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

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