Senior Clinical Research Coordinator

at  Queens University

ABOUT QUEEN’S UNIVERSITY

Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.
We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.
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JOB SUMMARY

Reporting to the Director of Research Operations, Queen’s Health Sciences (QHS), the Senior Clinical Research Coordinator is responsible for managing and coordinating the administration of new and ongoing, multi-center, multi-modality clinical trials for the Clinical Trials Support Unit (CTSU). The incumbent will assist in managing the conduct and implementation of various clinical research trials per protocol and under the guidance of various Principal Investigator(s). Duties may include but are not limited to the identification of eligible participants, the collection and coding of clinical data including that abstracted from clinical records and from interviews with research participants, liaising with hospital personnel, and faculty and staff to coordinate activities required to ensure the protocol is followed for each trial. Establish and maintain study databases and essential documentation, will work collaboratively with participating centres and trial committees (including investigators, clinical research associates, pharmacists), industry partners, and others in an evolving international clinical trials environment. Promotes an awareness and understanding of trial design, goals and procedures and critically evaluates incoming information for accuracy, relevance and prioritization.
This position will require travel to multiple sites in Kingston, including Kingston Health Sciences Centre (Kingston General Hospital and Hotel Dieu Hospital Sites) and Providence Care Centre.
This position will require occasional work on evenings, nights, weekends.

REQUIRED QUALIFICATIONS:

• Master’s degree in a relevant field.
• 5-7 years of previous experience working as a clinical trial coordinator conducting clinical trials. Previous experience involving investigational drugs/devices, informed consents, and data collection in a clinical setting.
• Understanding of research design, procedures, guidelines, and standards governing clinical research (e.g., Tri¬-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2); ICH Good Clinical Practice E6 (R2); Part C, Division 5 of the Food and Drug Regulations; Part 4 of the Natural Health Products Regulations; Part 3 of the Medical Devices Regulations, Ontario Personal Health Information Protection Act (PHIPA 2004); U.S. Code of Federal regulations titles 21 and 45).
• Certified Clinical Research Professional (through SoCRA or ACRP or equivalent organization) an asset.
• Biohazard training, Human Blood, Tissues, and Bodily Fluids and Transportation of Dangerous Good (TDG/IATA) course is considered an asset.
• Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:

• Interpersonal and communications skills (both verbal and written) to deal with a multidisciplinary team in a professional manner and to provide clear and accurate information.
• Respect diversity and promote inclusion in the workplace.
• Well-developed research skills, including the ability to locate, review, synthesize and summarize relevant research information.
• Ability to multitask, prioritize workload, and deal with multiple demands.
• Time-management, and organizational skills as well as the capacity to take initiative, solve problems and suggest solutions.
• Computer skills including Microsoft Office Suite (including Word, Excel, etc.), and understand the capabilities of evolving electronic data capture systems.
• Ability to work independently as needed.
• Ability to exercise sound judgment with regard to the need for supervision and guidance.
• Ability to work collaboratively with professionals in a team-oriented environment.
• Familiarity with data analysis (qualitative and quantitative).
• Interviewing skills for data collection.
• Attention to detail.
• Superior oral and written communication skills.
• Enthusiasm to learn new skills.
• Capacity to critically and accurately review and interpret medical data.
• Proficient in the use of webinar and teleconferencing technologies.

• This position manages and oversees the day-to-day coordination of clinical trial activities and plays a pivotal role in ensuring compliance with policies, guidelines, and regulatory requirements in collaboration with Principal Investigators, Sponsors, and Study Teams.
• Ensures deadlines are met, and that all research material is handled in accordance with established protocols, policies, and procedures.
• Planning and management of the development of study related documents including (but not limited to) protocols, research ethics board submissions, clinical trial regulatory applications, funding applications, site feasibility assessments, informed consent documents, safety/monitoring plans, start-up activities, recruitment strategies, pharmacy manuals, and training materials.
• Plan and manage the logistical aspects of the studies, including (but not limited to) identification of participants, recruitment, screening, enrollment of participants, obtaining consent, data collection, administering assessments/intervention as delegated per protocol; follow up with participants as required, completion of case report forms, and query resolutions.
• Maintain research records of study activity, including (but not limited to) electronic databases, trial master files, and other essential documentation.
• Liaise with laboratories regarding research findings; obtain and submit pathology and/or biology materials as required by protocol.
• Receive and store investigational products in accordance with applicable regulatory requirements. Maintain records of investigational product delivery, inventory, us by participants, return to the sponsor, and disposal of unused products. Explain the correct use of the investigational product/devices to the participants. Reconcile and archive accountability records at the completion of the study.
• Perform routine financial transactions including (but not limited to) invoicing and account reconciliations, bookkeeping, participant reimbursement, and compensation.
• Communicate with participants and families on study-related issues throughout the lifecycle of the study; liaise with clinical staff as needed.
• Assist with developing and delivering project-specific training as required
• Attend educational events and meetings to advance expertise and maintain certifications.
• Ensure all equipment and supplies needed for the study are in stock and in good working order; ordering study supplies as required; maintain emergency products and supplies for the unit as applicable.
• Conduct quality assurance checks, as required, to evaluate site and staff performance and ensure adherence to study protocols, study operation plans, and regulatory requirements.
• Coordinate the day-to-day activities of research support staff specifically engaged in the carrying out of research/clinical protocol; Act as point of contact for the research team who have questions.
• Senior Clinical Research Coordinators delegate work and ensure its completeness and accuracy to team members including Junior Clinical Research Coordinators and casual staff. Participates in the training and mentoring of new Clinical Research Coordinators and others.
• Answer general inquiries and refer problems to the Investigator(s); undertake other duties as delegated in support of the project.