Clinical Research Coordinator Diagnostic Imaging

Position Overview

Under the supervision of Director of Cyclotron and Radiopharmacy Program the Clinical Research Coordinator is responsible for:

• Working with the Director to support the clinical trials for new radiopharmaceuticals ensuringthat clinical trials are conducted according to the Good Clinical Practices (GCP).
• Compiling organizing formatting evaluating and submitting to regulatory agencies the documents required for clinical trials applications (CTAs) and other ongoing research.
• Coordinating submissions to the Research Ethics Boards (REBs).
• Organizing and maintaining all regulatory documents for clinical trials including master files and adverse event reporting.
• Ensuringall procedures and related documents required to conduct a clinical trial are in place.
• Actingas a liaison between internal and external clinical investigators and site staff on all trial related issues organizinginternal and external monitoring and auditing functions assuringcompleteness and accuracy of all raw data data analysis and clinical reports for clinical trials.
• Ensuring document control is established and maintained in all areas of the program including SOPs forms worksheets and labels.
• Performingadministrative duties as related to Research and Operations.
• Working with the Director to support clinical research programs on the synthesis and properties of radiotracers for clinical and research applications.
• Designing and synthesizingradiopharmaceuticals in research lab including small molecules peptides and antibodies labeled with isotopes such as 18F 11C 68Ga 64Cu and 89Zr.
• Developing and optimizing radiolabeling protocols to improve yield purity and stability.
• Operating and maintaining key instruments used for research and clinical production such as HPLC GC TLC and automated synthesis modules.
• Collaborating with clinical and basic science departments to evaluate radiopharmaceuticals in vitro and in vivo contributing to biodistribution imaging and dosimetry studies.
• Preparingdocumentation for regulatory submissions including method validation reports and batch production records.
• Supporting the clinical operations specifically manufacturing and quality control of radiopharmaceuticals and equipment electronic controls.
• Performing production and quality control testing of radiopharmaceuticals as required.
• Developing Standard Operating Procedures (SOPs) for radiopharmaceutical production and Quality control for clinical and research purposes.
• Performing equipment validations to ensure smooth operations.
• Contributingto the research and development (R&D) and introduction of new radiopharmaceuticals for clinical use including designing and validating production methods.
• Analyzingdata from experiments drawing conclusions and makingrecommendations based on findings.
• Supporting manuscript preparation presentations and submissions for scientific publications.
• Training students research assistants and technicians in radiochemistry techniques.
• Adheringto all safety and health regulations and safe work practices.
• May be required to perform other duties and functions related to this job description not exceeding above stated skills and capabilities.

Experience

• A minimum of 2 years experience in a clinical or research positron emission radiopharmaceuticals (PERs) laboratory.
• At least 2 years of experience in a Good Manufacturing Practices (GMP) environment.
• Hands-on experience in the synthesis and quality control of radiopharmaceuticals.
• Proficiency with analytical techniques such as HPLC GC and TLC.
• Experience in research article writing and clinical research/data management software would be an asset.
• Experience with the Canadian regulatory framework including both Health Canada and the Canadian Nuclear Safety Commission (CNSC) would be an asset.

Education (Degree/Diploma/Certificate)

• Bachelor of Science degree or an equivalent combination of education and experience as recognized by HSC required.

Certification/Licensure/Registration

• Required to be designated as a Nuclear Energy Worker relative to applicable Canadian Nuclear Safety Commission (CNSC) legislation.

Qualifications and Skills

• Ability to work independently with minimal supervision required.
• Excellent oraland written communication skills including demonstrated skills in technical writing.
• Self-motivation with the ability to analyze situations set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment.
• An ability to work well both independently and within and across teams.
• Competency with computer applications such as Microsoft Office and information and document management systems.
• A high level of professionalism demonstrated by an ability to communicate effectively and to develop and maintain respectful and collaborative relationships with team members academic and industry researchers service providers and stakeholders.
• Advanced computer skills including word processing data management spreadsheets etc. required.
• Excellent time management and analytical skills required.

Physical Requirements

• Ability to perform the essential physical requirements of the position.
• The incumbent may be exposed to radiation (which will be kept as low as reasonably achievable).