Nature of Work: Reporting to the Director of Research, the Contract Specialist advises on a wide range of legal matters relating to clinical trials and develops a highly specialized knowledge base regarding the legal, regulatory, and ethical aspects of the conduct of clinical trials in Saskatchewan. The Contract Specialist supports researchers involved in clinical trials and may participate in local and national advisory groups. The Contract Specialist is able to perform in a fast-paced environment, able to create and reset priorities as the need arises, identify and raise issues before they become critical, and adjust quickly to the changes of a dynamic organization. The Contract Specialist must be able to work independently, demonstrate an ability to develop precedents and templates, and change and adapt processes in order to meet changing institutional and regulatory requirements. The Contract Specialist will identify and develop new relationships with industry and non-industry partners that support the goals and visions of clinical researchers.

Typical Duties or Accountabilities:

• Exercise a high degree of discretion and expertise in providing professional legal services, managing exposure to legal risks on behalf of USask, other CTSU institutional members, and researchers.
• Negotiate and draft a wide variety of legal agreements relating to clinical research and trials.
• Works cross functionally with Clinical Research Lead and the Clinical Research Professional team in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.
• Evaluates urgent matters and priorities and quickly readjusts strategies for workload management with the changing needs of the business.
• Identifies and proactively raises issues prior to them becoming critical or creating risk.
• Takes leading role in planning and implementing long-term strategic projects and initiatives to assist the parties to improve and evolve their participation in clinical trials.
• Provide advice with respect to USask institutional policies and policy development and anticipate and identify future needs or opportunities.
• Collaborates with the sponsor to ensure country specific laws and regulations are followed to minimize risk in clinical trials.
• Communicates and explains legal issues to internal and external parties in lay terms per USask guidelines.
• Works directly with the Contract Support Specialist who is the primary contact with external parties, sponsors, and stakeholders as required.
• Appraises contracts for completeness and accuracy and ensures adherence to USask guidelines; corrects documents and files changes to contracts. Additionally, this includes ensuring all budget negotiations for all contracts are compliant with Usask Overhead requirements.
• Works on the development of legal templates and various forms of contracts, including clinical trial contracts, sub-site agreements, confidential disclosure agreements, material transfer agreements, and data transfer agreements.
• Maintain thorough documentation and reporting of work, including accurate records of negotiations.
• Creates and maintains files for each contract.
• Creates, maintains, amends, and closes all contracts related items in the online University Research System (UnivRS), including the legal summary for each clinical trial.
• Completes all legal work associated with the Research Ethics Board submissions.
• Tracks contract workflow in the EDGE database in a timely and accurate manner and ensures that status updates are fully descriptive.
• Generates ideas and solutions to improve requested contract changes while appropriately partnering with sponsor for feedback and execution.
• Acts with consistency, timeliness, completeness, and professionalism in all interactions with Sponsors and Stakeholders.
• Exhibits proficiency in executing documents that are complete and accurate delivered within shorter timeframes.
• Exhibits proficiency in managing multiple projects with competing priorities.
• Represent USask, other CTSU institutional members, and researchers in relevant committees and organizations and builds sustainable relations with all stakeholders and researchers.
• Other duties as assigned by the Director of Research.

Education: The Contract Specialist, Clinical Trials, must hold a qualified law degree (JD, LL.B.), and be a member in good standing of the Law Society of Saskatchewan.

Experience: At least five years’ experience in related areas of practice is required. Experience with clinical trials or corporate law is preferred.

Skills: The Contract Specialist must possess excellent discretion and judgment because the impact of error associated with this work is considerable for the reputations and exposure to risk of USask, the CTSU’s other institutional members and researchers. The position is privy to and works with sensitive, highly confidential information. It requires effective and accurate exchange of specialized and complex information, as well as the ability to work under pressure in an environment involving a multiplicity of projects and tight timelines. The position requires dedication to professional excellence in order to ensure clinical trials meet or exceed the highest ethical and professional standards. The candidate must be proficient in MS Excel, Word and Outlook as they are essential to enable effective communication and preparation of materials and documents as needed.

Inquiries regarding this position can be directed to Megan Truscott at 306-966-6516.