Clinical Research Coordinator
6 days ago
**Responsibilities for this position may include, but are not limited to**:
- Patient recruitment and follow-up, data collection, and data entry.
- Overseeing study start-up activities (approvals, contract, regulatory submissions including Clinical Trial Applications with Health Canada, training) internally for investigator-initiated trials.
- Maintaining current up-to-date regulatory binder/files.
- Facilitating physician oversight over study participants following GCP requirements.
- Safety reporting, data management, site communications, budget and financial tracking/reconciliation, scheduling and preparing reports for the Steering Committee, Adjudication Committee and Data Safety Monitoring Board meetings, etc.
- Conduct remote site visits to ensure compliance with study protocols, GCP, and regulatory requirements, including source data verification (SDV) and essential document review.
- Identify and resolve data discrepancies, protocol deviations, and compliance risks by working closely with site staff, investigators, and the study team to maintain data integrity and study quality.
- Ensure adherence to recognized guidelines and standards of clinical practice by all research staff with regards to patient recruitment, care, follow up and data management.
**Basic Requirements (Education/Experience)**:
- Postsecondary degree or diploma.
- Three (3) years’ experience coordinating clinical trials.
- A comprehensive understanding of the clinical research process from study start-up to completion.
- Experience coordinating investigator-initiated multi-center research trials.
- Evidence of training certification in Tri-Council Policy Statement -2 (TCPS-2) and the International Council on Harmonisation - Good Clinical Practice Guidelines (ICH-GCP).
- Evidence of training in Food and Drug Regulations, Division 5, is required.
- Superior organizational, analytical and time management skills.
- Ability to work independently and as a team member.
- Strong communication skills and bedside manner.
- Strong computer skills: MS Word, PowerPoint, Outlook, Excel, EPIC, and REDCap.
- Ability to set priorities and work independently with accuracy in a dynamic environment.
- Flexibility to accommodate periodically demanding deadlines.
**Preferred Qualifications**:
- Certified Clinical Research Professional is an asset (ACRP OR SOCRA)
- Bilingual in English and French is an asset
**Compensation Pay Range**:
**Salary**: Min: $33.342/hr - Max: $44.456/hr
**Comments to Applicant**:
Please provide your CV and a cover letter to clearly demonstrate how you meet the requirements of the position listed:
**Contact Info**:
Name: Amanda Pecarskie
Title: Sr. Clinical Research Program Manager
Program: Ottawa Blood Disease Center
Ottawa Hospital Research Institute
Address: 501 Smyth Road, CPCR2 - Box 180
- The Ottawa Hospital Research Institute is committed to building and sustaining a welcoming and supportive culture that promotes equity, diversity and inclusion for trainees, researchers, and staff. We are devoted to identifying and removing barriers that limit equitable access to opportunities within our organization. The Ottawa Hospital Research Institute strongly supports initiatives that encourage the participation of all groups, in particular the four groups defined in the Employment Equity Act (women, Indigenous peoples, persons with disabilities and members of visible minorities)._
- We thank all applicants for their interest. However, only those invited for an interview will be contacted. The Ottawa Hospital Research Institute is an equal-opportunity employer. Upon request, accommodations due to a disability are available throughout the selection process._
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