Clinical Trial Nurse - Courtice, Ontario

CAN Canada; Canada; On-site; CAD 80,000 - 100,000; Part time

Job summary

A global clinical research leader is seeking candidates for a part-time clinical research support role to coordinate studies and ensure compliance with all regulations. Candidates should have relevant experience, strong communication skills, and be able to conduct complex procedures in clinical trials. This position focuses on patient recruitment and ensuring participant safety through thorough monitoring and documentation.

Qualifications

• Experience in clinical research and familiarity with FDA regulations.
• Strong communication and organizational skills.
• Ability to conduct complex clinical research procedures.

Responsibilities

• Coordinate and participate in clinical research studies.
• Schedule and execute study visits as delegated.
• Monitor subject safety and report adverse events.

Skills

Clinical research support

Patient recruitment

Regulatory compliance

Good Clinical Practice (GCP)

Data quality checking

Education

Bachelor's degree in a related field

Job description

Overview

Job Overview: Part time - 24 hours/wk and onsite support. Coordinate and participate in clinical research studies ensuring that studies are carried out according to protocol, contracted scope of work, good clinical practice, sponsor standard operating procedures (SOPs) and any relevant local guidelines and regulations.

Responsibilities

• Provides clinical research support to investigators to prepare for and execute assigned research studies
• Reviews study protocols, source document forms, other study-specific documents, and electronic data capture systems used to record clinical research data
• Collects and submits regulatory/ethics documentation as required by the Federal Drug Administration (FDA) and other regulatory bodies governing the conduct of the study
• Recruits and screens patients for clinical trials and maintain subject screening and enrollment logs
• Orients research subjects to the study including the purpose of the study, procedures and protocol requirements such as timeline for visits
• Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles
• Schedules and executes study visits and perform study procedures as delegated and supervised by the Principal Investigator
• Handles lab testing and analysis including preparation of specimen collection tubes and lab logistics
• Monitors subject safety and report adverse events and reactions to Principal Investigator, study team members and IRBs as appropriate
• Corresponds with research subjects to troubleshoot study-related questions or concerns
• Participates in routine meetings with site study staff and Investigators to confirm study tasks are assigned and executed to the expected standards
• Actively involved in study data quality checking and query resolution
• Performs a variety of complex clinical research procedures including but not limited to electrocardiogram (ECG), lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and questionnaire administration
• Updates and maintains site staff skills, training and knowledge of current best nursing practices and topics related to clinical research
• Assists the investigators to safeguard the well-being of subjects and maintain standards required of clinical research sites
• Maintains a safe environment in accordance with site policies
• Acts as an advocate for research subjects
• Addresses subject questions in a pro-active manner and take remedial action as required
• Assists and advise site staff in nursing practices and on the delivery of study care to subjects
• Reports any deviations from normal research practices to senior staff and implement agreed changes in the study care program
• Assists investigator in verifying that research study objectives are met on time, within budget and according to application protocol requirements, clinical research regulations and quality standards
• Assists in providing training to new investigator site staff members on study-specific topics and requirements
• Maintains adherence to investigator site staff training requirements by auditing and maintaining training records
• Provides guidance and supervision to lower level site staff to help ensure processes are carried out in line with protocols and SOPs, where applicable
• Participates in study process reviews and enhancement efforts to support control of site unit budget, development of the research facilities and site services and the culture towards a high performing research study team
• Prepares for and attends study monitoring visits, study audits and regulatory inspections with clinical research regulatory agencies
• Adheres to standard operating procedures (SOPs) and other directives throughout this process
• Assists research site with coverage planning related to staffing and scheduling for research projects

#LI-CES and #LI-DNP #LI-HCP #ONSITE

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez https://jobs.iqvia.com

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au [e-mail], afin qu’IQVIA puisse soutenir votre participation au processus de recrutement.

Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: [e-mail], so that IQVIA can support your participation in the recruitment process.

Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.