Job Description
Reporting to the Director of Clinical Research, the successful candidate will prepare and negotiate legal agreements for Osler research studies including but not limited to clinical study agreements, confidentiality agreements, sub site / grant and collaboration agreements, grant agreements etc. The Research Contract Specialist will also review and assess study submissions by researchers to determine study complexity and requirements, and to develop agreement strategies. The position is also required to liaise with key internal stakeholders such as the Research Ethics Board, Research Financial Services and senior management for briefing and decision-making. Duties will also include the development of SOPs and review tools.
With support as required from Osler Legal Services, the Contract Specialist will review, negotiate, and administer a high volume of funding and related research agreements and proposals with granting agencies, collaborating institutions, research consortia and pharmaceutical companies, medical device companies or Contracts Research Organizations (CROs). Consulting with internal parties and negotiating with external parties as required, the Contracts Specialist will ensure that such agreements are consistent with Osler’s institutional and funding agency policies and do not expose Osler or its researchers to excessive administrative or financial risk. The Contracts Specialist will protect the interests of Osler while at the same time maintaining a customer-service outlook toward researchers and their staff.
Accountabilities :
- Responsible for overseeing the day-to-day delivery and administration of contracts and agreements, and serves as the first point of contact for staff with contracting needs;
- Receipt, review, and management of research agreements, including clinical trial agreements, material transfer agreements, non-disclosure agreements, service agreements, data transfer agreements and other research-related contracts;
- Ensure that all agreements comply with Osler’s institutional policies, guidelines on conducting research and legislative requirements;
- Identify operational risks that appear in contracts and develop recommendations to mitigate or avoid them;
- Negotiate contractual financial terms on behalf of the Hospital, its Researchers, and other third parties engaged with the hospital in order to come to an acceptable outcome for all parties;
- Track and update contract management spreadsheet, ensuring all copies of executed agreements are maintained and available; synthesize and summarize contract details for reporting to internal stakeholders;
- Follow up with the PI / Coordinator and the external parties to alleviate delays and ensure that all contracts are processed in a timely manner;
- Understand the context of the research as well as the motivations of all parties involved;
- Finalize the agreement and coordinate with the external party to obtain executed copies of the contract;
- Manage correspondence and exchange of information with PIs and their staff, Hospital departments, governments and corporate sponsors related to specific research projects;
- Update status of agreements by inputting most recent activity of a file;
- On-going administration and follow up of research agreements.
Qualifications
At minimum, a law degree or paralegal background with related experience or; a master’s degree or recognized equivalentMinimum three (3) years practical and related experience with at least 2 years of experience drafting, interpreting and negotiating agreements including clinical trial agreements, data transfer agreements, confidentiality agreements, etc. is preferredFamiliarity with legislation governing human research and knowledge of Canadian, US and international guidelines as they apply to clinical trial management (e.g. FDA and Health Canada regulations, Good Clinical Practices, Tri-Council Policy Statement, Personal Health Information Protection Act, etc.)Demonstrated ability to set priorities among competing and shifting demands with frequent interruptions. Must be highly organized and able to work independently to meet tight deadlines without sacrificing accuracy, customer service, collegiality, or ethicsExperience drafting and negotiating research contractsExcellent organizational and problem solving skillsAble to support closure on a tight schedule and provide timely analysis of resultsExcellent oral, interpersonal and written communication skillsExcellent attention to detail and proven ability to learn new skillsKnowledge of Medical terminology preferredExcellent knowledge of full suite of MS office programs (including Excel, Word, Outlook)Must demonstrate Osler Values of Respect, Excellence, Services, Compassion, Innovation and CollaborationAdditional Information
Hours : Currently Days (subject to change in accordance with operational requirements)
Annual Salary : Minimum : 85,839.00
Maximum : 107,308.50
Remote First Role : Roles that can function primarily remotely but require essential, occasional onsite work
Application deadline : February 12, 2025
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Osler values inclusivity and diversity in the workplace. We welcome and encourage applicants from diverse backgrounds. We are committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act. If you require an accommodation at any stage of the recruitment process, please notify Human Resources at human.resources@williamoslerhs.ca .
While we thank all applicants, only those selected for an interview will be contacted. Any information obtained during the course of recruitment will be used for employment recruitment purposes only, and not for any other purpose.