Bilingual Assistant CRA - Montreal, QC

Thermo Fisher Scientific

19h

About The Position

The Assistant Clinical Research Associate provides remote support for assigned clinical research projects, working with the CRA and study Clinical Lead. The role supports site preparedness, logistics for monitoring, site management, and remote monitoring in accordance with standard operating procedures and regulatory guidelines. Limited site-contact activities may be assigned during study start-up, site management, recruitment, and close-out. Occasional travel to clinics or hospitals may be required; the role does not involve regular travel. The position also includes administrative responsibilities, such as completing expense reports and timesheets promptly. Other assigned site-management tasks or a client-specific role profile for an FSP opportunity may be included as directed.

Requirements

Bachelor’s degree in a life science discipline or related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0–2 years; an appropriate combination of education, training, and/or directly related experience may be considered equivalent.
Basic medical or 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, strong attention to detail, and proven ability to handle multiple tasks efficiently and effectively.
Flexibility and adaptability.
Ability to work in a team or independently as required.
Well-developed critical-thinking skills, including a critical mindset, in-depth investigation for root-cause analysis, and problem-solving.
Proficient computer skills and good knowledge of MS Office, with ability to learn and use appropriate software and leverage modern technology when applicable.
Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards.
Excellent English and French language and grammar skills.

Responsibilities

Complete study and site management activities defined in the task matrix and directed for assigned studies.
Complete and document study-specific training, and learn study-specific systems.
Provide in-house support for pre-study assessments and assessment waivers, as agreed for the project.
Help customize site informed consent forms with site contact details as needed.
Perform remote review of EMR/EHR checklists and support applicable assessment collection.
Verify document collection and RCR submission status, update site EDLs, and verify site information.
Review patient-facing materials and translations as directed.
Support site staff with vendor qualification processes where applicable.
Help request, grant, and revoke system access for relevant site staff before activation and during the study.
Follow up on site staff training as applicable.
Coordinate and support logistics for IM attendance as directed.
Maintain vendor trackers as directed.
Coordinate study and site supply management before activation and throughout the study.
Support collection, review, and updating of essential documents in systems as applicable.
Follow up on missing study vendor data, including ECGs, lab samples, and e-diaries, as directed.
Support ongoing remote review of centralized monitoring tools as directed.
Support site payment processes by coordinating with internal functional departments and sites; support system updates and reconciliations and follow up on site invoices.
Perform reconciliation tasks on assigned trials, including CRF and query status, deviations, SAEs, and safety reports as applicable.
Verify document collection status in company systems and take directed action on missing, incomplete, or expired documents and open document findings.
Perform other assigned site-management tasks as directed by the CRA and task matrix; may perform a client-requested role profile for FSP opportunities.
Complete administrative tasks, including expense reports and timesheets, in a timely manner.