Bilingual Clinical Research Associate, Experienced
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Canada
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Job Level
Tech Stack
About the role
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in investigator meetings as necessary.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Requirements
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship
- Valid driver's license where applicable.
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English and French language and grammar skills
- Good presentation skills
Benefits
- Health insurance
- Paid time off
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical monitoringroot cause analysisdata accuracySDRSDVCRF reviewrisk-based monitoringmedical terminologyICH GCPregulatory compliance
Soft Skills
critical thinkingproblem solvingcommunication skillsorganizational skillstime managementinterpersonal skillsattention to detailflexibilityadaptabilitycustomer focus
Certifications
Bachelor's degree in life sciencesRegistered Nursing certificationPPD Drug Development Fellowship