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Full job description

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. Preference will be given to candidates with prior experience leading pharmaceutical clinical trials, and those with a medical background (e.g. foreign trained MDs, paramedics, nurses).

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
• Understands care of study participants, aspects of human subject protection and safety

· 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

Job Type: Full-time

Benefits:

• Dental care
• Extended health care
• Paid time off

Schedule:

• Monday to Friday
• Weekends as needed

Work Location: In person