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Temporary Full Time position
Montreal Health Innovations Coordinator Center
The incumbent in this role based in-house is responsible to perform remote monitoring to ensure that clinical studies are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice, ICH Guidelines and other applicable regulatory requirements.
This position interacts with site investigators, study coordinators, other clinical personnel, project managers, and sponsor representatives.
• Monitor clinical studies remotely for compliance with protocol/amendments, monitoring plan, SOPs, GCP, ICH Guidelines and other applicable regulatory requirements
• Ensure that the rights and well-being of human subjects are protected
• Perform remote monitoring including pre-study evaluations, study initiation training, interim monitoring and study closeout activities
• Review selected clinical study source documentation (if available) and data in other databases or systems for accuracy, completeness, compliance and consistency with clinical database
• Document remote monitoring in a monitoring report; follow-up and review site corrective actions to ensure effective resolution
• Submit monitoring reports to the MHICC Project Manager
• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
• Ensure effective communication with the site, sponsor and MHICC Project Manager; ensure critical observations are immediately communicated to the site, sponsor, MHICC Project Manager and effective resolution is obtained
• Coordinate, collaborate, and train onsite CRA if needed with PM and sponsor approval, to perform onsite monitoring and/or perform limited onsite monitoring (0-10% of time) as needed
• Serve as the first line of contact for study coordinators, investigators, and other site staff regarding investigational product and protocol questions
• Assist the sites in the preparation of sponsor or MHICC audits and regulatory inspections
• Participate in MHICC and sponsor required training programs
• Perform necessary administrative functions (e.g. tracking of time on studies)
This position has no supervisory responsibilities
Education: Bachelor’s degree in health sciences or nursing. College nursing diploma and/or DESS in Clinical Research is preferred.
Experience: A minimum of five (5) years clinical research monitoring, clinical study coordination of industry-sponsored studies, or clinical research project management (with oversight of monitoring activities) experience. Cardiovascular therapeutic area and risk-based monitoring knowledge is an asset.
Skills: Excellent organizational, time management and problem solving skills. The ability to work with study teams and independently with minimal supervision. Excellent interpersonal and communication skills and detailed-oriented. Must have French and English verbal and written communication abilities.
Knowledge: Good knowledge of clinical studies monitoring, Good Clinical Practice, ICH Guidelines and clinical research methodology. Computer literacy, proficiency in MS Office (MS Word, Excel, Powerpoint). InForm 6.0 and MS Project proficiency is an asset.
• Incumbent may be required to work overtime if required
• In-house position with limited or no travel expected (0-10%)
This job description is not created to imply that these requirements are the only duties, responsibilities and qualifications for the job. Incumbents may be required to follow any additional related instructions, acquire related job skills and perform other related work, as required.
We invite you to apply directly on our web site before January 30th 2017 by sending us your resume at firstname.lastname@example.org
Consult our web sites: www.icm-mhi.org and www.mhicc.org
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