Job Description
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 follow-up 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 on-call schedule, if required
- Timely phone and email communication
- Organize and participate in community and company outreach events as required (expectation 1-2 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
Job Tags
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