Assistant CRA
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Job Description
Assistant Clinical Research Associate supporting monitoring and site management for clinical trials. Performing remote activities in collaboration with CRAs and Clinical Leads.
Responsibilities:
- Completes study and site management activities
- Completes and documents study-specific training
- Provides in-house support during pre-study assessments
- Supports to customize Site ICF with site contact details
- Performs remote review of EMR/EHR checklist
- Verifies document collection and updates site EDL
- Reviews patient-facing materials
- Supports site staff with vendor-related qualification process
- Provides support ensuring system access is granted/revoked
- Coordinates and supports logistics for IM attendance
- Maintains vendor trackers
- Supports Essential Document collection and review
- Follows up on missing study vendor data
- Supports ongoing remote review of centralized monitoring tools
- Assists with Site payments processes
- Performs reconciliation tasks on assigned trials
Requirements:
- Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent
- Previous experience (0 to 2 years)
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to maintain a working knowledge of ICH GCP and applicable regulations
- Effective oral and written communication skills
- Good organizational and time management skills
- Proficient computer skills with good knowledge of MS Office
Benefits:
- Reasonable accommodation for individuals with disabilities
- Opportunities for career development
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