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Associate Specialist H/F - Québec, QC, Canada - Fopconsultants
Description
Brief description of the position :In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for clinical research specialist/associate consultants motivated to carry out mandates.
The main missions would be to remotely or on-site monitor the smooth running of clinical studies and verify that they are documented in accordance with operational procedures and applicable regulatory requirements.
Main responsibilities:
Without limitation, the main tasks involve:
Coordinate remote and on-site monitoring of clinical study sites;
Perform all necessary checks on source data, adverse events, compliance of reports, investigator files, sample storage locations and conditions, and all other activities provided for in the monitoring plan;
Ensure that on-site clinical study activities are carried out in accordance with protocols, SOPs, GCPs and other applicable regulations;
Collaborate and provide support to site personnel in order to answer questions and solve problems;
Identify the improvements to be made on the on-site studies and report the analyzes to the monitoring manager;
Check the recording of serious adverse reactions in accordance with the specifications of the tests and ICH standards;
Write monitoring visit reports and list all relevant observations;
Provide support during on-site audits;
Participate in the development of on-site patient recruitment strategies;
Participate in weekly or monthly meetings on clinical research files.
Qualifications:
~ Bachelor's or master's degree in the clinical field, in science (chemistry, biochemistry, biology, pharmaceuticals, pharmacovigilance, etc.), or any other related discipline;
~1 (one) to 5 (five) years of experience in industry, in the (bio)pharmaceutical sector, in CROs;
~ Experience in a similar position in clinical research;
~ Experience in on-site or remote monitoring visit;
~ Good knowledge of ICH/GCP standards;
~ Knowledge of regulations (Health Canada, FDA);
~ Proficient in MS Office;
~ Good communication and writing skills in French and English;
~ Mobility (an asset).
Personal skills:
~ Leadership;
~ Rigor et discipline;
~(Organize), able to manage several projects;
~ Analytical and critical mindset;
~ Perseverance;
~ Humility.
What we offer :
In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate.
The main advantages offered are as follows:
Competitive wages;
Group insurance;
Professional insurance;
Remote work, according to the customer needs;
Vacations: 3 weeks;
Paid sick leave: 3 days;
Monthly transportation fees;
Career advancement opportunity;
Continuing education.
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