.
- Communicate study issues with site personnel and project and clinical trial management teams.
View Full Description & ApplyYou'll be redirected to the employer's site
