Clinical Research Coordinator - Level 4 - Cf Specialist

Staff - Non Union

Job Category
M&P - AAPS

Job Profile
AAPS Salaried - Research and Facilitation, Level A

Job Title
Clinical Research Coordinator - Level 4 - CF Specialist

Department
Dell Laboratory | Department of Paediatrics | Faculty of Medicine | Provost and VP Academic

Compensation Range
$5,365.42 - $7,709.92 CAD Monthly

The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.

Posting End Date
November 21, 2024

Note: Applications will be accepted until 11:59 PM on the Posting End Date.

Job End Date

Nov 30, 2025

This position is expected to be filled by promotion/reassignment and is included here to inform you of its vacancy at the University.

This offer is conditional upon successful completion of a Criminal Record Check.

Note: Only the Full Time Compensation Range is displayed on the job posting details advertised on the UBC Career sites. Specific position details regarding part time positions with prorated compensation should be manually added to the Additional Job Description field.

Clinical Research Coordinator - Level 4 - CF Specialist
AAPS Salaried - Research and Facilitation, Level A
At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.

Job Summary
This full-time Clinical Research Coordinator - Level 4 - Cystic Fibrosis Specialist position is responsible for management industry-sponsored Cystic Fibrosis (CF) clinical trials and sustaining the site relationship with CF CanACT within the Division of Respiratory Medicine at BC Children's Hospital. As a senior member of the CF research team, you will oversee these specialized studies, ensuring compliance with all CF-specific regulatory and ethical standards. In addition, you will collaborate with the Program Manager in the management of the clinical trial's finances and budgets. This leadership role requires expert coordination skills, a deep understanding of CF research, ethics, and regulatory requirements, as well as strong financial management abilities.

Organizational Status

• Direct Report To: Principal Investigator (for assigned studies) and the Research Manager of the Respiratory Research Team.
• Works Closely With: Ethics and Regulatory Coordinator, Program Manager, clinical staff (nurses, fellows, clerks, students), external vendors/CROs, CF CanACT.

Work Performed

Study Coordination and Execution and Compliance:

• Oversee all phases of all multiple CF clinical trials including feasibility assessments, participant recruitment, start-up, initiation, conduct, and close-out.
• Provide advice on site feasibility for clinical trials, determining protocol requirements and site resources. Draft reports, contracts and assist with contract negotiations and budget planning
• Oversee the adherence to CF-specific protocols, provide advice, and facilitate patient engagement strategies for long-term CF management studies.
• Manage day-to-day operations of CF clinical trials, including data collection, safety reporting, monitor visits and protocol amendments.
• Collaborate with the Ethics and Regulatory Coordinator to draft and submit protocols, safety reports, reviews, Informed Consent Forms and all other study related materials to institutional ethics boards and Health Canada (when applicable).

Financial Oversight:

• Collaborate with the Ethics and Regulatory Coordinator to draft and submit protocols, safety reports, reviews, Informed Consent Forms and all other study related materials to institutional ethics boards and Health Canada (when applicable).
• Lead the financial management of clinical trials, evaluating project plans, grant budgets, and timelines and ensure accurate fund allocation.

Leadership:

• Provide training and guidance to junior staff and other coordinators related to study start-up, regulatory compliance, and ethical management, with a focus on the complexities of CF research and patient care.
• Act as a representative at CF CanACT meetings, committees, and with industry leaders, promoting the research team and attracting new clinical trial opportunities to the site.

Additional Responsibilities:

• Provide educational and training presentations to junior staff as well as internal and external stakeholders.
• Act as secondary coordinator for other disease indications when required by research manager.

Consequence of Error/Judgement
Exercises judgement in work methods for assignments. Errors made could influence the ability of the PI to meet critical deadlines, compromise the results of research projects and affect funding applications, thereby impacting the credibility of the Investigator and potentially increase risks to the patient population. Poor decisions may be damaging to the reputation of and cause financial loss to the Principal Investigator, The Centre, the Research Institute and the University.

Supervision Received
Works under general direction within established policies, procedures and standards. Work reviewed against task objectives and conformity to standards.
Supervision Given
Direct Supervision of Junior Research Coordinators can be expected in addition to providing educational training and expert guidance as noted above.

Minimum Qualifications

• Undergraduate degree in a relevant discipline. Minimum of two years of related experience, or an equivalent combination of education and experience.
• Willingness to respect diverse perspectives, including perspectives in conflict with one's own
• Demonstrates a commitment to enhancing one's own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

• A degree in life sciences, clinical research, or a related field is preferred.
• Significant experience coordinating Cystic Fibrosis clinical trials or other chronic respiratory disease studies, with a focus on industry-sponsored trials.
• Proven ability to manage the financial aspects of trials, including invoicing, budget tracking, and reconciliation.
• Experience with ethics submissions and regulatory processes, particularly Health Canada and ICH-GCP guidelines.
• Demonstrated leadership experience in a clinical research setting, with cross-functional team management and staff mentoring.
• Strong interpersonal and communication skills, particularly with industry sponsors and internal stakeholders.
• Ability to maintain meticulous regulatory documentation and ensure audit readiness.
• Proven ability to identify and resolve study-related issues effectively.