Senior Research Coordinator

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.
25 days ago