Assistant CRA
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Job Description
Assistant Clinical Research Associate supporting clinical trials and managing logistics for study sites. Collaborating with clinical teams and ensuring compliance with regulatory guidelines while working remotely.
Responsibilities:
- Completes study and site management activities as defined in task matrix
- Completes and documents study-specific training
- Orients and trains on any study-specific systems
- Provides in-house support during pre-study assessments
- Supports to customize Site ICF with site contact details as needed
- Performs remote review of EMR/EHR checklist
- Verifies document collection and RCR submission status
- Reviews patient facing materials
- Supports site staff with the vendor related qualification process
- Provides support by ensuring system access is requested/granted and revoked
- Supports follow-up on site staff training
- Coordinates and supports logistics for IM attendance
- Supports maintenance of vendor trackers
- Coordinates study/site supply management
- Supports Essential Document collection, review and updating
- Follows up on missing study vendor data
- Supports ongoing remote review of centralized monitoring tools
- Supports Site payments processes
- Performs reconciliation tasks on assigned trials
- Verifies document collection status in company systems
- May perform other assigned site management tasks
- Maintains & completes administrative tasks such as expense reports and timesheets
Requirements:
- Bachelor's degree in a life science discipline or related field or a Registered Nursing certification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
- Effective oral and written communication skills
- Excellent interpersonal and customer service skills
- Good organizational and time management skills and strong attention to detail
- Proven flexibility and adaptability
- Ability to work in a team or independently as required
- Well-developed critical thinking skills
- Proficient computer skills with good knowledge of MS Office
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
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