Reporting to the Director of Research & Innovation, the Research Coordinator will work directly with investigators and other stakeholders to ensure quality and effective operations of research and innovation projects, including clinical trials, from study start-up to study completion and archiving. The role includes management of both research and innovation projects throughout the entire project lifecycle, while maintaining ethical and regulatory requirements.
The Research Coordinator will assist with project preparation/activation/submission, comprehend and adhere to study protocols, recruit/screen participants, collect and record data, manage study activities, monitor compliance, report Adverse Events, educate/train and communicate effectively. The Research Coordinator will assist with policy and standard operating procedures development and review, and manage daily operations of projects to ensure protocol are adhered to and following ICH GCP guidelines and any relevant regulations (ex. Health Canada Division 5, TSCP-2, FDA).
Qualifications / Skills / Abilities:
Required
- University Degree in a related field (ex. health science, public health)
- Post graduate diploma or certification in Clinical Research
- Minimum 3 years of experience in healthcare innovation, research project management or related field
- Previous experience working in a clinical research setting and a thorough understanding of regulatory requirements including knowledge of International Conference on Harmonization – Good Clinical Practice (ICH-GCP), N2’s Standard Operating Procedures
- Society of Clinical Research Associate (SOCRA), Certified Clinical Research Professional (CCRP) designation is strongly recommended
- Demonstrated excellence in planning, coordination and execution within tight timeframes
- Demonstrated ability in change management and quality improvement
- Strong collaboration skills including working in a team-work environment, as well as independently
- Strong problem solving skills, multi-tasking and demonstrated people leadership skills
- Excellent written and verbal communication skills
- Must be able to work well with Microsoft Windows, Word and Excel, and has an understanding of research documentation platforms
- Excellent organizational and interpersonal skills, sound judgment, analytical thinking and initiative
- G class Driver’s license and access to a vehicle; travel may be required to all hospital sites
- Recent satisfactory performance and attendance record
- Adherence to Brightshores ‘CARE’ Behaviours (Collaboration, Accountability, Respect, Excellence) and ‘LEAD’ Competencies (Lead by example, Empower, Achieve results, Develop others) and a commitment to a safe workplace free of violence and harassment
- Advocates and supports a culture of patient safety and demonstrates an understanding of how the department service and assigned responsibilities contribute to overall patient safety at Brightshores through patient safety knowledge, skills and attitudes