Clinical Research Coordinator

4 weeks ago

Guelph, Canada Nutrasource Full time

**Job Overview**:
The **Clinical Research Coordinator 1** (CRC 1) is responsible for research study activities such as assisting in study planning and set-up. They will be required to follow specific requirements of study protocols, regulatory requirements, policies, Standard Operating Procedures (SOPs) and Work Instructions (WI). The CRC 1 will also be required to recruit and coordinate research participants, as appropriate.

**Primary Responsibilities**:

- Coordinates or co-leads assigned clinical research projects in accordance with Protocols, SOPs, WIs, and applicable regulations
- Coordinates or co-leads BA and BE studies and assists with coordination of Phase 1 studies, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies and all phases of the studies as assigned
- Acts as co-Lead CRC on studies, including planning and preparing for studies as follows:

- Assists in review of assigned protocols and other protocol documentation (ICF, IB, electronic Case Report Forms (CRFs), Study Specific Procedures, Study Laboratory manual) for accuracy, feasibility, timing, and resources
- Assists the Recruitment team in pre-screening activities and recruitment of study participants
- Assists in the preparation and maintenance of the Investigator Site File (ISF) for the study
- Participates in study start-up meetings (Investigator Meetings, Site Initiation Visits, Sponsor discussions, or other related meetings)
- Assists in all required start-up activities including, but not limited to, the following:

- Clinic logistics planning, schedule of clinic activities, and team training
- Preparing clinic source collection documents, time and events tables, and other required study materials
- Reviewing CRFs, laboratory workbooks, staff requirements, and schedules
- In collaboration with the responsible teams, establishing and/or maintaining safety assessment requirements, Quality Control (QC) review, pharmacy/ dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study
- Confirmation that all required regulatory and contractual documentation is present prior to study start
- Planning and collaboration with vendors (safety laboratory, bioanalytic lab) for study set-up
- Assists in monitoring budget allocation during the study and escalates as needed to the study lead
- Performs the following during the conduct of a clinical trial:

- Coordinates screening activities and provides support as required
- Coordinates and ensures set-up of clinic rooms, participant chart review, and source document preparation prior to start of clinic activities
- Assists and/or coordinates overall clinic activities including, but not limited to:

- Assist in supervising clinic visits (admission, assist in dosing and randomization, discharge, and follow-up) as required.
- Ensures volunteer eligibility prior to randomization.
- Assists with and performs drug administration and other activities as delegated and required
- In collaboration with the responsible teams, ensures that all study-related activities are conducted according to protocol, SOPs, WIs, and applicable regulations
- Manages clinic updates, Adverse Event (AE) or Serious Adverse Event (SAE) reporting, study logs and trackers, quality control, and monitor findings
- Assists with maintenance and updates to the Investigator Site File (ISF) accordingly
- Escalates observations to Lead CRCs and Investigators as appropriate
- Performs the following after the in-participant phase of the clinical study and in preparation for site close-out:

- Ensures resolution and/or addresses QC, monitor, or other internal/external findings
- Assists in close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation
- Assists in updates of ISF documentation
- Assists in finalizing the study and/or participant logs
- Ensures completion of other close-out activities as required (return of study supplies, REB reports, archiving, etc.)
- Assists in the submission of participant reimbursement requests at the conclusion of their participation in the study
- Monitors participants’ compliance throughout the study
- Addresses day-to-day participant or study issues and escalates as appropriate
- Prepares for regulatory inspections, sponsor or internal QA audits and monitoring visits
- Provides accurate and timely project status updates to Lead CRCs
- Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals
- Accommodates flexible schedules (available days, afternoons, nights, and weekends)
- Minimal travel may be required (up to 25%)
- Any ad hoc duties as assigned by Lead CRCs and Investigators
- Other duties as may be required and as training and experience allow
- Promotes GXP compliance across the organization
- Maintains an attitude and philosophy cons

  • Clinical Research Coordinator

    5 days ago

    Guelph, Ontario, Canada Nutrasource Full time

    Job Overview:The Clinical Research Coordinator 1 (CRC 1) is responsible for research study activities such as assisting in study planning and set-up. They will be required to follow specific requirements of study protocols, regulatory requirements, policies, Standard Operating Procedures (SOPs) and Work Instructions (WI). The CRC 1 will also be required to...

  • Clinical Research Coordinator Iii

    1 week ago

    Guelph, Canada Nutrasource Full time

    Apex Trials by Nutrasource is looking to hire a Clinical Research Coordinator III, with 6+ years pharmaceutical clinical research experience. The Clinical Research Coordinator (CRC) III is responsible for overseeing all research study activities, assisting in project planning and set-up, and ensuring that the site staff follow specific requirements of the...

  • Clinical Research Coordinator

    2 months ago

    Guelph, Canada Nutrasource Full time

    **Position Overview** **Primary Responsibilities**: Conduct the clinical research studies according to the study protocol, ICH GCPs, and SOPs. Be knowledgeable of the protocol so that all study activities are completed correctly. Obtain written informed consent from each study participant prior to participation in the study. Screen the potential study...

  • Clinic Coordinator

    3 weeks ago

    Guelph, Canada Guelph CHC Full time

    PROGRAM AREA: Primary Health EMPLOYMENT STATUS: Full Time Regular, Ongoing HOURS/WEEK: 35 hours per week Our Vision A community without barriers to health and wellbeing Our Mission We reduce health inequities by providing inter-professional primary health services and community programs, focused on our priority populations, in collaboration with...

  • Administrative Coordinator

    4 weeks ago

    Guelph, Canada Homewood Research Institute Full time

    **Administrative Coordinator** **Job Type**: Permanent Part-time (.5 FTE) **Location**: Hybrid position working in Guelph, ON (Canada) and remote/at home **Hiring Range**: $29.07 - $36.34/hour **Posting**: HRI23 - 008 **Posting Date**:Until filled **Potential Start Date**: April 2023 **About HRI** Homewood Research Institute (HRI)is an independent...

  • Clinical Extern Coordinator

    2 weeks ago

    Guelph, Canada Guelph General Hospital (GGH) Full time

    Employment Status Temporary Full-time Department Professional Practice Job Code 7581 At Guelph General Hospital, we are committed to our Mission of _Exemplary and equitable care for and with our community. _ Living our values is important here and if you want to join a team that is compassionate, inclusive, respectful, collaborative and inspired, you...

  • Clinical Trial Recruiter

    2 months ago

    Guelph, Canada Nutrasource Full time

    **Position Overview** The clinical trials recruiter will also be responsible for entering basic information into secure electronic medical record software in compliance with federal and provincial privacy laws. **Primary Responsibilities** Prepare recruitment strategy plans and contingency plans to ensure recruitment goals for studies are met within...

  • Clinical Psychologist

    4 days ago

    Guelph, Ontario, Canada Hamilton Health Sciences Full time

    Unit SummaryStep into a job that opens countless doors. As one of Canada's largest and most diverse hospitals, we're providing advanced care to people of all ages from across the province. You can explore advancement opportunities, take professional development courses, and stretch yourself as a leader, all at HHS. We are the largest employer in the greater...

  • Clinical Trial Assistant

    2 months ago

    Guelph, Canada Nutrasource Full time

    **Job description** **Position Overview** Our rapidly expanding team is looking for a **Clinical Trial Assistant (CTA) **/ **Trial Master File Administrator** who can work for us on a full time basis, supporting our clinic located in Guelph. The role is on site in Guelph ON. The Clinical Trial Associate provides support to one or more cross functional...

  • Clinical Trial Assistant

    2 weeks ago

    Guelph, Canada Nutrasource Full time

    **Job description** **Position Overview** Our rapidly expanding team is looking for a **Clinical Trial Assistant (CTA) **/ **Trial Master File Administrator** who can work for us on a full time basis, supporting our clinic located in Guelph. The role is on site in Guelph ON. The Clinical Trial Associate provides support to one or more cross functional...

  • Clinical Trial Participant Recruiter

    2 months ago

    Guelph, Canada Nutrasource Full time

    **Position Overview** The clinical trials recruiter will also be responsible for entering basic information into secure electronic medical record software in compliance with federal and provincial privacy laws. **Primary Responsibilities** Prepare recruitment strategy plans and contingency plans to ensure recruitment goals for studies are met within...

  • Clinical Coordinator

    4 days ago

    Guelph, Ontario, Canada Canadian Mental Health Association Waterloo Wellington Full time

    Posting Closes: February 7, 2024 at 5:00pmAbout Us:The Canadian Mental Health Association Waterloo Wellington (CMHA WW) provides a full care system for those with addictions, mental health or developmental needs. We serve everyone from children to adults to seniors, all under one roof. Our programs help individuals and families to lead lives filled with...

  • Clinical Coordinator

    5 days ago

    Guelph, Ontario, Canada Canadian Mental Health Association Waterloo Wellington Full time

    Posting Closes: March 27, 2024 at 5:00pmAbout Us:The Canadian Mental Health Association Waterloo Wellington (CMHA WW) provides a full care system for those with addictions, mental health or developmental needs. We serve everyone from children to adults to seniors, all under one roof. Our programs help individuals and families to lead lives filled with...

  • Clinical Education Supervisor

    2 months ago

    Guelph, Canada CB Canada Full time

    Job Number: J0922-1232 Job Title: Clinical Education Supervisor Job Type: Perm F/T City, Province, Country: Guelph, Ontario, Canada Job Category: Nursing Open Positions: 1 Make a difference in a growing, innovative mental health organization and centre of excellence in people-centered care. Work with supportive colleagues who are passionate about...

  • Clinical Education Supervisor

    3 weeks ago

    Guelph, Canada CB Canada Full time

    Job Number: J0922-1232 Job Title: Clinical Education Supervisor Job Type: Perm F/T City, Province, Country: Guelph, Ontario, Canada Job Category: Nursing Open Positions: 1 Make a difference in a growing, innovative mental health organization and centre of excellence in people-centered care. Work with supportive colleagues who are passionate about...

  • Clinical Psychologist

    2 weeks ago

    Guelph, Canada Hamilton Health Sciences Full time

    **Unit Summary** Step into a job that opens countless doors. As one of Canada’s largest and most diverse hospitals, we’re providing advanced care to people of all ages from across the province. You can explore advancement opportunities, take professional development courses, and stretch yourself as a leader, all at HHS. We are the largest employer in...

  • Clinical Education Supervisor

    4 days ago

    Guelph, Ontario, Canada CB Canada Full time

    Job Number:JJob Title:Clinical Education Supervisor Job Type:Perm F/T City, Province, Country:Guelph, Ontario, Canada Job Category:Nursing Open Positions: 1 Make a difference in a growing, innovative mental health organization and centre of excellence in people-centered care. Work with supportive colleagues who are passionate about improving lives and...

  • Research Program Coordinator #2023-0128 Office of

    3 weeks ago

    Guelph, Canada University of Guelph Full time

    **Forbes includes U of G Among Canada’s Best Employers** **Office, Clerical and Technical** **Position covered by the Collective Agreement with USW Local 4120** **Research Program Coordinator**: **Office of Research, Agri-Food Partnership**: **Two (2) positions** **One Regular full-time** **One Temporary full-time from March 2023 to February 29,...

  • Clinical Psychologist

    4 weeks ago

    Guelph, Canada Hamilton Health Sciences Full time €60 - €76

    Unit Summary Step into a job that opens countless doors. As one of Canada's largest and most diverse hospitals, we're providing advanced care to people of all ages from across the province. You can explore advancement opportunities, take professional development courses, and stretch yourself as a leader, all at HHS. We are the largest employer in the greater...

  • Clinical Coordinator

    3 weeks ago

    Guelph, Canada Canadian Mental Health Association Waterloo Wellington Full time

    Posting Closes: March 27, 2024 at 5:00pm About Us: **The Canadian Mental Health Association** Waterloo Wellington (CMHA WW) provides a full care system for those with addictions, mental health or developmental needs. We serve everyone from children to adults to seniors, all under one roof. Our programs help individuals and families to lead lives filled with...