Bilingual Assistant, CRA

This is a fully remote position, open to applicants in Canada.

📋 Description

• Conduct remote tasks related to assigned clinical research projects in collaboration with the CRA and study Clinical Lead.

• Aid in site readiness and the logistical aspects of the monitoring process.

• Assist in site management and remote monitoring activities in compliance with SOPs and regulatory requirements.

• Execute study and site management tasks as outlined in the task matrix.

• Complete and document training specific to the study and provide orientation/training on study-specific systems.

• Offer internal support for pre-study assessments and waivers.

• Tailor site ICFs with relevant site contact information as necessary.

• Conduct remote reviews of EMR/EHR checklists.

• Confirm document collection and RCR submission status; update site EDL and site-related information.

• Review materials intended for patients and their translations.

• Assist with vendor qualifications, system access, site staff training, IM attendance logistics, vendor trackers, and management of study/site supplies.

• Facilitate the collection, review, and updates of Essential Documents.

• Follow up on any missing vendor data such as ECGs, lab samples, and e-diaries.

• Contribute to ongoing remote evaluations of centralized monitoring tools.

• Support site payment procedures, system updates, reconciliations, and invoice follow-ups.

• Carry out trial reconciliation duties involving CRF/query status, deviations, SAEs, and safety reports.

• Verify the status of document collection and take action on any missing, incomplete, expired, or open documents.

• Perform additional assigned site management tasks and specific client FSP role profiles.

• Complete administrative responsibilities including expense reports and timesheets.

• Ensure timely coordination with site and internal functional teams.

⛳️ Requirements

• Bachelor's degree in a life science field or a related area, or Registered Nursing certification or equivalent relevant formal academic/vocational qualification.

• Prior experience that provides the necessary knowledge, skills, and abilities to perform the role, typically ranging from 0 to 2 years.

• Equivalency may include a combination of appropriate education, training, and/or directly related experience.

• Basic knowledge of medical/therapeutic areas and familiarity with medical terminology.

• Capability to acquire and maintain a working understanding of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication abilities.

• Exceptional interpersonal and customer service skills.

• Solid organizational and time management skills with a keen attention to detail.

• Demonstrated capacity to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability to changing situations.

• Ability to work both in a team environment and independently.

• Well-developed critical thinking, root cause analysis, and problem-solving capabilities.

• Proficient computer skills with a strong command of MS Office; ability to learn and utilize relevant software.

• Ability to extract relevant information from study documents, electronic study data systems, CTMS, and dashboards.

• Excellent command of English and French language and grammar.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Opportunity to collaborate with a global team.

• Potential for promotional opportunities within the CRA career path.