Research Assistant

Hamilton Health Sciences•Hamilton, ON

About The Position

Support Research Coordinator to oversee the operation and management of research projects. Adhere to Good Clinical Practice and incorporate GCP requirements in all stages of research projects from start up to close up. Adhere to regulatory and local requirements (i.e. annual safety reports, periodic safety reports). Adhere to timelines and milestones. Provide support to all collaborators (sites, countries, CROs, Sponsors) on a regular basis through communication. Liaise with internal and external collaborators involved with research projects, to support logistics of daily operations. Compile, review, and file essential documents. Help with training and orientation of study sites and staff. Help develop Manual of Operations and other study support tools, reports, and trackers. Help create and test data reports, databases, audit case report forms (CRFs), and related programs. Respond to data-related questions and query from internal and external partners. Coordinate logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies. Prepare for meetings and teleconferences. Implement all study related amendments requested by the Principal Investigator. Respond to daily inquiries and facilitate communications on behalf of the central site. Perform activities related to major protocol deviations. Regular communication with external parties. Help provide training to external study staff. Prepare and attend regular meetings, manage and document summary of minutes and lines of action(s). Support the study coordinator in the design of required study management plans required for the conduct of the research study (e.g., data management plan, monitoring plan, adjudication plan, investigational product (IP) management plan, safety management plan, etc.). Assist with initial, annual and project amendment ethics committee submissions. Support with the design, development and implementation of study REDCap database, and other required study systems. (i.e. Randomization, websites, etc.). Design of the study database, case report forms and required edit checks, in accordance with protocol and study requirements. Support with routine monitoring of regular data collection activities, including quality control reports, data entry and data review/validation using pre-existing or newly created reports.

Requirements

Bachelor's degree in a relevant field of study, or related experience equivalent.
2 years of relevant clinical trial experience.
GCP Certificate.
Excellent communication skills.

Nice To Haves

TCPS2 training
Experience and knowledge of REDCap database build and maintenance

Responsibilities

Oversee the operation and management of research projects.
Adhere to Good Clinical Practice and incorporate GCP requirements in all stages of research projects.
Adhere to regulatory and local requirements (i.e. annual safety reports, periodic safety reports).
Adhere to timelines and milestones.
Provide support to all collaborators (sites, countries, CROs, Sponsors) on a regular basis through communication.
Liaise with internal and external collaborators involved with research projects, to support logistics of daily operations.
Compile, review, and file essential documents.
Help with training and orientation of study sites and staff.
Help develop Manual of Operations and other study support tools, reports, and trackers.
Help create and test data reports, databases, audit case report forms (CRFs), and related programs.
Respond to data-related questions and query from internal and external partners.
Coordinate logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies.
Prepare for meetings and teleconferences.
Implement all study related amendments requested by the Principal Investigator.
Respond to daily inquiries and facilitate communications on behalf of the central site.
Perform activities related to major protocol deviations.
Regular communication with external parties.
Help provide training to external study staff.
Prepare and attend regular meetings, manage and document summary of minutes and lines of action(s).
Support the study coordinator in the design of required study management plans (e.g., data management plan, monitoring plan, adjudication plan, investigational product (IP) management plan, safety management plan, etc.).
Assist with initial, annual and project amendment ethics committee submissions.
Support with the design, development and implementation of study REDCap database, and other required study systems (i.e. Randomization, websites, etc.).
Design of the study database, case report forms and required edit checks, in accordance with protocol and study requirements.
Support with routine monitoring of regular data collection activities, including quality control reports, data entry and data review/validation using pre-existing or newly created reports.