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Clinical Research Coordinator I

3 months ago

Halifax, Nova Scotia, Canada Centricity Research Full time

POSITION FUNCTION


The Clinical Research Coordinator I (CRC I) performs a variety of administrative and clinical activities to assist the Investigators in conducting clinical studies.

The CRC I will have a strong understanding of study protocols and will coordinate and manage study activities completely and accurately.


ESSENTIAL FUNCTIONS

Protocol and Safety:

  • Ensure the safety and welfare of study participants
  • Conduct the study as per protocol, GCP, and WPs/SOPs including screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e.g. vitals
  • Be knowledgeable of study protocol to ensure all study activities are completed correctly

Recruiting, Screening, and Enrolling Study Participants:

  • Promote and support study participant recruitment and enrollment initiatives
  • Ensure proper written informed consent from each study participant prior to participation in the study and maintained during the study

Study Visit Completion_:
_

  • Perform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the Investigator
  • Perform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/site
  • Perform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/site
  • Obtain all necessary documentation as required by the protocol
  • Timely and accurate completion of source, data, CRFs, queries and CTMS

Safety Reporting & Data Integrity:

  • Collect and report all adverse events and abnormal results to the Investigator, Sponsor, and REB as per protocol and REB requirements
  • Report Serious Adverse Events and other expedited safety events within 24 hours to the Investigator, Sponsor, and REB and complete appropriate followup as required
  • Accurately dispense investigational product and other study supplies
  • Document receipt, storage, and maintain inventory of investigational product and other study supplies
  • Coordinate and prepare for monitoring visits and audits
  • Perform regular self and peer quality control (QC) checks and other QC tasks as deemed necessary
  • Review source documents and any other research documents required for the successful conduct of the clinical research study
  • Maintain and update all required documentation in the Investigator Site File, as required
  • Complete periodic/annual study reports for REB, as required

General:

  • Abide by GCP, WPs/SOPs, company guidelines, and local healthcare privacy regulations
  • Communicate study questions to the Investigators/Research Management/other CRPs
  • Communicate study updates and learnings with applicable staff
  • Maintain professional relationships with study participants, physicians, industry representatives and vendors of trial management
  • Support and maintain lab supplies, documents, equipment, as required
  • Provide input on quarterly recruitment targets and support efforts to achieve site/company targets
  • Attend site, company, and sponsor meetings and study trainings
  • Participate in oncall schedule, if required
  • Organize and participate in community and company outreach events as required (expectation 12 per calendar year)
  • Archive study and study documents upon completion of a study
  • Assist the Research Management and Investigators with any other research tasks as required
EDUCATION/EXPERIENCE

Minimum:

  • CAN: College/University degree in a relevant field of science
  • US: HS/GED
  • CAN/US: Depending on role requirements, specific degree and licensure from designated provincial/state body the location of the clinical site (ex. RN, MLT, etc.)
  • Active BLS certification (for CPU setting)
  • Proficient IV and phlebotomy skills (as applicable to the site requirements)

Preferred:

  • Experience working in a healthcare environment e.g. blood pressure sphygmometers, automated blood pressure machines, weight scales, and ECG machines
  • Knowledge of medical terminology
  • Phlebotomy experience an asset
  • Active ACLS certification (for CPU setting)
CORE COMPETENCIES/SKILLS

  • Prerequisite (Essential):_
  • Excellent communication skills (verbal and written)
  • Excellent computer skills (MS Word, Excel and Outlook)
  • Attention to detail
  • Ability to manage time efficiently
  • Selfdirected
  • Teamwork & Collaboration
  • Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
  • Flexible & Adaptable
  • Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines
  • Foundation:_
  • Conflict resolution
  • Receptive to feedback
  • Empowering & Developing others
  • Empathy Skills
  • Planning and organizing skills
  • Excellent problemsolving skills
  • Achievement oriented
  • Analytical ability
  • Initiative
  • Decision making
  • Leadership:_
  • Forward thinking
  • Innovative
  • Creative
  • Strategic thinking
  • Self confidence
  • Strong interpersonal skills

PHYSICAL DEMANDS

  • Physical demands include but