Bilingual Assistant, CRA
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Job Description
Assistant CRA supporting remote clinical trial site management for pharmaceutical and biotech companies. Coordinating documents, monitoring logistics, vendor data, payments, and compliance activities.
Responsibilities:
- Perform remote activities on assigned clinical research projects in liaison with the CRA and study Clinical Lead
- Support site preparedness and the logistics of 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 for pre-study assessments and waivers
- Customize site ICFs with site contact details as needed
- Perform remote EMR/EHR checklist reviews
- Verify document collection and RCR submission status; update site EDL and site information
- Review patient-facing materials and translations
- Support vendor qualification, system access, site staff training, IM attendance logistics, vendor trackers, and study/site supply management
- Support Essential Document collection, review, and system updates
- 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 trial reconciliation tasks involving CRF/query status, deviations, SAEs, and safety reports
- Verify document collection status and drive action on missing, incomplete, expired, or open documents
- Perform other assigned site management tasks and client-specific FSP role profiles
- Complete administrative tasks such as expense reports and timesheets
- Maintain timely coordination with site and internal functional teams
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 providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 2 years
- Equivalency may consist of a combination of appropriate education, training, and/or directly related experience
- 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 and French language and grammar skills
Benefits:
- Fully remote work arrangement
- Standard Monday–Friday work schedule
- Opportunity to work with a global team
- Potential promotional opportunities in the CRA career track
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