Full-Time Research Contracts Specialist

Reporting to the Director of Clinical Research, the successful candidate will prepare and negotiate legal agreements for Osler research studies including 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 develop agreement strategies.

The position requires liaison with internal stakeholders such as the Research Ethics Board, Research Financial Services, and senior management for briefing and decision-making.

Duties also include developing SOPs and review tools.

With support 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, pharmaceutical companies, medical device companies, or CROs (Contracts Research Organizations).

Consulting with internal parties and negotiating with external parties as required, the Contracts Specialist will ensure 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 Osler's interests while maintaining a customer-service outlook toward researchers and their staff.

Accountabilities:

• Oversee day-to-day delivery and administration of contracts and agreements, and serve as the first point of contact for contracting needs.
• Receipt, review, and management of research agreements (clinical trial agreements, material transfer agreements, non-disclosure agreements, service agreements, data transfer agreements, etc.).
• Ensure all agreements comply with Osler’s institutional policies, research guidelines, and legislative requirements.
• Identify operational risks in contracts and develop recommendations for mitigation.
• Negotiate contractual financial terms on behalf of the Hospital, researchers, and third parties.
• Track and update contract management spreadsheets, maintaining executed agreements.
• Summarize contract details for internal stakeholders.
• Follow up with PIs/Coordinators and external parties to address delays and ensure timely contract processing.
• Understand research context and motivations of all parties.
• Finalize agreements and coordinate with external parties to obtain executed copies.
• Manage correspondence with PIs, staff, Hospital departments, governments, and corporate sponsors.
• Update agreement statuses.
• Ongoing administration and follow up of research agreements.

Qualifications:

• Minimum: Law degree or paralegal background with related experience, or Master's degree/recognized equivalent
• Minimum 3 years practical experience, with at least 2 years drafting, interpreting, and negotiating agreements (clinical trial agreements, data transfer agreements, confidentiality agreements, etc.)
• Familiarity with human research legislation and Canadian, US, and international guidelines (FDA, Health Canada, GCP, Tri-Council Policy Statement, PHIPA, etc.)
• Ability to prioritize competing demands with interruptions.
• Strong organizational, problem-solving, and communication skills (oral, interpersonal, written).
• Excellent attention to detail, ability to learn new skills
• Knowledge of medical terminology preferred
• Proficiency in MS Office (Excel, Word, Outlook)
• Demonstrates Osler Values: Respect, Excellence, Service, Compassion, Innovation, Collaboration

Preferred Skills:

• Experience drafting and negotiating research contracts.

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