Job Description

We are seeking a Clinical Research Coordinator who possesses the ability to understand and follow institutional standard operating procedures (SOPs). The ideal candidate will review and assess protocols, including amendments, for clarity and logistical feasibility. This role involves ensuring that all training and study requirements are met prior to the conduct of trials. You will also discuss study medication, required procedures, eligibility criteria, and impact on office flow with investigators and site staff.

ResponsibilitiesAssist with the planning and creation of appropriate recruitment materials.Develop recruitment plans and obtain listings of potential candidates from the subject database.Actively work with the recruitment team in calling and recruiting subjects.Attend Investigator meetings as required.Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.Assist in the creation and review of source documents.Ensure adequate supplies have arrived on site for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access.Prioritize activities with specific regard to protocol timelines.Maintain adherence to Health Canada Division 5 regulations and ICH guidelines in all aspects of conducting clinical trials.Maintain effective relationships with study participants and other personnel.Prescreen study candidates and obtain informed consent per SOP.Complete visit procedures in accordance with protocol.Train others and complete basic clinical procedures, such as blood draws, vital signs, and ECGs.Review laboratory results, ECGs, and other test results for completeness and alert values.Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor.Record data legibly and enter in real time on paper or e-source documents.Accurately record study medication inventory, medication dispensation, and patient compliance.Resolve data management queries and correct source data within sponsor-provided timelines.Assist regulatory personnel with completion and filing of regulatory documents.Perform other duties as assigned.Essential SkillsExcellent working knowledge of medical and research terminology.Strong understanding of federal regulations and good clinical practices (GCP).Ability to communicate and work effectively with a diverse team of professionals.Strong organizational, prioritization, and leadership skills with attention to detail.Strong computer skills, including clinical trials database, IVR systems, electronic data capture, MS Word and Excel.Critical thinking and problem-solving skills.Friendly, outgoing personality with a positive attitude under pressure.High level of self-motivation and energy.Excellent professional writing and communication skills.Ability to work independently in a fast-paced environment with minimal supervision.Additional Skills & QualificationsBachelor’s Degree preferred, or equivalent combination of education, training, and experience.Minimum of 1 year prior Clinical Research Coordinator experience required.Clinical Research coordination experience (2-3 years preferred).Chart review expertise.Work Environment

This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (