Pharmaceutical Clinical Research Coordinator – Lipids, Nutrition and Cardiovascular Prevention Clinic

Founded in 1967, the Montreal Clinical Research Institute (IRCM) is a non-profit organization dedicated to fundamental and clinical biomedical research under a wide variety of themes. 

The IRCM clinic is a reference center for care and clinical research. It is affiliated with the University of Montreal Hospital Center (CHUM). She provides innovative and personalized care through a multidisciplinary approach. In addition, many academic and pharmaceutical clinical research projects are underway there, particularly for rare diseases of lipid metabolism.

The IRCM clinic houses a clinic for lipids, nutrition and cardiovascular prevention, including a subspecialty in genetic dyslipidemia. She is currently looking to recruit a clinical research coordinator to join the lipid research team.

Summary of responsibilities: 
The candidate will work under the direction of the principal investigator, Dr. Sophie Bernard, and within the clinical research team in lipids. This person will collaborate in clinical trials sponsored by the pharmaceutical industry.

Primary Duties and Responsibilities: 
•    Coordinate and implement pharmaceutical industry-sponsored clinical trials, from pre-study preparation to closure visits, in accordance with Good Clinical Practice (ICH/GCP) guidelines. 
•    Possess an excellent working knowledge of all assigned protocols, including patient eligibility requirements, achievement of inclusion goals, visit schedule, laboratory assessments and procedures, medication accountability, and maintenance regulatory documents. Facilitate control visits and database cleaning with monitors. 
•    Participate in the informed consent process with research participants, the creation of source documentation if necessary and study-specific documents within specified timeframes as well as electronic data entry and query resolution. Review and file all documents and respond to specific study correspondence and inquiries. 
•    Prepare and submit the relevant documents to the ethics committee at the beginning, during and at the end of the study. 
•    Other responsibilities include recruiting patients, scheduling patient visits, reporting deviations and adverse events as per protocol. They also include the collection of medical and concomitant medication histories by interviewing the patient as well as taking measurements of vital signs.

Training Activities:
•    Keeping skills up to date in accordance with the requirements established by his professional order (if applicable). 
•    Participating in training activities in the field of lipid metabolism.

Qualifications:
•    Bachelor's degree in science / health or equivalent experience
•    Must have a minimum of 2 years of experience in pharmaceutical clinical research and knowledge of the applicable regulations.
•    Bilingualism required (French and English) 
•    Mastery of the usual software (Office suite)
•    Training in good clinical practices (ICH/GCP). 
•    Training as a health professional would be an asset.

Knowledge and Skills:
•    Excellent clinical judgment. 
•    Organizational skills. 
•    Leadership, teamwork, ease of communication, ability to listen. 
•    Ability to manage multiple concurrent priorities 
•    Demonstrate professional rigor, integrity, judgment, flexibility, discretion, and diplomacy. 
•    Knowledge of the preparation of ethical submissions and regulatory documents. 
•    Knowledge of various electronic data capture sites (RAVE, Clario etc) would be an asset. 
•    Knowledge in the field of metabolism would be an asset.

Terms of Employment:
•    Regular part-time daytime position, 3 days/week.
•    Contribution to the Government and Public Employees Retirement Plan (RREGOP).
•    Life, health and salary insurance plans.
•    Employee Assistance Program.
•    Entry into service as soon as possible.

How to Apply :
•    Send your curriculum vitae and cover letter specifying the Competition – Lipids Clinical Research Coordinator to the email address: RecruteRH@ircm.qc.ca

We thank all applicants for their interest, however, only those selected for an interview will be contacted.

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