Manager: Clinical Research

JOB TITLE: Manager

DEPARTMENT: Clinical Research

PROGRAM: Academic & Research Impact

LOCATION: RLHC

POSITION SUMMARY

Reporting to the Director of Academic and Research Impact, the Manager of Clinical Research oversee all aspects of funded research to ensure processes are developed, monitored and maintained that optimize human and financial resources, the health and safety of all research participants and personnel, and high quality research performance that meets or exceeds regulatory compliance standards. The Manager promotes effective collaboration with clinical, academic, research and industry partners and provides leadership for the coordination, evaluation and continual improvement of HSNRI's research operations.

REPORTING:

Under the general direction of the Director of Academic & Research Impact

DIRECT REPORTS:

Clinical Research Staff

Research personnel hired for individual research studies under a Principal Investigator

RESPONSIBILITIES:

Operations Management

Responsible for the overall day-to-day operations of Clinical Research. Directs, coordinates and supervises all business and regulatory aspects of clinical research activities. Assists with execution and oversight of local clinical trial activities in compliance with ICH/GCP and appropriate regulations, HSNRI policies and procedures, and quality standards. Works in close collaboration with HSN departments, physicians, REBs and Regulatory Authorities to achieve expected outcomes. Ensures the protection of confidential research information in compliance with organizational policies, TCPS, and PHIPA.

Financial Management

Develops  and manages the departmental operating budget and specific study/project budgets by monitoring budget performance, financial resources, workload and financial forecasting to ensure trials and research projects meet expected financial performance.

Works with Research Services and Primary Investigators in the development, negotiation and completion of Clinical Trial Agreements (CTA).

Conducts budget analyses, reporting variances and putting plans in place to ensure a balanced financial position.

Ensures processes are established and maintained to track research revenues and expenditures.

Oversees and authorizes purchasing of equipment and supplies following procurement policies.

Ensures Principal Investigators understand financial obligations and follow HSNRI policies, TCPS and associated funding agreements.

Human Resources Management

Manages human resources including recruitment, orientation and training.

Guides, motivates, and supervises staff, developing performance standards, and evaluating and managing performance.

Promotes professional development within budgeted resources.

Oversees human resource functions including scheduling, payroll, vacation approvals, and compensation adjustments.

Ensures appropriate communications with staff to promote engagement and team cohesion, addressing issues impacting research operations.

Research Compliance

Ensures research compliance standards are met.

Promotes effective collaboration, ensuring adherence to agreements, working with collaborators and partners to resolve issues.

Develops and maintains templates and resources to guide clinical research staff in the conduct of clinical research to facilitate regulatory compliance.

Monitors compliance to HSNRI policies, developing and updating policies as required.

 Performs other duties as required.

QUALIFICATIONS:

EDUCATION AND TRAINING: 

Minimum of a four (4) year Bachelor's Degree in a relevant field, from an accredited university.

A Master's Degree is preferred.

Ministry of Labour "Worker Health and Safety Awareness in 4 Steps" training certificate is required.

EXPERIENCE: 

Minimum of five (5) years' experience working within a health care or clinical research environment.

Minimum of two (2) years' experience working in a leadership/supervisory role, preferably in a health care or clinical research environment.

Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals certification (ACRP) preferred.

KNOWLEDGE/SKILLS/ABILITIES: 

In-depth knowledge of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans; ICH Good Clinical Practice: Consolidated Guideline, and the requirements of U.S. federal agencies, and has experience in the conduct of human research.

Demonstrated time management, prioritization, organization, and problem-solving skills.

Strong interpersonal and communication skills.

Proven ability to deal effectively with challenging situations using sound judgment, tact, diplomacy and confidentiality.

Advanced budgeting and financial monitoring experience.

Strong electronic data management skills and advanced skills in Microsoft Office programs.

Demonstrated ability to independently identify issues, plan improvements, and measure success.

Demonstrated knowledge of relevant legislation and management principles, conflict management and resolution, system needs analysis and organizational assessment.

Demonstrated commitment to the safety of co-workers and patients.

PERSONAL SUITABILITY: 

Demonstrated commitment to ongoing professional development.

Demonstrated professionalism in dealing with confidential and sensitive issues.

Demonstrated positive work record and excellent attendance record.

Ability to meet the physical and sensory demands of the job.

Ability to travel between local sites.

OTHER: 

Bilingualism is an asset. 

Annual Salary $117,973 – $138,792 commensurate with experience