Clinical Trial Nurse - Courtice, Ontario at IQVIA

Toronto, Ontario, Canada

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Part TimeJob Type

UnknownVisa

Healthcare, Clinical ResearchIndustries

Requirements

Knowledge of study protocols, source document forms, electronic data capture systems, Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles, sponsor SOPs, and relevant local guidelines/regulations
Ability to perform complex clinical research procedures including ECG, lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and questionnaire administration
Skills in lab testing and analysis, including preparation of specimen collection tubes and lab logistics
Up-to-date knowledge of current best nursing practices and topics related to clinical research
Adherence to site policies, SOPs, FDA requirements, and other regulatory bodies

Responsibilities

Provide clinical research support to investigators to prepare for and execute assigned research studies
Review study protocols, source document forms, other study-specific documents, and electronic data capture systems
Collect and submit regulatory/ethics documentation as required by FDA and other regulatory bodies
Recruit and screen patients for clinical trials and maintain subject screening and enrollment logs
Orient research subjects to the study, including purpose, procedures, and protocol requirements
Maintain source documentation based on protocol requirements adhering to GCP/ICH principles
Schedule and execute study visits and perform study procedures as delegated and supervised by the Principal Investigator
Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics
Monitor subject safety and report adverse events/reactions to Principal Investigator, study team, and IRBs
Correspond with research subjects to troubleshoot study-related questions or concerns
Participate in routine meetings with site study staff and Investigators to confirm study tasks are assigned and executed to standards
Actively involved in study data quality checking and query resolution
Update and maintain site staff skills, training, and knowledge of current best nursing practices and clinical research topics
Assist investigators in safeguarding subject well-being and maintaining clinical research site standards
Maintain a safe environment in accordance with site policies and act as an advocate for research subjects
Address subject questions proactively and take remedial action as required
Assist and advise site staff in nursing practices and delivery of study care to subjects
Report deviations from normal research practices to senior staff and implement agreed changes
Assist investigator in verifying that study objectives are met on time, within budget, and according to protocol, regulations, and quality standards
Assist in providing training to new investigator site staff on study-specific topics and requirements
Maintain adherence to investigator site staff training requirements by auditing and maintaining training records
Provide guidance and supervision to lower level site staff to ensure processes align with protocols and SOPs
Participate in study process reviews and enhancement efforts to support budget control, facility development, and high-performing team culture
Prepare for and attend study monitoring visits, audits, and regulatory inspections
Adhere to standard operating procedures (SOPs) and other directives
Assist research site with coverage planning related to staffing and scheduling for research projects

Skills

GCP

ICH

ECG

Patient Recruitment

Patient Screening

Adverse Event Reporting

Electronic Data Capture

Source Documentation

Lab Specimen Handling

Clinical Trial Coordination

Regulatory Documentation

IRB Reporting

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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