Work Performed
•Identify, screen, consent, recruit, and follow-up study participants, perform study specific assessments, educate, and advise patients regarding protocol requirements.
•Ensure that all aspects of study are performed within International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and Tri-Council guidelines, as well as institutional, site and study specific Standard Operating Procedures (SOPs).
•Perform data collection and entry in a timely and accurate manner.
•Preparation of study documents including ethical submissions, regulatory documents, clinical study agreements, and hospital research approvals; supervise trainees and fellows to submit REB documents for studies; maintain accurate records of REB approvals, submit renewals and amendments as required.
•Design and develop study data collection forms for implementation on REDCap or other related programs.
•Build relationships with individuals investigators, medical fellows and graduate students to facilitate successful implementation and recruitment for new clinical studies.
•Develop study advertisement, promotional and instructional material for study participant recruitment.
•Prepare and organize materials (e.g., documents, collection kits) for initial and ongoing patient follow up study visits.
•Maintain study related documents in regulatory/study binder ensuring accuracy and completeness.
•Assist with patient sample processing as needed.
•Help maintain databases which capture clinical, microbiome and dietary intake information from IBD patients.
·Participate in supervision of undergraduate co-op students to carry out research studies.
•Perform data collection and entry in a timely and accurate manner.
•Assist in data analysis and preparation of abstracts and manuscripts for publication for research projects.
•Work with investigators to generate study reports and meeting agendas, distribute meeting materials, and generate meeting minutes.
•Performs other related duties as required.