Clinical Research Associate; Oncology Monitoring Experience Required
Abarca HealthSalary not specified
Full Time
Mid-level (3 to 4 years)
Sr CRA (Level I) - FSP Canada (ON or QC) - Oncology at Thermo Fisher Scientific
Montreal, Quebec, Canada
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, Pharmaceuticals, BiotechnologyIndustries
Requirements
- Ability to perform and coordinate all aspects of clinical monitoring and site management, including remote or on-site visits to assess protocol and regulatory compliance
- Knowledge of procedures and guidelines from different sponsors and monitoring environments (e.g., FSO, FSP, Government)
- Expertise in ICH-GCP guidelines, applicable regulations, and SOPs to ensure subject rights, well-being, and data reliability
- Skills in risk-based monitoring, including root cause analysis (RCA), critical thinking, and problem-solving to identify site process failures and implement corrective/preventive actions
- Capability to ensure data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review via on-site and remote activities
- Experience with investigational product accountability via physical inventory and records review
- Proficiency in documenting observations in reports and letters using approved business writing standards, and escalating deficiencies to clinical management
- Ability to maintain regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
- Familiarity with monitoring plans, investigator payment processes, and shared responsibility for issue resolution
- Willingness to travel overnight regionally or nationally as needed
- Experience with study systems like Clinical Trial Management System (CTMS) and performing QC checks on reports
- Ability to participate in investigator meetings and identify potential investigators in collaboration with clients
- Knowledge of clinical trial site initiation procedures for protocol and regulatory/ICH GCP compliance
Responsibilities
- Monitors investigator sites using a risk-based approach, applying RCA, critical thinking, and problem-solving to address site process failures and reduce risks
- Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
- Assesses investigational product via physical inventory and records review
- Documents observations in reports and letters timely using approved standards; escalates deficiencies and follows issues to resolution
- Maintains regular contact with sites between visits to verify protocol compliance, issue resolution, and timely data entry
- Conducts monitoring tasks per the approved monitoring plan
- Participates in the investigator payment process
- Shares responsibility with project team for issues/findings resolution and investigates/follows up on findings
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM)
- Updates study systems (e.g., CTMS) per agreed conventions and performs QC checks on CTMS reports
- Participates in investigator meetings as necessary
- Identifies potential investigators with the client to ensure qualified sites
- Initiates clinical trial sites according to relevant procedures for protocol, regulatory, and ICH GCP compliance
- Acts as a site processes specialist, ensuring audit readiness and developing collaborative relationships with sites
- Manages required documentation and ensures the trial is conducted per approved protocol, ICH-GCP, regulations, and SOPs
Skills
Clinical Monitoring
Site Management
ICH-GCP
Protocol Compliance
Regulatory Compliance
SOPs
Audit Readiness
Oncology
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees