Assistant CRA – FSP
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Job Description
Assistant Clinical Research Associate supporting remote site preparedness, monitoring, documentation, and payments. Contributing to clinical trials for pharmaceutical and biotech sponsors.
Responsibilities:
- Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
- Support site preparedness and 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 and document 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
- 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
- Maintain vendor trackers and coordinate study/site supplies
- Support essential document collection, review, and updating in systems
- Follow up on missing vendor data including ECGs, lab samples, and e-diaries
- Support remote review of centralized monitoring tools
- Support site payment processes, system updates, reconciliations, and invoice follow-up
- Perform reconciliation tasks involving CRF and query status, deviations, SAEs, and safety reports
- Verify document collection status and drive action on missing, incomplete, or expired documents
- Perform other assigned site management tasks and client-requested FSP role activities
- Complete administrative tasks such as 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
- Previous experience comparable to 0 to 2 years
- Equivalency through a combination of appropriate education, training, and/or directly related experience may be accepted
- 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
- Ability to handle multiple tasks efficiently and effectively
- Flexibility and adaptability
- Ability to work independently or in a team
- 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 and modern technology
- 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 Monday–Friday work schedule
- Occasional travel to clinics/hospitals may be required
- Potential promotional opportunities in the CRA career track
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