Clinical research coordinator - Montréal - ref. o6239619

Company Overview:

Working at Shriners Hospitals for Children - Canada means working in a patient and family centered care environment where there are many opportunities for professional development. You will work in an innovative, creative and multidisciplinary environment focused on improving the quality of life of children and their families.

With its committed and dedicated staff, Shriners Hospitals for Children - Canada has been helping children reach their full potential for over 90 years.

Job Overview:

Work Schedule: 35 hours per week

We are currently seeking to hire a Clinical Research Coordinator to play a key role within our Clinical Research department and Sports Medicine Program. The mission of the Clinical Research Department is to support our researchers in the conduct of research projects aimed at testing new approaches to diagnose, treat and improve the care of our patients and expand the knowledge on the conditions treated at our institution.

Research efforts will be important components in helping to understand trends leading to injury, identify ways to optimize treatment protocols, and ultimately improve standards of care in sports medicine.

The main responsibility of this person will be to work with researchers and study teams to oversee and ensure i) proper study conduct, ii) subject safety, and iii) the quality of data and data safeguards for their assigned clinical research projects in accordance with clinical research regulations and ethics standards, as well as SHC policies procedures.

The skillsets of a natural leader are highly desirable traits that the chosen candidate is expected to demonstrate.

The selected candidate will fall under the direct supervision of the SHC-Canada Clinical Research Coordinator, Dr Michaela Durigova, and will be expected to work closely with the Director of Sports Medicine, Dr Thierry Pauyo, and his team; and collaborate with researchers at the SHC-CAN.

Responsibilities:

• Responsible for coordinating and tracking all aspects of clinical research projects including assessment of study feasibility and protocol development; obtaining study approvals; study set-up (prepare and maintain study and essential documents); participant recruitment; data collection and data entry; budget monitoring (if applicable); study close-out activities.
• Actively collaborate and act as the primary liaison with applicable Shriners headquarters departments, study sponsor(s) for tasks related to protocol reviews, IRB submissions, contracts, study conduct, patient safety and data safeguards.
• Develop and prepare study documents (protocol, informed consent and other study materials) for SHC and IRB approval.
• Independently ensure studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) and Human Subject Protection (HSP) guidelines, applicable regulatory requirements, SHC policies and standards. Maintain and verify study essential documents throughout the study.
• Screen and recruit participants; obtain informed consent; document informed consent process and confirm study participant’s eligibility for research projects.
• Responsible for all elements of the study participant’s visit, including data collection and data entry into study database(s).
• May be involved in performing some study-required assessments and procedures.
• Create and update source documents and all other necessary materials needed to ensure the studies are being performed efficiently and within established timelines.
• Coordinate the collection of data throughout the clinical study including (1) timely data collection, (2) ensuring accurate data entry into secure databases, (3) verifying data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable for source documents, (4) data cleaning and database lock procedures in preparation for data analysis. Verify and monitor study activities to ensure they are conducted according to the approved research plan.
• Oversee assigned study-specific datasets including location of datasets, location of key codes, data access.
• Assist with the review and resolution of any protocol/data compliance issues noted related to assigned studies.
• Involved in data monitoring and preparation of studies for audits/reviews by SHC headquarters, sponsors, regulatory authorities.
• Assist with coordination of regular research meetings to insure proper tracking of progress of the clinical research projects.

Qualifications:

• Bachelor’s Degree in science or other related field or combination of experience and pertinent training- preferred.
• Master’s Degree in discipline relevant to the functions – preferred
• 3 or more years of experience in clinical research e.g. experience with site management, study management (including leading multi-site projects), IRBs and compliance with regulations and standards of clinical research.
• CCRP or CCRC certification - preferred

• Fluency in French written and spoken; capacity to communicate in English is required in order to support or collaborate with English-speaking clients and/or stakeholders.
• Experience in the use of Microsoft Office, including Word, Excel, and Power Point.
• Knowledge of electronic health systems and databases used in research environments.
• Current knowledge of clinical research regulatory requirements.
• Ability to function independently as well as part of an interdisciplinary team and interact with a variety of administrative and professional personnel.
• Ability to be detailed oriented, analytical and possess the ability to ensure resolution and compliance

Interested in working with us? Apply today.