Research I

4 weeks ago

Edmonton, Canada Alberta Health Services Full time

The Clinical Trials Unit is recruiting a Research Coordinator to provide support to Investigators for clinical research trials. You will be assigned to the Infectious Disease Group located at the Clinical Sciences Building. The main responsibility of this position includes study management including screening and recruitment of potential participants, obtaining informed consents, completing protocol specific procedures, feasibilities, preparing ARISE ethics applications, developing informed consents, submitting annual renewals, SAE reporting within the required timelines, close out reports and operational approvals. You will be responsible for organizing participant on-going follow-up visits, performing protocol-specific assessments, arranging for appointments and facilitation of ongoing therapy with exact adherence to protocol specifications. You will be responsible for the development of study specific source documents, and for ensuring source documents are received and reviewed appropriately (such as lab results, hospital diagnostic tests etc). You will prepare and organize participant charts and case report forms. It will be your responsibility to maintain the site ISF and ensure that all regulatory documentation is reviewed appropriately. Any participant counseling and education on study specific protocol requirements, treatment/visit schedules and training on any data collection tools will be part of your tasks. You will ensure that ongoing training by study staff on all study procedures and documents is completed and documented appropriately. As a Research Coordinator, you will require exceptional organizational skills that are necessary to ensure trial information is timely, accurate, valid and to the sponsor's satisfaction.
As a Research I, you will be working with research teams which are generating and disseminating new knowledge that assists with advancing the understanding of health disciplines and various health and medical concerns. Working under the guidance of the principal investigator, you will be responsible for preparing and submitting research documents, collecting and reviewing a variety of information related to the study, and monitoring study compliance. You will also assist with the recruitment of study participants and initiate consenting of study and/or trial participants and may complete lab work to support research activities.
Diploma or degree in a health or science related field. Registration with applicable professional association or college where required.
2-3 years current experience working with Pharmaceutical Clinical Trials (Phase 1-4) and Investigator Initiated Trials. Current experience with University of Alberta ARISE ethics applications and Alberta Health Services processes. Current experience with inpatient and outpatient trials, consenting of research participants, contract and operational approval submissions using the NACTRC online system. Current experience in vaccine trials (both mRNA and adjunctive), Hep B trials and Adaptive platform trials. Knowledge of clinical trial regulations and guidelines (ICH-GCP, Health Canada and FDA). Current experience with electronic data capture and database programs including REDCap, Spinnaker, imedidata and Medable systems. Knowledge of medical terminology. Experience with Sponsor, Health Canada or FDA audits. Experience with computer programs (excel, word, power point). Health Canada Division 5, GCP certification, Clinical Research Coordinator training through CITI, TCPS2 and N2 SOPs. Connect care and Netcare. Strong interpersonal and communication skills.Excellent problem-solving skills and the ability to work in a team environment. You must be able to handle multiple demands with short timelines while remaining sufficiently flexible to accept new workloads as necessary.
As required.

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