Assistant CRA - Toronto, ON

Thermo Fisher Scientific

About The Position

The Assistant Clinical Research Associate supports assigned clinical research projects by performing remote activities in liaison with the CRA and study Clinical Lead. The role provides site preparedness and logistical support to monitoring, and assists with site management and remote monitoring in accordance with SOPs and regulatory guidelines. Limited site contact activities may be assigned during study start-up, site management, recruitment, and close-out phases. The position carries out study and site management tasks as directed in the task matrix, supports study training and systems, contributes to essential document and vendor-data management, and assists with site payments, supplies, and monitoring-related reconciliations. Work is performed primarily in an office or home-office environment, with occasional travel to clinics or hospitals. The role does not involve regular travel; direct promotional opportunities in the CRA career track require frequent travel of 60–80%. The estimated annualized pay range in Ontario is $66,800–$85,000.

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 equivalent combination of appropriate education, training, and/or directly related experience may be considered.
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 the 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 language and grammar skills.

Responsibilities

Complete study and site management activities as defined in the task matrix and as directed for assigned studies.
Complete and document study-specific training and learn study-specific systems.
Provide in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for the project.
Support customization of site informed consent forms with site contact details, as needed.
Perform remote review of EMR/EHR checklists and support applicable assessments and collection activities.
Verify document collection and RCR submission status; update the site EDL and verify site information.
Review patient-facing materials and translations, as directed.
Support site staff with vendor qualification processes, where applicable.
Help ensure system access is requested, granted, and revoked for relevant site staff during pre-activation and throughout the study.
Follow up on site staff training, as applicable.
Coordinate and support logistics for IM attendance, as directed.
Support maintenance of vendor trackers, as directed.
Coordinate study and site supply management during pre-activation and throughout the study.
Support collection, review, and updating of essential documents in systems, as applicable.
Follow up on missing study vendor data, such as 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 organizational functional departments and the site; support system updates and reconciliations and follow up on site invoices throughout the study.
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 drive action on missing, incomplete, or expired documents and open document findings, as directed.
Perform other assigned site management tasks as directed by the CRA and according to the task matrix; may perform a specific role profile for FSP opportunities according to client requests.
Complete administrative tasks, including expense reports and timesheets, in a timely manner.