Senior Research Coordinator

3 weeks ago

Toronto, Canada Baycrest Full time
Responsibilities include but are not limited to:Responsibilities include but are not limited to: Coordinates, monitors and supervises all study activities to ensure proper execution of assigned clinical research trials and to ensure that study protocols, SOPs, ICH-GCPs and regulatory requirements are met. Acts as a Leader by advising CRCs, Study Preparation Associates, Clinical Research Technicians, and Safety Staff on proper trial execution based on protocol, SOP, and regulatory requirements. Conducts CRC and RA training. Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate Respond to queries by internal departments on trial conduct Participates in review and development of study protocols, SOPs, and internal procedures Analyzes and develops action plans to address QC/QA findings, including development of CAPA reports Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements Performs CRC, RA and/or Study Preparation Associate duties if required Maintains adequate, accurate, complete and legible records Detailed review of study participant and study documentation, CRFs and source documents Conducts Protocol training for clinical research staff and Investigators. Works with QC and QA during audits and audit follow-ups Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.) Performs other tasks as assigned and as training and experience allow Serve as primary contact for multiple studies/sites Prepare for and conduct study monitor visits and audits Serves as a liaison to physicians, investigators, patients and other staff members regarding the research process and individual protocols Submit and Review Institutional Review Board documents Strategizes and helps troubleshoot to correct problems Escalates issues as needed to supervisor


Qualifications include but are not limited to:

3-5 years work experience as a Clinical Research Coordinator Certification as a Clinical Research Professional (SOCRA, ACRP, etc.) Current GCP and familiarity with Health Canada, FDA, ICH GCP regulations Current GCP, Health Canada Part C Division 5, IATA certifications Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience. Ability to work in a fast paced environment with a high degree of organization. Experience with Microsoft Office (Word, Excel, Power point, etc.) Phlebotomy certification

Required Skills:

Excellent organization and attention to detail Quick and eager learner Ability to work independently Strong critical thinking Excellent oral and written communication 3-5 years of experience in related field Working knowledge of research methodology/medical terminology Meticulous work ethic and attention to detail, with excellent time-management and organizational skills. Ability to manage competing demands of short and long-term projects led by numerous individuals, directing multiple varied assignments, independently coordinating and prioritizing relevant projects, tasks and responsibilities. Highly motivated and adaptable with an ability to take initiative and work well independently and as part of a multidisciplinary team. Ability to produce high quality work while meeting deadlines in accordance to CTU standards. Ability to maintain confidentiality.

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