Clinical Trial Jobs in Canada.
All active Clinical Trial roles based in Canada.
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Senior Medical Writer
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Position Summary:
The Senior Medical Writer (MW) will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.
Essential functions of the job include but are not limited to:
- Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidances
- Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments
- Ability to independently formulate key messages from clinical study data
- Ability to author complex content using knowledge/skills and understanding of processes
- Ability to communicate clearly and concisely both in writing and verbally with internal and client teams
- Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
- Excellent problem-solving skills
- Performing literature-based research to support writing activities
- Other duties as assigned
Qualifications:
Minimum Required:
- BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
- 5+ years of experience as a medical writer in the sponsor and/or CRO setting
Other Required:
- Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
- Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for all phases of development
- Impeccable attention to detail and ability to complete writing assignments in a timely manner
- Ability to work effectively in a fast-paced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments
Preferred:
- Advanced degree (MS/PhD)
- Oncology and/or rare disease experience (especially protocol and CSR development)
Precision is required by law in some states, cities and or countries to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Salary Range: $101,800 - 152,600
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Medical Writer
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Position Summary:
The Senior Medical Writer (MW) will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.
Essential functions of the job include but are not limited to:
- Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidances
- Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments
- Ability to independently formulate key messages from clinical study data
- Ability to author complex content using knowledge/skills and understanding of processes
- Ability to communicate clearly and concisely both in writing and verbally with internal and client teams
- Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
- Excellent problem-solving skills
- Performing literature-based research to support writing activities
- Other duties as assigned
Qualifications:
Minimum Required:
- BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
- 5+ years of experience as a medical writer in the sponsor and/or CRO setting
Other Required:
- Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
- Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for all phases of development
- Impeccable attention to detail and ability to complete writing assignments in a timely manner
- Ability to work effectively in a fast-paced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments
Preferred:
- Advanced degree (MS/PhD)
- Oncology and/or rare disease experience (especially protocol and CSR development)
Precision is required by law in some states, cities and or countries to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Salary Range: $101,800 - 152,600
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Clinical Research Coordinator, RN
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Clinical Research Coordinator, RN conducts delegated clinical tasks and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.
How You'll Make An Impact
- Ability to understand and follow institutional SOPs.
- Review and assess protocol (including amendments) for clarity, logistical feasibility
- Ensure that all training and study requirements are met prior to trial conduct.
- Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
- Assist with planning and creation of appropriate recruitment materials.
- Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
- Actively work with recruitment team in calling and recruiting subjects
- Attend Investigator meetings as required.
- Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
- Assist in the creation and review of source documents.
- Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
- Study Management:
- Prioritize activities with specific regard to protocol timelines
- Maintain adherence to Health Canada Division 5 regulations and ICH guidelines in all aspects of conducting clinical trials.
- Maintain effective relationships with study participants and other care Access Research personnel.
- Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
- Communicate clearly verbally and in writing.
- Patient Coordination:
- Prescreen study candidates
- Obtain informed consent per Care Access Research SOP .
- Complete visit procedures in accordance with protocol.
- Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
- Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
- Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
- Documentation:
- Record data legibly and enter in real time on paper or e-source documents
- Accurately record study medication inventory, medication dispensation, and patient compliance.
- Resolve data management queries and correct source data within sponsor provided timelines
- Assist regulatory personnel with completion and filing of regulatory documents.
- RN specific duties:
- Preparation and administration of Investigational Product (IP; study drug)
- Monitor participant for adverse reactions
- Communicate regularly with PI.
- Maintain a clean work area.
- Comply with Safety and PPE standards.
- Perform phlebotomy and insert IV catheters.
- Conduct delegated clinical procedures as required per protocol.
- Comply with regulatory requirements, policies, procedures, & standards of practice.
- Receipt and proper storage of investigational products
- Maintain Investigational Product records in accordance with regulations and sponsor requirements.
- Maintain the blinding of all study products where required.
- Maintain proper storage, security and temperature for all medications and investigational products.
- Maintain appropriate research training and RN licensure in good standing in the province of Clinical Trials activities
The Expertise Required
- Working knowledge of medical and research terminology
- Working knowledge of federal regulations, good clinical practices (GCP)
- Excellent phlebotomy skills
- Ability to communicate and work effectively with a diverse team of professionals.
- Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
- Ability to work independently in a fast-paced environment with minimal supervision.
- Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments.
- Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.
- Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
- Strong computer skills
- Ability to balance tasks with competing priorities.
- Critical thinker and problem solver.
- Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.
- Friendly, outgoing personality; maintain a positive attitude under pressure.
- High level of self-motivation and energy.
- Ability to work independently in a fast-paced environment with minimal supervision.
- Must have a client service mentality.
- A minimum of 1 year of relevant work experience required.
- RN license in good standing required.
- Phlebotomy and infusion experience required.
- Clinical Research Experience preferred.
How We Work Together
- Location: Cape Breton, Canada
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Benefits
- 6 weeks paid vacation annually
- Access to group health benefits plan for self and dependents
- Voluntary group RRSP retirement plan with matched contributions
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access