Y037 - Clin. Res. Project Coord.-RI

Y037 - Clin. Res. Project Coord.-RI

15 May

15 May



The Division of Endocrinology is in search of a full-time Research Coordinator (RC) to coordinate a Multi-centered PI-Initiated Drug Trial and support in the coordination of other studies including Industry-Sponsored drug trial and observational studies according to Institutional and Regulatory Guidelines.

Overall Job Description:
The Research Coordinator possesses and applies highly advanced scientific knowledge of innovative research principles, theories and concepts. The RC coordinates research studies according to regulatory and institutional guidelines and requirements. This includes coordinating patient recruitment and data collection, study administration, preparing consents and paperwork required by the Research Ethics Board,

and organizing data entry and analysis. The RC also assists in the preparation of study results, including presentations, progress reports, and manuscripts. The RC establishes contact with not only SickKids Employees, but also considerable contact with community hospitals for participant recruitment and other academic hospitals or clinical trial sites to oversee overall trial conduct of multi-centered PI-Initiated Drug Trial.

Here are some tasks that you will get to do

The RA will be responsible for providing support to the Principal Investigator(s), Senior Manager, Lab Manager and other research staff (i.e. nurse) in the following capacity, but not limited to:

Research Ethics Board (REB), Regulatory and Sponsor Requirements

Prepare and submit REB Applications, Study Amendments, Renewals as well as any other documents required by the ethics board (i.e. adverse event reporting etc.) for all studies under your coordination, and oversee the ethics requirements of clinical trial sites for studies under your coordination
Support the preparation of regulatory submission for PI Initiated (SickKids Sponsored) Drug Trial, as required
Participate in audits and monitoring for studies under your coordination that are required by SickKids or industry sponsor
Keep up to date all essential documents for PI Initiated (SickKids Sponsored) and Industry Sponsored Drug Trials as required
Keep up to date with the regulations and policies governing clinical research

Protocol/ Manual of Operations

Gain adequate knowledge of Protocol and Manual of Operations (MOO) for studies under your coordination as required to be able to carry out study requirements
Develop and monitor timelines for study.
Develop guidelines, procedures and standards for all studies as required
Support the development of Protocol/ Manual of Operations as well as training materials and presentation(s) for Site Initiation Visits for studies under your coordination as required, and support the training of clinical trial sites

Study Participants, Study Visits and Documentation

Assist PI in confirming eligibility of potential patient (i.e. eligibility criteria checklist)
Recruit study participants and oversee recruitment progress at other clinical trial sites
Obtain Informed Consent and Re-consent participants enrolled in the study as required
Initiate and maintain a research chart that will include original consent, patient protocol documentation, general correspondence, source documentation and case report forms
Organize materials to facilitate protocol adherence, including study binders and checklists of eligibility
Work collaboratively with the research team and other departments/service providers within SickKids and external to the institution to plan, organize, and carry out all study visits

Study Logs and Database/ Data Entry:
Maintain study logs (i.e., pre-screening log, screening log, and enrollment logs as well as study tracking log)
Input all study data into REDCap Database


Plan, organize and carry out laboratory research requirements in collaboration with Lab Manager
Ensure Lab Logs are kept up to date (i.e. temperature logs, shipment logs, and sample logs) and samples from all clinical trial sites are received and processed or stored according to protocol

Academic and Administrative:
Support the write-up of study progress reports, abstracts and manuscripts as well development of posters and presentations
Conduct literature reviews and keep current with study literature
Liaise with biostatistician for data analysis and interpretation
Support grant writing and grant application process
Prepare agendas for research meetings: action plans and deadlines

Here are the Qualifications you need

MSc in a relevant health related field is preferred with at least 3-5 years of clinical research experience in human clinical trials
Possesses current knowledge of regulations and policies governing clinical research (e.g. Tri-council Policy Statement, ICH Guidelines, Good Clinical Practices, and Health Canada and FDA regulations)
Strong communication skills, both oral and written to be able to directly and effectively interact with research team members as well as patients and their families
Demonstrated initiative, a willingness to learn and the ability to be self-directed with minimum supervision as well as an effective team player
Excellent problem-solving, organizational and time management skills
Have a valid driver’s license to travel to other community hospitals for recruitment of potential study participants as needed

The original job offer can be found in Kit Job:

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