About the Clinical Trial Agreements Office
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The Clinical Trial Agreements (CTA) Office is a large and expanding department situated within Research Legal and falls under the provision of both Corporate Legal and Research at UHN. The CTA Office helps to facilitate approximately 2,000 contracts a year for research involving human participants. Thousands of research studies are undertaken at UHN every year. While some involve UHN researchers and clinicians only, most involve third-parties such as pharmaceutical and medical device companies, government or funding agencies, contract research organizations and other research institutions. It is imperative that appropriate legal agreements are in place to govern these relationships as well as to manage and mitigate risk to the UHN and UHN research participants.
Position Summary
The Research Agreement Specialist is an essential part of preparing and negotiating legal agreements for UHN research studies.
Duties
- Drafting/reviewing, negotiating, and administering a high volume of clinical trial agreements, research contracts/subcontracts, material transfer agreements, data-sharing agreements, and agreements with collaborating institutions, research consortia, non-profit organizations, affiliated institutions, and other universities.
- Develop agreement strategies and also review and assess study submissions by researchers to determine study complexity and requirements.
- Engage with key internal stakeholders such as the Research Ethics Board, Research Financial Services and senior management for briefing and decision-making.
- From beginning to end, the Research Agreement Specialist must be able to manage institutional risk and provide effective and efficient service and support to researchers.
- The development of SOPs and review tools.
Personal Attributes
- Accurate
- Client focus
- Dependability
- Efficient interpersonal skills
- Excellent oral communication
- Excellent written communication
- Organized
- Reliability
- Team player
- Ability to multitask
- Analytical
- Interpersonal awareness
Qualifications
- At minimum, completion of a bachelors degree in law, business or science required; Master’s degree preferred;
- At minimum three (3) years of practical and related experience with at least 1 year on the job training.
- 1 year of experience drafting, interpreting and negotiating agreements and strong knowledge of contract clauses and legal, compliance, and risk assessment concepts
- Minimum one (1) year experience of practical and related experience with clinical trial agreements, data transfer agreements, confidentiality agreements, study orders etc.
- Minimum one (1) year of practical and related experience with adaptive clinical trials
- Working knowledge of relevant Canadian legislation, regulations and guidelines such as PHIPA, CAHO as well as international privacy laws such as GDPR, etc.
- Working knowledge of public and private organisation grants and funding terms such as CIHR, NIH, The Michael J. Fox Foundation, etc.
- Knowledge of risk management principles
- Ability to manage and prioritize projects simultaneously; to efficiently communicate, write, edit, analyze, negotiate and problem solve
- Familiarity with and/or experience in contracts or in an academic research environment is required
- Demonstrated negotiation and facilitation skills
- Experience in a Microsoft Office environment preferred
- Knowledge of the Sophia Knowledge Management System (WellSpring) and Adobe Sign are an asset
- Excellent verbal and written communication skills required
- Excellent interpersonal and customer service skills required
- Attention to detail/analytical thinking and excellent organizational abilities required
- Ability to manage personal timelines and priorities with minimal supervision required
This role supports a hybrid work environment, splitting time between the office and working from home. This position has opportunities for growth and long-term progression within the CTA Office and at UHN.
Why join UHN?
In addition to working alongside some of the most talented and inspiring healthcare professionals in the world, UHN offers a wide range of benefits, programs and perks. It is the comprehensiveness of these offerings that makes it a differentiating factor, allowing you to find value where it matters most to you, now and throughout your career at UHN.
- Competitive offer packages
- Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP https://hoopp.com/)
- Close access to Transit and UHN shuttle service
- A flexible work environment
- Opportunities for development and promotions within a large organization
- Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.).
- Dental plan
- Disability benefits
- Health care plan
- Vision care benefits
- Group insurance benefits
- Pension plan
- Maternity and parental benefits
- On-site amenities
- On-site recreation and activities
- Other benefits
- Paid time off (volunteering or personal days)
- Parking available
- Wellness program
Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN’s attendance management program, to be eligible for consideration.
All applications must be submitted before the posting close date.
UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.
Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.
All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire. Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN’s mandatory Vaccination Policy that is in effect.
UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.
We thank all applicants for their interest, however, only those selected for further consideration will be contacted.
Job Types: Full-time, Permanent
Pay: $74,428.00-$93,035.00 per year
Benefits:
- Company events
- Company pension
- Dental care
- Disability insurance
- Extended health care
- On-site gym
- On-site parking
- Paid time off
- Vision care
- Wellness program
Flexible Language Requirement:
- French not required
Schedule:
- Monday to Friday
Education:
- Bachelor’s Degree (preferred)
Language:
- English (preferred)
Work Location: In person
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