Clinical Research Associate
Precision Medicine Group
full-time
Posted on:
Location Type: Remote
Location: Spain
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About the role
- Oversees all aspects of study site management to ensure patient safety is protected
- Provides guidance at the site and project level towards audit readiness standards
- Updates, tracks and maintains study specific trial management tools/systems
- Manages site start up procedures including feasibility and recruitment of potential investigators
- Assists the negotiation of study budgets and the execution of investigator contracts
- Verifies the process of obtaining informed consent has been adequately performed
- Independently conducts all forms of site visits
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs
- Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management
- Develops and maintains good working relationship with investigators and study staff
- Performs investigational product (IP) inventory and reconciliation
- Performs data review activities, including remote EDC CRF and patient profiles review
- Identifies and processes Serious Adverse Events according to the procedures defined by the study team
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings
- Travels as necessary according to project needs
- Performs other duties as assigned by management
Requirements
- University degree life science/pharmacy/other health related discipline or equivalent experience
- Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies
- Excellent communication and organizational skills
- Evidence of a client focused approach
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
- Ability to travel overnight (up to 60% travel on average)
- Fluency in English and for non-English speaking countries the local language of country where position based.
Benefits
- Paid time off
- Volunteer time off
- Robust medical offerings
- Non-vested 401k plus company match
- Paid parental leave
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
study site managementaudit readiness standardsstudy trial management toolssite start up proceduresinvestigator contractsinformed consentdata review activitiesSerious Adverse Events processinginvestigational product inventoryremote EDC CRF review
Soft Skills
communication skillsorganizational skillsclient focused approachrelationship buildingproactive communicationindependenceattention to detailproblem-solvingteam collaborationadaptability