Company Overview:

Shriners Hospitals for Children - Canada provides ultra-specialized short-term orthopedic care to children in Quebec, other Canadian provinces, the United States and around the world. Affiliated with the Réseau universitaire intégré de santé et service sociaux McGill (RUISSS), the hospital promotes excellence and innovation in care, teaching and research. 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:

Status: Temporary, full-time position, minimum 12-month maternity leave replacement.
Work Schedule: 35 hours per week

We are currently seeking to hire a Clinical Research Coordinator – Level 1 to play a key support role within the Clinical Research department. The mission of the Clinical Research Department is to support our researchers in the conduct of innovative research projects aimed at testing new approaches to diagnose, treat and improve the care of our patients. The selected candidate will work with researchers and study teams to help ensure proper study conduct, subject safety, and 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. This person will fall under the supervision of the SHC-Canada Clinical Research Department Coordinator- Dr Michaela Durigova, will be expected to work closely with principal investigator Dr Dahan-Oliel, and the research team working on the Arthrogryposis research program.

Responsibilities:

• Responsible for tracking assigned projects including all study, investigator and Institutional Review Board (IRB) information, and patient recruitment activity.

• Actively collaborate with Research Programs at SHC Headquarters with regards to protocol reviews, IRB submissions, study conduct, patient safety and data safeguards.

• Prepare study documents (protocol, informed consent forms and other study materials) for SHC and IRB submission and approval.

• Maintain and verify study essential documents throughout the study.

• Ensure and monitor study activities are conducted according to the SHC and IRB-approved research plan.

• Assist with direction and education of research staff on protocol-related activities, patient safety and data safeguards

• Recruit patients, obtain informed consent, document informed consent process and confirm study participant’s eligibility for research studies.

• Responsible for all elements of the study participants’ visit, including data collection.

• May be involved in performing some of the study-required assessments and procedures.

• Handle and ship samples from study participants for genomic analysis to SHC’s Genomic Institute in Tampa and maintain shipping logs.

• Create and update source documents and all other necessary information needed to ensure the studies are being performed efficiently and within established timelines.

• Coordinate the collection of data and data entry 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.

• Oversee assigned study specific datasets including location of datasets, location of key codes, data access.

• Contribute in compiling and preparing study data for analysis (e.g., data cleaning).

• Assist with the review and resolution of any protocol/data compliance issues noted related to assigned studies, e.g. root cause discovery, re-training of staff, etc.

• Coordinate multi-site studies and ensure communications with CRCs from other participating sites.

• Act as the primary liaison for study participants, study team, IRB, sponsor, Research Programs at SHC Headquarters, other participating sites (if applicable) for all questions regarding assigned studies.

Qualifications:

• Bachelors in science or other healthcare related field – preferred
• CCRP or CCRC certification-preferred
• 1 -2 years of experience (or more) in clinical research– required.
• Certificates of training on Good Clinical Practice and Ethics of Research with Human Participants (TCPS2)- preferred
• Experience coordinating multi-site research projects and managing participating site- preferred

Key Competencies

• 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.
• Knowledge of clinical research procedures, regulations, protocols, IRB submission processes.
• Ability to function independently as well as part of an interdisciplinary team and interact with a variety of administrative and professional personnel using initiative and good judgement;
• Ability to be detailed oriented, analytical and possess the ability to ensure resolution and compliance.
• Experience in the use of Microsoft Office, including Word, Excel and Power Point.