The Division of Endocrinology is in search of a part-time Clinical Research Project Assistant (CRPA) who will be on site to assist with Principal Investigator Initiated Drug Trial(s) as well as Observational Clinical Research Studies according to Regulatory and Institutional Ethics Policies/Guidelines.
Start Date: ASAP
Description of Position:
This is an onsite CRPA position. The CRPA will be responsible to work collaboratively providing support to the Principal Investigator, Clinical Research Project Manager and Senior Project Coordinator as described below but not limited to.
Here's What You'll Get To Do:
Research Participants
Recruitment and Retention as well as Scheduling and Study Visits
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Assist in in-person and virtual recruitment of eligible participants across multiple studies
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Assist in scheduling participants for study visits across different studies
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Assist in submitting EPIC orders for study visits
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Assist in calling and reminding subjects about study related instructions, and any other requirements they need to complete before the visit
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Assist in sending out study materials to participants in preparation for study visits
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Support coordination of multi-departmental study visit activities
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Assist in carrying out study visits and associated activities
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Assist in the organization and coordination of focus groups, including participant scheduling, logistics, and materials preparation
Laboratory
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Assist in centrifuging and processing human biological samples
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Assist in keeping laboratory logs up to date
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Assist in aliquot sampling for analysis
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Ship and receive lab samples to and from collaborators and service providers
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Assist in organizing and storing samples in freezers
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Assist in keeping up to date (i.e., ordering) with all lab supplies required for studies[Training on handling human biological samples will be provided.]
Study Documentation
Data Entry, Database
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Assist in maintenance of all essential research documents for studies
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Conduct health chart reviews
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Contribute to data entry for each subject and for each study visit (anthropometric, blood work, tests results, questionnaires) into Source Documents and transfer of data into Case Report Form (CRF) and/ or ACCESS/ REDCAP or Excel File Database, and 2nd read of all data transferred from one format to the another
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Assist in obtaining investigator signature on study documentation
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Assist in updating study tracking logs
Research Ethics Board (REB), Regulatory and Sponsor Requirements
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Assist the clinical research project manager/coordinator with preparation and submission of REB Applications, Study Amendments and Renewals
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Contribute to study start-up activities, including preparation of recruitment materials, participant-facing documents, and study visit workflows prior to activation
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Keep up to date regarding regulations and policies governing clinical research
Academic:
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Assist in collecting data for academic projects
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Assist in liaising with biostatistician in providing him/her data for data analysis
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Assist with abstracts/manuscripts/posters/presentations
To be successful at assisting in all tasks listed above the CRPA will be expected to gain adequate knowledge of study protocol(s) and Manual of Operations (MOO) related to studies.
Here's What You'll Need:
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Minimum University Undergraduate Degree (B.Sc.) required
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Minimum of 2 years' experience in clinical research is required, with human clinical trial experience preferred
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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)
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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
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Demonstrated initiative, a willingness to learn and the ability to be self-directed as well as an effective team player
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Excellent problem-solving, organizational and time management skills
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A commitment to understanding and aiding in the pursuit of equity, diversity and inclusion objectives
Employment Type: Temporary, Fixed-Term, 6-month contract
Hours of Work: 14 hrs per week (0.4 FTE)
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