Assistant CRA
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Job Description
Assistant Clinical Research Associate supporting site management and remote monitoring for pharmaceutical and biotech clinical trials. Coordinating documents, vendors, payments, training, and study systems.
Responsibilities:
- Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
- Support site preparedness and provide logistical support to the monitoring process
- Assist with site management and remote monitoring tasks in accordance with SOPs and regulatory guidelines
- Complete study and site management activities defined in the task matrix
- Complete study-specific training and orient/train on study-specific systems
- Provide in-house support during pre-study assessments and assessment waivers
- Customize Site ICFs with site contact details as needed
- Perform remote review of EMR/EHR checklists and support assessment collection
- Verify document collection and RCR submission status; update site EDL and verify site information
- Review patient-facing materials and translations
- Support vendor qualification processes and site staff system access
- Follow up on site staff training
- Coordinate logistics for IM attendance and maintain vendor trackers
- Coordinate study/site supply management
- Support Essential Document collection, review and updating in systems
- Follow up on missing vendor data including ECGs, lab samples and e-diaries
- Support ongoing remote review of centralized monitoring tools
- Support site payment processes, system updates, reconciliations and invoice follow-up
- Perform reconciliation tasks including CRF and query status, deviations, SAEs and safety reports
- Verify document collection status and drive action for missing, incomplete or expired documents
- Perform other assigned site management tasks and client-requested FSP role profiles
- Complete administrative tasks including expense reports and timesheets
Requirements:
- Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Equivalency combining appropriate education, training and/or directly related experience may be considered
- Previous experience comparable to 0 to 2 years
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain 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 ability to handle multiple tasks efficiently and effectively
- Flexibility and adaptability
- Ability to work in a team or independently
- Well-developed critical thinking, root cause analysis and problem-solving skills
- Proficient computer skills and good knowledge of MS Office; ability to learn and use appropriate software
- Ability to extract pertinent information from study documents, electronic study data systems, CTMS and dashboards
- Excellent English language and grammar skills
Benefits:
- Fully remote work arrangement
- Standard Office Hours (40/wk)
- Opportunity for promotion to CRA within 1–2 years
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