Clinical Research Professional
5 months ago
**Clinical Research Professional**:
**Primary Purpose**:The Clinical Research Professional (CRP) uses specialized knowledge in research regulations, institutional policy, and operational processes to provide administrative support for clinical research studies. The CRP participates in the development of clinical research projects, provides logístical guidance, and maintains ethical, operational, contractual, and regulatory compliance throughout the study lifespan. The CRP anticipates evolving industry practice and ensures long-term project sustainability when negotiating financial arrangements with research sponsors on behalf of the University of Saskatchewan and researchers.
**Nature of Work**:Reporting to the Director of Research through the Clinical Research Lead this position is part of a cohesive, cross-unit team providing excellent, proactive service to CTSU clients and the Vice Dean Research Team. The CRP provides administrative support for the setup, maintenance, and completion of clinical research studies. The CRP provides clinical research expertise to sites and policy makers and acts as a liaison among investigators, research ethic boards, study staff, sponsors, and other regulatory and health agencies in the administration of clinical studies. The duties are complex, and the consequence of error is high, requiring a high level of attention to detail and involving considerable intellectual demands. The ability to work effectively in an evolving and innovative environment and the ability to balance competing deadlines, priorities, and tasks is critical to being successful in the position. The successful applicant will work collaboratively within a team as well as independently and must have the ability to work under pressure in a fast-paced environment while balancing competing deadlines and multiple projects simultaneously. This position requires considerable professional judgment and excellent communication skills. The CRP will need to be flexible to meet the expectations of CTSU clients, team members within the OVDR, the College of Medicine, and beyond.
**Accountabilities**
- Work collaboratively with CTSU and OVDR Team members to support and achieve the goals and visions of the unit for productivity, profitability, and customer service.
- Act as an expert in Clinical Trial operations, recognizing logístical challenges and creating strategies to overcome obstacles, including those arising from regulatory review and audits.
- Assist in planning of CTSU fee structures, types of services offered, projects accepted or rejected, etc.
- Determines the steps, order and timing required for study start-up activities. Ensures that contract, budget, regulatory, operational, and ethical approvals are in place prior to project initiation.
- Identifies the applicable regulations, ethical requirements, health region departments and clinical trial registration requirements for each project.
- Applies for ethical approval, health region operational approval, Health Canada authorization, and clinical trial registration on behalf of investigators, as needed.
- Maintains ethical, operational, contractual, and regulatory compliance throughout the study lifespan.
- Assess clinical site costs to compile study budget estimates. Ensures consideration is given to evolving industry practice in developing budget estimates.
- Negotiates study budgets with sponsors using a variety of adaptive negotiation strategies.
- Assists with study payment reconciliation to ensure all payments are received.
- Manages communication between all relevant stakeholders, including investigators and their study staff, sponsors, contract research organizations, research ethics boards, health regions, regulators and other departments as required.
- Demonstrate a commitment to teamwork and positivity, along with an ability to create and nurture positive working relationships.
- Exercise decision-making and problem-solving to ensure priorities and deadlines are met and take initiative to move beyond completion of assigned tasks to plan for future changes or requirements.
- Maintain up-to-date knowledge/expertise on all policies and procedures regarding Clinical Trials.
- Ensures all research projects under assigned portfolio are at current status
- Provide excellent research and administrative support to the CTSU and OVDR through undertaking of other assigned research projects and tasks as required.
**Qualifications**
Knowledge of applicable laws and regulations governing clinical studies, including the Canada Food and Drug Regulations, Tri-Council Policy Statement, Good Clinical Practice (GCP) guideline and other relevant ethical, medical, and scientific standards would be considered an asset.
**Experience**:A minimum of two years of experience in the field of clinical research is required. Experience working with investigator-initiated studies as well as industry-driven, Health Canada-regulated clinical trials is preferred. Experience in
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