The Moncton Hospital (Horizon Health Network), Division of Infectious Diseases Clinical Research Coordinator Contract in Moncton, NB

The Moncton Hospital (Horizon Health Network), Division of Infectious Diseases

Branch Moncton NB CA

Clinical Research Coordinator
Moncton, NB

Grant writing, Study design, Collection of data, Statistical analysis and Manuscript preparation. Participates in preparation of grants and manuscripts, as well…

Job Purpose:
Reporting to the Principal Investigator, the Research Coordinator is responsible for the coordination of research projects conducted within the Department of Medicine, Division of Infectious Diseases. This includes the administration of the study, the screening, care and treatment of research participants and the collection of research data in accordance with the established study protocol, applicable Health Canada Food and Drug regulations and FDA regulations for clinical trials.
This is a contract position with full-time hours.

Essential Qualifications:

  • Advanced academic qualifications preferred (MSc or PhD) or Bachelor’s Degree in a health-related field with extensive experience in coordination role. Applicants not meeting the above criteria will not be considered.
  • Minimum of two (2) years of clinical research experience required, preferable in infectious diseases.
  • Formal training in Clinical Research or Clinical Research Certification (ACRP or SOCRA) an asset.
  • Experience with Randomized, Controlled Clinical Trials
  • Knowledge of the principles and procedures of clinical research
  • Knowledge of Health Canada and FDA Regulations, ICH-GCP Guidelines and other legislation/standards pertaining to research
  • Experience in REB application submissions, Clinical Trial Ethics documentation and SAE reporting
  • Knowledge of specimen processing guidelines
  • Experience in budget development and management
  • Ability to manage multiple projects and initiatives
  • Experience with patient recruitment and data collection and Ability to recruit, evaluate, and instruct clinical research participants
  • Ability to design and implement systems necessary in the collection, maintenance and analysis of data
  • Demonstrated expertise and ability to apply, teach and mentor staff in: Grant writing, Study design, Collection of data, Statistical analysis and Manuscript preparation
  • Sound knowledge of various granting agencies and funding opportunities as well as grant application process
  • Ability to work in a changing, multiple-demand setting, to prioritize a large volume of work, and to meet deadlines efficiently
  • Effective interpersonal, communication (written and verbal), organizational and time management skills
  • Ability to work independently and demonstrated experience in working within a multidisciplinary team and/or framework
  • Proficiency in use of data bases, clinical trials software, statistical software packages and Microsoft Office suites.
  • Facilitation and presentation skills
  • High regard for confidentiality
  • Ability to attend work on a regular basis
  • Ability to perform the duties of the position
  • Good work record
  • Written and spoken competence in English is required

Key Responsibilities:

  • Plans, schedules and implements daily research activities and procedures
  • Participates in preparation of grants and manuscripts, as well as study design
  • Coordinates and ensures proper execution of all aspects of the study visits, including diagnostic/clinical tests, assessments and appointments
  • Screens potential clinical research participants by reviewing hospital admissions, laboratory data and infection control records
  • Educates and counsels research participants on treatment methods and study protocol
  • Provides adequate care and treatment to research participants
  • Obtains informed consent from research participants, as delegated by the Principal Investigator
  • Performs appropriate designated procedures and obtains necessary samples according to clinical trial/study protocol
  • Provides regular updates and reminders to relevant physician/nursing groups regarding study procedures
  • Works with the Hospital departments, Emergency Room staff and hospital administration to develop systematic means of recruiting study subjects and performing appropriate study procedures
  • Communicates study progress to Sponsor and Principal Investigator
  • Monitors research participants for all Adverse Events and Serious Adverse Events and reports these to the PI, Sponsor, REB and all applicable regulatory authorities
  • Completes case report forms and other relevant data collection tools, as required by the protocol
  • Coordinates all aspects of data collection from source documents
  • Participates in data analysis, preparation of study reports and presentation of results
  • Coordinates and maintains research ethics board submission and documents
  • Assists sponsor representatives (monitors) during visits. Ensures that all study documentation is organized and available for their review
  • Manages study budget and sponsor invoicing
  • Archives study-related documentation and develops a tracking tool for document retrieval from storage

Job Type: Contract

Required education:

  • Bachelor’s

Required experience:

  • Clinical Research: 2 years

or proceed with Standard Application Form.

Employment Type: Freelance
Location: Moncton, NB, CA
Posted on: 2016-11-01
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