Clinical Research Coordinator (Brightshores Research Institute)

Full time, Contract, 1.0 FTE (on-site)

POSITION PURPOSE

Brightshores Research Institute is seeking a Clinical Research Coordinator to facilitate implementation of clinical trial research protocols. Reporting to the Manager of Research & Innovation, the Clinical Research Coordinator will maintain ethical and regulatory requirements while interacting with investigators and other stakeholders to ensure effective study operations. Project coordination will span the life-cycle of studies, from start-up to completion. The Clinical Research Coordinator will assist with study preparation and activation tasks, and must comprehend and adhere to study protocols. Tasks will include participant recruitment and screening, data collection, reporting and adherence to any relevant regulations such as Health Canada Division 5, TSCP-2, FDA, and ICH-GCP guidelines. This is a contract position for 1 year, with opportunity for extension.

MAJOR RESPONSIBILITIES

• Assists Primary Investigators (PI) in the initiation and implementation of study protocols. Works closely with the investigator(s) during screening and follow-up visits.
• Ensures the site is compliant in conducting clinical trial related activities.
• Assists with the recruitment, screening, and the enrolment of potential study participants, including obtaining informed consent.
• Schedules participant and stakeholder visits.
• Follows study related procedures and activities as well as maintains proper source documentation.
• Obtains prescriptions for investigational product IP from the physician and delivers it to the research pharmacist in time for upcoming study visits.
• Provides patient education and counseling regarding protocol requirements, study treatment schedules, the use of data collection tools and follow-up visits.
• Ensures that study patients are efficiently monitored and that safety requirements are implemented as necessary; accurately and promptly reports Serious Adverse Events as dictated by the protocol.
• Arranges and provides compensation and expense reimbursements for participants when applicable.
• Participates in study-related meetings such as site evaluations, site initiations, close-out visits, investigator meetings, monitoring-visits, and study-conference calls.
• Adheres to Standard Operating Procedures (SOPs), and any relevant regulations such as Health Canada Division 5, TSCP-2, FDA, and ICH-GCP guidelines
• Follows ethical procedures as outlined by Research Ethics Board
• Performs data entry and query response.
• Prepares Research Ethics Board submissions including annual renewals and amendments, informed consents.
• Maintains project files (i.e., regulatory binders) and site-specific documents.
• Develops and maintain study-specific tracking, including financial tracking
• Interacts and coordinates with various departments and stakeholders to facilitate study-related activities and study visits.
• Performs study-related assessments as required per protocol and ensures that all documentation is accurate and ongoing.
• Monitors and maintain equipment calibration with vendors when required.
• Manages ongoing mandatory certification for study team members (ex. GCP, Division 5) and collects any required certifications and curriculum vitae
• Undertakes other duties with the research program as required.

QUALIFICATIONS

Required:

• Bachelor Degree in a related field (ex. health science or science)
• Post graduate diploma or certification in Clinical Research an asset
• 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 an asset
• 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 interpersonal 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

HOW TO APPLY:

Please submit your resume and a cover letter outlining your qualifications, interest, and alignment with Brightshores Research Institute’s mission to research@brightshores.ca. Applications will be reviewed on a rolling basis until the position is filled.