Senior Clinical Research Coordinator

at  Queens University

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JOB SUMMARY

Reporting to the Director of Research, the Senior Clinical Research Coordinator is responsible for managing and coordinating the administration of new and ongoing, clinical trials for the Department of Anesthesiology and Perioperative Medicine. The incumbent will assist in managing the conduct and implementation of various clinical research trials in human subjects per protocol and under the guidance of various Principal Investigator(s). Duties may include but are not limited to review of relevant published literature, preparation of written summaries of literature reviews, preparation of ethics and institutional approval applications, collection, storage and analysis of research data, participation in experimental design and optimization of Principal Investigator (PI) initiated research protocols, and use of independent judgement to adapt procedures as the need arises. Responsibilities may also include the development and preparation of presentations for use in information and training sessions and professional conferences and communication/liaison with external agencies and institutions regarding multi-centre project research. The incumbent will participate in 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.
This position operates out of Kingston Health Sciences Centre -Kingston General Hospital, with occasional travel to Hotel Dieu Hospital and Providence Care Centre.
The schedule for this position requires the incumbent to work flexible hours, as required in support of ongoing research projects. This position will require occasional work on evenings, nights, weekends.

REQUIRED QUALIFICATIONS:

• Master’s degree in a relevant field or combination of related education and experience.
• 5 years of previous experience working as a clinical trial coordinator conducting clinical trials in human subjects in a health care setting.
• Previous experience involving investigational drugs/devices, informed consents, and data collection in human subjects in a hospital clinical setting. Knowledge of medical terminology.
• Familiarity with data analysis (qualitative and quantitative).
• Understanding of research design, procedures, guidelines, and standards governing clinical research.
• Completion of GCP, Division 5 & TCPS 2 CORE training. 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 required.
• 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.
• Interviewing skills for data collection.
• Well-developed attention to detail 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.

• Manages and oversees the day-to-day coordination of clinical trial activities in human subjects 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.
• Promotes an awareness and understanding of trial design, goals and procedures and critically evaluates incoming information for accuracy, relevance and prioritization.
• Plans and manages 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.
• 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.
• Designs, tests, and implements experimental protocols under the guidance of various PI’s. Conduct procedures, observe and record results. Develop and maintain data logs. Uses independent judgement to adapt procedures as the need arises. Participates in experimental design and optimization, as required by the PI.
• Collaborates on solutions to improve existing processes, and lead the implementation of solutions.
• Plans and manages 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.
• Maintains research records of study activity, including (but not limited to) electronic databases, trial master files, and other essential documentation.
• Liaises with other staff, labs, and outside agencies in order to stay aware of developments and foster collaborative research efforts.
• Reviews literature related to the project topics, prepares summaries of these reviews and collaborates with research teams to determine the impact on research projects.
• Assists with preparation of quarterly and annual reports to funding agencies.
• Develops and prepares resource materials (products of the research). Collaborates with research teams to prepare presentation materials. Presents results on behalf of project teams and provide regular updates at team meetings.
• Receives and stores investigational products in accordance with applicable regulatory requirements. Maintains records of investigational product delivery, inventory, use by participants, return to the sponsor, and disposal of unused products. Explains the correct use of the investigational product/devices to the participants. Reconciles and archives accountability records at the completion of the study.
• Carrie out project plans within allocated budgets.
• Performs routine financial transactions including (but not limited to) invoicing and account reconciliations, bookkeeping, participant reimbursement, and compensation.
• Communicates with participants and families on study-related issues throughout the lifecycle of the study. Liaises with clinical staff as needed.
• Assists with developing and delivering project-specific training as required.
• Attends educational events and meetings to advance expertise and maintain certifications.
• Ensures all equipment and supplies needed for the study are in stock and in good working order, orders study supplies as required, and maintains emergency products and supplies for the unit as applicable.
• Supervises junior staff and students, as needed specific to each project. Allocates responsibilities and tasks to junior staff and students and coordinates activities of team members.
• Performs administrative duties including scheduling, ordering supplies, bookkeeping, and record keeping.
• Undertakes other duties in support of the department.

Senior Management Administration

• Provides work direction, and technical/functional guidance to staff. Schedules and assigns work, and oversees its completion. Coordinates and monitors work flow.
• Schedules and approves, or recommends the approval of, employees’ hours of work, overtime and absences. Monitors and oversees employee attendance.
• Participates in screening and interviewing job candidates, and providing input into staff selection.
• Reviews assignments and provides feedback on work to employees. Provides input on work performance to management staff.
• Provides orientation and on-the-job training to employees in the unit. Provides coaching and feedback on work quality issues, providing related day-to-day supervision. Escalates unresolved performance and/or disciplinary matters to management.
• Manages quality assurance initiatives through the development and maintenance of standard operating procedures (SOPs) and standardized document templates to ensure trial adherence. Ensures annual review of relevant Standard Operating Procedures, the development of new procedures as needed and the ongoing training of staff and principal investigators.
• Recommends effective changes and modifications to unit policy and procedures.