POSITION SUMMARY
As a fully integrated Clinical Research Organization (CRO) with deep roots in the academic research and medical worlds, we excel at offering tailor-made services covering any types and phases of clinical trials in the academic, pharmaceutical and biotechnological fields. Our core expertise resides in study project management, data management, site management and biostatistics.
The incumbent in this role based in-house is responsible to perform mostly remote and limited onsite 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.
GENERAL RESPONSIBILITIES:
- Monitor clinical studies remotely and perform limited on site monitoring 0-25% of time 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 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 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 other CRAs if needed with PM and sponsor approval, to perform remote and onsite monitoring.
- 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)
QUALIFICATIONS:
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.
WORKING CONDITIONS:
- 35 hours weekly base;
- Pre-approved overtime paid;
- Flexible work schedule for work-family balance;
- Limited travel time;
- 4 weeks’ vacation after one year;
- 13 statutory holidays;
- Defined retirement benefits;
- Group insurance;
- 9.6 day off sick days;
- Incumbent may be required to work overtime if required ;
- In-house position with limited travel expected (0-25%);
- Flexibility to work from home ;
- Salary based on experience ;
- Other benefits included.
TO SUBMIT YOUR APPLICATION
- Final date to apply : December 31 2018
- By email : dotation@icm-mhi.org
- Your presentation letter and your resume must be combined in one file (Word or PDF) and it must be identified this way : Name_Last name (ex : Hamel_Danny)
- Please indicate the job title for which you’re submitting your application
Visit our Web site : www.mhicc.org
We offer equal employment opportunities to all.
Only candidates that have been met will receive a written answer
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.