Clinical Research Coordinator

2 weeks ago

Montréal, Canada Centre universitaire de santé McGill Full time

Organization description

Le Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l’échelle internationale pour l’excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d’assurer aux patients des soins fondés sur les connaissances les plus avancées dans le domaine de la santé et de contribuer au progrès des connaissances.
**Job Description**:
RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position summary
The MUHC Pediatric Hematology/Oncology Research Program aims to promote and improve the health of children and young adults diagnosed with cancer or hematological disorders. We support and conduct research and research training in health and illness with the goal of facilitating the development and implementation of clinical trials, biobanks, cancer control, and nurse-initiated studies and protocols. Ongoing efforts to strengthen the interdisciplinary aspects of research are a priority for us.

The purpose of this job is to initiate and coordinate clinical trials according to regulatory and institutional guidelines and requirements, register eligible participants, manage the studies, extract, compile and submit data, monitor study compliance, monitor and maintain ongoing regulatory requirements, and provide information and feedback on designated clinical trial studies.

The clinical research portfolio for this position includes cancer biology studies, personalized cancer treatment studies, and neuroblastoma tumor studies. The clinical trials under this portfolio are from Phases I to III.

General Duties
- Facilitate scientific review of peer-reviewed clinical trials (obtain information, write summaries, organize and complete submission on Nagano), including scientific review of major study amendments,
- Develop informed consent documents based on regulations, supplied consent and institutional requirements,
- Prepare annual follow up for resubmission to REB, revise and resubmit consents based on protocol amendments as required,
- Coordinate special projects as required,
- Interact with patients and families regarding but not limited to recruitment, and questionnaire administration,
- Assist in the development of physician-initiated research protocols, data worksheets, tools to be used within the study, and reviewing appropriateness, correctness and feasibility of the study,
- Liaise with other members of the study group to produce ongoing input prior to and after implementation of the study,
- Act as point of contact for the research team who have questions or are experiencing problems with data collection or interpretation,
- Answer questions regarding eligibility, registration and specimen submission,
- Provide communication and education for the research team as well as to patients and families on study-related issues at time of activation and throughout the course of the study as needed, alerting them to any special study issues or requirements,
- Prepare protocols for use, read and have a general knowledge of protocol, maintain a diagnosis/priority list specific to the department’s needs in order to facilitate patient entry (i.e., eligibility, initial testing, staging criteria, and research specimen work up),
- Initiate and maintain a research chart which includes original consent, eligibility, response criteria, roadmap, and general correspondence,
- Participate in preparing, reviewing and maintaining institutional Standard Operating Procedures (SOPs),
- Adhere to ethical guidelines and Good Clinical Practice (GCP),
- Protect participants and participants’ rights through REB relations,
- Participate in audits and monitoring visits when appropriate,
- Manipulate bodily fluids as required by specific protocols,
- Obtain pathology and/or biology materials as required by protocol and submit material according to protocol guidelines and shipping regulations where appropriate, organize and prepare shipment packages for specimen send out,
- Attend patient review rounds (i.e. in-patients, out-patients, late effects, neuro-oncology),
- Attend educational events and meetings as required to advance expertise and maintain certification,
- Prepare and present training to all clinical staff (e.g. proper documentation, reporting, and protocols),
- Assist in other departmental needs,

**Replacement Responsibilities**:

- Assist other Clinical Research team in their duties (vacation, illness, deadline coverage),

Website of the organization

Education / Experience
- Work experience: minimum of two (2) years of experience in clinical

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