Clinical Research Project Coordinator

4 weeks ago

Hamilton, Ontario, Canada McMaster University Full time

Job Overview:

The Clinical Research Project Coordinator is responsible for the execution, oversight, refinement, evaluation, and reporting of various clinical research initiatives. This role serves as a vital resource for the formulation of protocols, study documentation, operational management, and methodological strategies.

Key Responsibilities:

  • Utilize specialized expertise and scientific principles to assess, critically evaluate, and interpret existing literature.
  • Contribute to the writing of scientific manuscripts, funding applications, and abstracts.
  • Coordinate the efforts of research personnel and resources to ensure project timelines are met.
  • Estimate time and resource requirements for research initiatives.
  • Supervise the collection, entry, validation, management, analysis, and dissemination of data.
  • Employ statistical software for data analysis and result interpretation.
  • Design and manage databases, data collection tools, error-checking protocols, and related systems for effective data handling and reporting.
  • Resolve moderately complex technical issues.
  • Draft data management and operational documentation for research projects.
  • Act as a liaison between clinical centers and remote research sites and personnel.
  • Conduct structured interviews with study participants.
  • Ensure adherence to established research methodologies and proper handling of research materials in line with protocols, policies, and procedures.
  • Engage in the development of promotional strategies and materials to foster participation and support for research initiatives.
  • Provide consultation on protocol formulation, student organization, and data management tasks.
  • Create presentations and conduct training sessions for project staff and participants.
  • Present findings at meetings, seminars, and conferences.
  • Keep stakeholders informed of project developments through regular updates and newsletters.
  • Manage research project budgets, create financial forecasts, and adjust budgets as necessary throughout the fiscal period.
  • Implement appropriate controls, monitor, and reconcile financial accounts.
  • Conduct literature reviews.

Qualifications:

  • Bachelor's degree in a relevant discipline.
  • A minimum of 5 years of pertinent experience.

Preferred Qualifications:

  • Evidence of research training (e.g., HRM, CCRP/A certification, or equivalent)
  • Experience with grant submissions for peer-reviewed funding opportunities (e.g., CIHR)
  • Familiarity with submissions to Research Ethics Boards
  • Experience in day-to-day clinical trial operations, particularly in regulated environments (Health Canada/FDA) including patient recruitment and study visits
  • Background in developing study documentation such as operational manuals and protocols
  • Coordination experience in multi-center clinical trials is advantageous
  • Preference for candidates with EMR experience (especially Epic and MEDITECH)
  • Strong written and verbal communication skills
  • Excellent organizational abilities and capacity to manage multiple priorities and deadlines, including overseeing several trials simultaneously
  • Detail-oriented individual with initiative, capable of working independently and collaboratively within a team.
  • Strong problem-solving skills
  • Preference for candidates with data management experience, including proficiency in REDCap, development of database dictionaries, and generating reports for data integrity and compliance
  • Knowledge of hematology, bleeding disorders, and transfusion medicine is a plus.

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