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Clinical Research Associate - Ontario

• Location: Canada, Toronto
• Categories Clinical Monitoring
• __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions

TA Business Partner

• Icon Strategic Solutions

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About the role.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and  we welcome you to join us on our mission to shape the future of clinical development as a Clinical Research Associate II. 

What you will be doing:

• Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
• Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
• Proactive site management including:
• Building and maintaining solid and professional relationships with site staff
• Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
• Maintaining site audit/inspection readiness
• Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks
• Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
• Responding to site queries and escalating issues in accordance with processes and timelines
• Conducting IP accountability and reconciliation
• Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
• Maintenance of site study supplies

 O perational Excellence:

• Contribute to sponsor goals
• Promote operational and scientific excellence
• Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.
• BA/BS/BSc in the sciences or nursing equivalent
• A trained CRA with on-site monitoring experience
• Comprehensive knowledge and understanding of ICH-GCP
• Fluent oral (face to face and telephone) and written English language skills
• Able and willing to travel up to 60% of the time or as per local requirements
• Possession of a full driver’s license
• Able and willing to work from a designated and appropriate home office as per local requirements
• Willing to attend and contribute to team meetings including mandatory training (remote/off-site)
• Competent computer skills including working knowledge of common software packages
• Working knowledge of trial management databases and on-line systems
• Able to attend a 1 week face to face in-house training course as part of on-boarding training
• Able and willing to work on several protocols/therapy areas
• Experience in phase II and phase III trials (preferred)
• Working knowledge of Electronic Data Capture (preferred)

  Experience/working knowledge of the oncology disease area (preferred)

• Experience of Centralized/Risk Based/Targeted monitoring (preferred)
• Experience of working within a metric based environment (preferred)

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce

 Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.

Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?

Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.

Suzaita Hipolito

Press play to find out more

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• Patient Recruitment & Clinical Research Associate

We are seeking a motivated and enthusiastic Patient Recruitment & Clinical Research Associate with prior experience in diabetic foot ulcer (DFU) studies. In this exciting and highly visible position at Piomic Medical, you will play a vital project management role in our US clinical trials, beginning with our current Phase III Investigational Device Exemption (IDE) DFU clinical study.

This position offers a rewarding opportunity to work in a fast-paced startup environment for a multinational medical device company, headquartered in Zurich, Switzerland with a U.S. subsidiary in the Chicago metro area. You will engage in a variety of clinical trial activities that foster professional development and personal fulfillment, while advancing the Company’s leadership position as an innovator in the wound healing space. The company’s core technology platform, COMS™ One therapy, received CE Mark Approval in 2020 and is currently treating patients with lower extremity ulcers in Europe.

Patient Recruitment Responsibilities

• Work closely with clinical team members to develop and fulfill patient recruitment and retention strategies for assigned protocols.
• Propose new patient recruitment strategies, including those that can be performed by Company personnel, independent of established patient recruitment vendors.
• Develop a patient identification strategy, journey map and experience plan that collectively increase patient recruitment and retention.
• Manage workflow and internal review of patient facing materials between internal and external stakeholders.
• Monitor success of recruitment programs using agreed upon metrics/KPIs, prepare data-based reports, and make recommendations for improvements.
• Contact physician referral sources to generate study awareness and request patient referrals.
• Collect and relay enrollment and retention best practices to all study sites and other stakeholders.
• Contribute to vetting and recommending patient recruitment vendors and related third parties.
• Complete other tasks as assigned by supervisor.

Clinical Research (CRA) Responsibilities

• Collaborate in the development and execution of clinical strategies to support US trials.
• Support all stages of clinical studies, overseeing study startup activities and maintaining involvement throughout the trial and during closeout activities.
• Support the negotiation of contracts and budgets.
• Provide training to study staff on protocol, device handling, proper data collection, and safety event reporting.
• Perform an ongoing review and reconciliation of the data collected by the research sites.
• Participate and occasionally lead regularly scheduled update calls with study sites.
• Participate in weekly study progress meetings with CRO and Company personnel.
• Support investigational product controls, inventory tracking, and investigational device shipment and return procedures.
• Collaborate with internal staff and CRO to create necessary study materials, including worksheets, CRFs, study logs, reports, and tracking tools.

Requirements

Education Requirements and Qualifications

• Bachelor's degree preferred, associate’s degree a minimum
• Minimum 3 years’ experience working within patient recruitment/retention and clinical trials
• Diabetic foot ulcer trial experience required
• Proven results generating successful patient recruitment strategies in a clinical research department or for a patient recruitment organization
• Experience supporting research staff at clinical study sites/hospitals
• Medical device experience preferred
• Good understanding of Good Clinical Practice guidelines
• Excellent oral, written and interpersonal communication skills
• Strong customer focus, presentation, and project management skills
• Strong sense of urgency to meet timelines and project deliverables
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while remaining flexible to changing conditions
• Global reporting experience preferred
• Willing to travel up to 50%
• Part-time candidates will be considered (minimum 20 hours/week)

We offer a competitive salary and benefits package, plus a dynamic and collaborative work environment.

We welcome you to apply for this exciting opportunity at Piomic Medical. Your contributions will have a direct and meaningful impact on the success of our first U.S. clinical trial, and in turn, on our entry into the U.S. advanced wound care market.

Applications will be reviewed in a timely manner. Candidates selected for interviews will be contacted for scheduling, and all candidates will be notified of their application status. We hope to fill this position within 4-6 weeks. Thank you for considering Piomic Medical for your next role.

Piomic Medical AG

There are about 50 million reported cases of patients suffering from hard-to-heal wounds, which has created a severe cost burden on global healthcare systems.

Piomic develops an…

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• Jobs at Piomic Medical AG

Clinical Research Budget and Coverage Analyst

Job description.

Work Status Details: REGULAR FULL TIME | 80.00 Hours Every Two Weeks Pay Rate Type: Annual Salary Location: Remote

Listed is the base hiring salary range offered for this position. Actual salaries may vary depending on factors, including but not limited to skills and experience. The salary range listed is just one component of the total rewards/compensation package offered to candidates. Min = $91,359.840 Mid = $118,767.792

The role of the Clinical Research Budget and Coverage Analyst is to review clinical trial documents to determine if the study is a qualifying clinical trial pursuant to the Center for Medicare and Medicaid Services (CMS) policy, create/negotiate research budgets and generate a coverage analysis and billing plan according to payor rules, and then build an internal cost-based budget. 

Responsibilities:

1. Reviews clinical trial documents to determine if the study is a qualifying clinical trial pursuant to the CMS National Coverage Determination (NCD) 310.1, also known as the Medicare Clinical Trial Policy, or otherwise approved by CMS.

2. Reviews clinical trial documents to determine study type and identifies all protocol required items and services.

3. Conducts and documents a coverage analysis and internal budget on all clinical research projects regardless of funding source (e.g., industry, government, or other identified funding source, or in the absence of an identified funding source).

• Determines clinical trial qualification.
• Determines appropriate payor source for clinical trial items and services incorporating appropriate Medicare coverage rules to ensure all charges associated with the research activities are billed to the appropriate parties.
• Using the coverage analysis, develops a complete internal cost-based budget for all items and services that cannot be billed to insurance and therefore need to be paid by a sponsor or other funding source to ensure costs associated with research activities are fully recovered.
• Coordinates as needed with appropriate ancillary departments regarding pricing.
• Provides identified study funding gaps to the Institutional Research Director in a timely manner.
• Updates budget and coverage analysis whenever there is a protocol or contract/budget amendment.

4. Provides coverage analysis to clinical research financial analyst to ensure proper payment from Sponsors, patients and/or third parties.

5. Provides guidance to clinical research regulatory coordinator regarding informed consent form (ICF) financial language.

6. Supports institutional development and implementation of research billing related policies, procedures and standard operating procedures (SOP), and subsequent standards for training.

7. Maintains current knowledge of applicable research related Medicare and Medicaid reimbursement guidelines, and payor requirements and apprise institutional organizational as indicated.

8. Maintains current knowledge of research coding regulations as they relate to Medicare Clinical Trial Policy and conduct training for the clinical research team as indicated.

9. Serves as an expert resource to clinical research team as it relates to Medicare and Medicaid policies and coverage.

10. Participates in continuing education to keep updated on new rules, regulations and revisions, as set forth by the Center for Medicare and Medicaid Services (CMS) and other entities regarding billing compliance.

11. Maintains professional growth through participation in continuing education programs.

12. Other duties as indicated.

Minimum Requirements:

· Bachelor’s degree or higher in clinical health sciences preferred, such as Doctor of Pharmacy (Pharm.D) or nursing degree from an accredited four-year nursing school.

· Three  years of recent work experience (or equivalent education) in clinical research or related fields, preferably in billing, coverage determinations and budgeting and/or understanding of research billing regulations.

· One year experience in basic accounting or finance functions preferred.

· Certification in SOCRA or ACRP (Certification should be achieved within 3 years in role)

Why Yuma Regional Medical Center?

Yuma Regional Medical Center (YRMC) is located in Yuma, AZ. Our purpose is building a healthier tomorrow. We strive by putting patients first as they are the center of every decision and action we take. YRMC is rooted in the community by living and breathing the dynamic nature of our region. Being committed to progress by constantly and consistently advancing healthcare, creating meaningful experiences and improving the lives of everyone around us.

Bring Kindness | Achieve Together | Aspire For Better | Do The Right Thing | Lead With Optimism |

About Yuma, AZ

Named by the Guinness World Records as the Sunniest City on Earth with winters averaging temperatures of 70 degrees, sunny days and cooler nights.

Yuma, Arizona is a place to explore the great outdoors with hiking, jet skiing, boating and off-roading. Don’t forget to soak up the sun at the great Colorado River or one of Yuma’s many lakes.

Yuma is centrally located in Southwest Arizona, within a short drive to many popular attractions and destinations.

https://www.visityuma.com/

https://www.yumachamber.org/

Bring your skills to one of the sunniest places on earth - Yuma, AZ!

Physical Requirements and working conditions for this position will be provided to you up on interview. 

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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Posted : 7/1/2024

Job Status : Full Time

Job Reference # : 8542

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