Clinical Research Professional Manager
Apply NowCompany: University of Saskatchewan
Location: Saskatoon, SK S7H 5T5
Description:
Clinical Research Professional Manager
Primary Purpose: The Clinical Research Professional (CRP) Manager uses specialized knowledge in research regulations, institutional policy, and operational processes to provide administrative support for clinical research studies. The CRP Manager participates in the development of clinical research projects, provides logistical guidance, and maintains ethical, operational, contractual, and regulatory compliance throughout the study lifespan. The CRP Manager provides knowledge and expertise to facilitate the achievement of priorities, effective communication, and ensure the success of the ongoing activities of the Director and Vice Dean of Research. This position will serve as part of the clinical trials leadership team identifying issues, problem-solving, and implementing solutions. The CRP Manager fosters collaboration among healthcare professionals, principal investigators, and research teams while advocating for patient well-being and advancing the University of Saskatchewan's research objectives.
Nature of Work: Reporting to the Director of Research, this position is part of a cohesive, cross-unit team providing excellent, proactive service to Clinical Trial Support Unit (CTSU) clients and the Vice Dean Research Team. The position will provide strategic oversight and lead the CTSU's team of Clinical Research Professionals in addition to maintaining a reduced CRP portfolio. The CRP Manager will model behavior and coach team members to proactively engage with principal investigators and industry sponsors to understand their needs and priorities while strategically advancing the College goals. 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. This position requires considerable professional judgment and excellent communication skills. The CRP Manager will need to be flexible to meet the expectations of CTSU clients, team members within the OVDR, the College of Medicine, and beyond.
Accountabilities
Leadership
Education
Research Coordination
Qualifications
Education: A Bachelors degree in Health sciences or related discipline is required. A combination of education and experience may be considered. Current certification with the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) is required. Candidates meeting all other criteria will be given two years to complete certification.
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 clinical trial monitoring and database management would be an asset.
Skills: Exceptional organizational skills with the proven ability to work on multiple projects with competing demands to meet deadlines; demonstrated aptitude for successfully working in a team oriented environment; demonstrated sound judgment, tact, discretion, and professional integrity; exemplary interpersonal and communication (verbal and written) skills; strong attention to detail; ability to work independently, take initiative and anticipate future needs, issues and events; proven problem-solving abilities; conflict management skills; ability to work within new software systems and evolving processes; experience with financial account management and a demonstrated knowledge of Microsoft Office Suite (Outlook, Word, Excel and PowerPoint), Sharepoint, and strong internet research skills.
Department: College of Medicine - DnOffce
Status: Term 2 years with the possibility of extension or becoming permanent
Employment Group: ASPA
Shift: Mon-Fri, 8:00-4:30
Full Time Equivalent (FTE): 1.0
Salary: The salary range, based on 1.0 FTE, is $85,555.00 - 142,503.00 per annum. The starting salary will be commensurate with education and experience.
Salary Family (if applicable): Managerial
Salary Phase/Band: Phase 3
Posted Date: 2/24/2025
Closing Date: 3/9/2025 at 6:00 pm CST
Number of Openings: 1
Work Location: On Campus
The University is committed to employment equity, diversity, and inclusion, and are proud to support career opportunities for Indigenous peoples to reflect the community we serve. We are dedicated to recruiting individuals who will enrich our work and learning environments. All qualified candidates are encouraged to apply; however, in accordance with Canadian immigration requirements, Canadian citizens and permanent residents will be given priority. We are committed to providing accommodations to those with a disability or medical necessity. If you require an accommodation to participate in the recruitment process, please notify us and we will work together on the accommodation request. We continue to grow our partnerships with Indigenous communities across the province, nationally, and internationally and value the unique perspective that Indigenous employees provide to strengthen these relationships. Verification of Indigenous Membership/Citizenship at the University of Saskatchewan is led and determined by thedeybwewin | taapwaywin | tapwewin: Indigenous Truth policy and Standing Committee in accordance with the processes developed to enact the policy. Successful candidates that assert Indigenous membership/citizenship will be asked to complete the verification process of Indigenous membership/citizenship with documentation. The University of Saskatchewan's main campus is situated on Treaty 6 Territory and the Homeland of the Mtis. We pay our respects to the First Nations and Mtis ancestors of this place and reaffirm our relationship with one another. Together, we are uplifting Indigenization to a place of prominence at the University of Saskatchewan.
Primary Purpose: The Clinical Research Professional (CRP) Manager uses specialized knowledge in research regulations, institutional policy, and operational processes to provide administrative support for clinical research studies. The CRP Manager participates in the development of clinical research projects, provides logistical guidance, and maintains ethical, operational, contractual, and regulatory compliance throughout the study lifespan. The CRP Manager provides knowledge and expertise to facilitate the achievement of priorities, effective communication, and ensure the success of the ongoing activities of the Director and Vice Dean of Research. This position will serve as part of the clinical trials leadership team identifying issues, problem-solving, and implementing solutions. The CRP Manager fosters collaboration among healthcare professionals, principal investigators, and research teams while advocating for patient well-being and advancing the University of Saskatchewan's research objectives.
Nature of Work: Reporting to the Director of Research, this position is part of a cohesive, cross-unit team providing excellent, proactive service to Clinical Trial Support Unit (CTSU) clients and the Vice Dean Research Team. The position will provide strategic oversight and lead the CTSU's team of Clinical Research Professionals in addition to maintaining a reduced CRP portfolio. The CRP Manager will model behavior and coach team members to proactively engage with principal investigators and industry sponsors to understand their needs and priorities while strategically advancing the College goals. 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. This position requires considerable professional judgment and excellent communication skills. The CRP Manager will need to be flexible to meet the expectations of CTSU clients, team members within the OVDR, the College of Medicine, and beyond.
Accountabilities
Leadership
- Provides leadership and oversight of the CRP positions in the CTSU and ensures those team members have a sound understanding of College of Medicine (CoM) leadership's priorities
- Lead the day-to-day activities of the CRP team to ensure compliance with both internal policies and external requirements
- Holds a position on the operations team whose purpose is to move forward the strategic goals of the unit and attends all relevant meetings
- Recommend, develop, and implement changes in policies and procedures to improve administrative processes. Continually evaluate and assess the adequacy of services provided to researchers to initiate and oversee any changes in practice or procedures to improve service
- Identify strategic alliance partners and develop long-term, sustainable relationships
- Facilitate the resolution of complex issues, emerging opportunities, and unpredictable events using expertise and an aptitude for intuitive and constructive problem solving
- Prioritize projects and activities, delegate responsibility where appropriate, and allocate work to direct reports
- Provide or delegate coverage for the portfolios of direct reports during planned and unexpected leaves of absence to ensure continuity in clinical research activities
- Support the recruitment of qualified, new CRPs
- Demonstrate a commitment to teamwork and positivity and create and nurture positive working relationships
- Oversee CRP team of professionals including;
- Conduct and document annual performance meetings for direct reports
- Prepare presentations, reports, and briefing notes to ensure the Director of Research and Vice Dean Research are prepared for all relevant situations
Education
- Lead the on-boarding and specialized training of new CRPs
- Develop and deliver a training package for CRPs who are new to the area of clinical trials
- Creates and maintains standard operating procedures and guidelines to support clinical research functions and goals
- Escalate issues as required to the attention of the Director of Research with the purpose of identifying threats and brainstorming solutions
- Maintain expertise in policies and procedures regarding Clinical Trials and share relevant updates, trends, and insights about industry developments to the CRP team
Research Coordination
- Act as an expert in Clinical Trial operations, addressing logistical challenges and creating strategies to overcome obstacles, including regulatory reviews and audits
- Assist with the CTSU fee structures, services offered, and project acceptance criteria
- Serve as a liaison among investigators, research ethics boards, study staff, sponsors, and regulatory and health agencies to facilitate clinical study administration
- Provide professional advice and guidance to the research community and policymakers on regulations, policies, and practical applications
- Coordinate study start-up activities, ensuring contract, budget, regulatory, operational, and ethical approvals are in place before project initiation
- Identify and manage applicable regulations, ethical requirements, health region departments, and clinical trial registration needs for each project
- Apply for ethical approval, operational approval, Health Canada authorization, and clinical trial registration on behalf of investigators as required
- Maintain compliance with ethical, operational, contractual, and regulatory requirements throughout the study lifespan
- Develop research protocols, consent forms, case report forms, subject recruitment tools, and other documents in accordance with regulatory requirements
- Assess clinical site costs and compile study budget estimates, incorporating evolving industry practices
- Negotiate study budgets with sponsors using adaptive strategies and assist with payment reconciliation to ensure all payments are received
- Exercise decision-making and problem-solving to prioritize tasks, meet deadlines, and proactively plan for future changes or requirements
- Provide research and administrative support to CTSU and OVDR, undertaking additional research projects and tasks as required
Qualifications
Education: A Bachelors degree in Health sciences or related discipline is required. A combination of education and experience may be considered. Current certification with the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) is required. Candidates meeting all other criteria will be given two years to complete certification.
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 clinical trial monitoring and database management would be an asset.
Skills: Exceptional organizational skills with the proven ability to work on multiple projects with competing demands to meet deadlines; demonstrated aptitude for successfully working in a team oriented environment; demonstrated sound judgment, tact, discretion, and professional integrity; exemplary interpersonal and communication (verbal and written) skills; strong attention to detail; ability to work independently, take initiative and anticipate future needs, issues and events; proven problem-solving abilities; conflict management skills; ability to work within new software systems and evolving processes; experience with financial account management and a demonstrated knowledge of Microsoft Office Suite (Outlook, Word, Excel and PowerPoint), Sharepoint, and strong internet research skills.
Department: College of Medicine - DnOffce
Status: Term 2 years with the possibility of extension or becoming permanent
Employment Group: ASPA
Shift: Mon-Fri, 8:00-4:30
Full Time Equivalent (FTE): 1.0
Salary: The salary range, based on 1.0 FTE, is $85,555.00 - 142,503.00 per annum. The starting salary will be commensurate with education and experience.
Salary Family (if applicable): Managerial
Salary Phase/Band: Phase 3
Posted Date: 2/24/2025
Closing Date: 3/9/2025 at 6:00 pm CST
Number of Openings: 1
Work Location: On Campus
The University is committed to employment equity, diversity, and inclusion, and are proud to support career opportunities for Indigenous peoples to reflect the community we serve. We are dedicated to recruiting individuals who will enrich our work and learning environments. All qualified candidates are encouraged to apply; however, in accordance with Canadian immigration requirements, Canadian citizens and permanent residents will be given priority. We are committed to providing accommodations to those with a disability or medical necessity. If you require an accommodation to participate in the recruitment process, please notify us and we will work together on the accommodation request. We continue to grow our partnerships with Indigenous communities across the province, nationally, and internationally and value the unique perspective that Indigenous employees provide to strengthen these relationships. Verification of Indigenous Membership/Citizenship at the University of Saskatchewan is led and determined by thedeybwewin | taapwaywin | tapwewin: Indigenous Truth policy and Standing Committee in accordance with the processes developed to enact the policy. Successful candidates that assert Indigenous membership/citizenship will be asked to complete the verification process of Indigenous membership/citizenship with documentation. The University of Saskatchewan's main campus is situated on Treaty 6 Territory and the Homeland of the Mtis. We pay our respects to the First Nations and Mtis ancestors of this place and reaffirm our relationship with one another. Together, we are uplifting Indigenization to a place of prominence at the University of Saskatchewan.