Senior Research Coordinator
Baycrest
Toronto, Ontario, Canada
139.5K $-189.5K $ / an (estimé)
Temps plein
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.
Il y a 6 jours