Clinical Research Coordinator Iii

5 months 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 protocol, regulatory requirements, policies and SOPs. Additionally, the CRC III will be responsible for overseeing/conducting the training and development of the CRCs and clinical staff as it relates to conduct and management of clinical trial projects and SOPs.

**Primary Responsibilities**:

- Provides leadership and oversees training of clinical research coordinators and research assistants
- Resolves issues related to study protocols and escalates issues as appropriate
- Identifies and implements corrective actions and process improvements
- Leads and coordinates, or co-leads/mentors assigned clinical research projects in accordance with Protocols, SOPs, WIs and applicable regulations, responsible for planning, oversight of study execution, data collection, query resolution and successful closure
- Prepares schedules for CRCs and Research Assistants to ensure appropriate coverage for clinical study requirements
- Liaises with recruitment team, laboratory team, pharmacy team, medical team, Investigators, and QC team to ensure study requirements and timelines are met
- Liaises with Quality Assurance to ensure that all the training requirements are complete and up to date for the CRCs
- Prepares for and participates in regulatory inspections, Sponsor or internal QA audits and monitoring visits
- Provides accurate and timely project status updates to Clinic-In Charge, Management and Sponsors
- Assists Clinic Supervisor with feasibilities when requested
- Ensures regulatory documents for all projects are accurate and completed in a timely manner for Sponsors/Sponsor representatives during start up through close-out
- 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
- Attends Investigator Meetings for projects assigned
- Accommodates flexible schedule (available days, afternoons, nights, and weekends)
- Minimal travel may be required for Investigator meetings and training (up to 25%)
- Any ad hoc duties as assigned by the Qualified Investigator/Sub-Investigator, Clinic Supervisor and/or Management
- Other duties as may be required by training and experience allow
- Promotes GXP compliance across the organization
- Maintains an attitude and philosophy consistent with the Company’s standards

**Core Competencies**
- Thorough knowledge of the methodology related to the conduct and monitoring of clinical trials per ICH E6 guidelines and per Part C, Division 5 of the Health Canada Food and Drug regulations
- Understanding of Natural Health Product regulations, Cannabis regulations is an asset
- Ability to develop, manage and forecast budgets, timelines, and resources
- Ability to manage multiple projects/assignments at a time with the ability to prioritize deliverables
- Strong leadership skills and demonstrates sound judgement
- Strong verbal and written communication skills in English (spoken and written)
- Excellent organizational and time management skills required
- Strong analytical and problem solving skills
- Excellent interpersonal, verbal and written communication skills required

**Education, Experience and Training**
- BSc in health, science or related field
- 6+ years experience in a CRC role, with a minimum of 3 years leading clinical studies, preferably in a fast-paced pharmaceutical clinical research unit
- Experience with clinical research software such as CTMS (e.g. RealTime) and EDC (Medrio, Rave, etc.)
- Experience with Controlled Substances is an asset
- Preference will be given to certified clinical research coordinators
- Pediatric and Geriatric research experience is an asset

**Benefits**:

- Dental care
- Extended health care
- Paid time off

Schedule:

- Monday to Friday
- Weekends as needed

Work Location: In person

  • Research Assistant Technician Iii

    2 months ago

    Guelph, Canada University of Guelph Full time

    **Department**:Clinical Studies This position is classified under the Grant and Trust Administrative & Technical Group Temporary full-time from 09/22/2024 to 09/21/2026 **General Purpose** Reporting to a faculty member in the department of Clinical Studies, the department is seeking to hire a temporary part time Research Assistant/Technician III to assist...

  • Clinical Research Coordinator

    5 months 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...

  • Clinical Research Coordinator Ii

    2 weeks ago

    Guelph, Canada Nutrasource Full time

    **Job Overview**: Nutrasource is seeking **Clinical Research Coordinator 2** (CRC 2) is responsible for assisting with and leading research study activities, assisting in project planning and set-up, and ensuring that the site staff follow specific requirements of the protocol, regulatory requirements, policies, Standard Operating Procedures (SOPs) and Work...

  • Clinical Research Associate

    3 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly skilled Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC. As a Clinical Research Associate, you will be responsible for conducting clinical or laboratory studies to test, evaluate, and screen drugs, pharmaceuticals, and nanoparticles used in...

  • Clinical Research Associate

    3 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly skilled Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC. As a Clinical Research Associate, you will be responsible for conducting clinical or laboratory studies to test, evaluate, and screen drugs, pharmaceuticals, and nanoparticles used in...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job SummaryThe Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job SummaryThe Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    3 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    3 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    3 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    1 month ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly skilled Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC. As a Clinical Research Associate, you will play a critical role in the commercialization of new products and the conduct of clinical or laboratory studies to test, evaluate, and...

  • Clinical Research Associate

    1 month ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly skilled Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC. As a Clinical Research Associate, you will play a critical role in the commercialization of new products and the conduct of clinical or laboratory studies to test, evaluate, and...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and updating health information databases, participating in the commercialization of...

  • Clinical Research Associate

    4 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and updating health information databases, participating in the commercialization of...

  • Clinical Research Associate

    3 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...

  • Clinical Research Associate

    3 weeks ago

    Guelph, Ontario, Canada Nutrasource Pharmaceutical and Nutraceutical Services INC Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at Nutrasource Pharmaceutical and Nutraceutical Services INC.Job Summary:The Clinical Research Associate will be responsible for managing and maintaining health information databases, participating in the commercialization...