Clinical Research Associate II - FSP

The role

The CRA II is a seasoned professional responsible for monitoring and site management. This role involves study start-up, on-site monitoring of clinical research studies, and ongoing site management.

What you will do

• Oversee study site management to ensure patient safety and data quality.
• Provide guidance towards audit readiness standards.
• Update and maintain study specific trial management tools and status reports.
• Manage site start up procedures including feasibility, recruitment, and regulatory documents.
• Assist in negotiating study budgets and executing investigator contracts.
• Verify the informed consent process.
• Conduct site visits including pre-study, initiation, routine monitoring, and close-out visits.
• Prepare and submit accurate monitoring reports.
• Document activities via confirmation letters, follow-up letters, and trip reports.
• Perform investigational product inventory and reconciliation.

Required qualifications

• 4-year college degree or equivalent experience in a scientific or healthcare discipline.
• Two (2) years or more 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.
• Fluency in English and for non-English speaking countries the local language of country where position based.

Nice to have

• Graduate or postgraduate degree
• Lupus monitoring experience
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
• Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management.

Benefits

• Paid time off
• Volunteer time off
• Robust medical offerings
• Non-vested 401k plus company match
• Paid parental leave
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Paid time off for sick leave and vacation

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

About the company

Precision for Medicine is a precision medicine CRO. Their integrated offerings combine novel clinical trial designs, medical experts, and data analytics solutions.