Clinical Research Coordinator- Pediatric HematologyOncology (Research Institute)

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 clinical trials under this portfolio are from Phases I to IV.


General Duties
Coordinate a variety of studies related to therapeutics biology tissue banking and quality of life (this includes opening new studies applying for contracts patient recruitment enrolment follow-up and data entry case management of protocol participants data organization and storage grant and budget development logging billable study activities and tracking of study funds preparing for audits and being familiar with research protocols in order to advise the research team)
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
Complete Research Ethics Board (REB) applications in collaboration with Principal Investigator and submit for approval follow up on queries and changes through final approval
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 departments 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
Assist in other departmental needs.

Website of the organization

/ Experience

Education: Diploma of College Studies (DEC)
Other education considered an asset for this position:
Bachelors degree
Certified Clinical Research Professional (through SoCRA or ACRP or equivalent organization) preferred.

Work Experience: Minimum of 2 years of related experience with experience in clinical trials or oncology being an asset.

Required Skills

Excellent communication skills in French and English spoken and written
Strong analytical skills and ability to synthesize complex material clearly
Excellent interpersonal and leadership skills
Ability to work effectively in a team and autonomously
Exceptional organizational skills meticulous and detail-oriented
Motivated and enthusiastic
Able to work in an environment with children and young adults with cancer
Comprehensively use computer software and technology.