Clinical Research Assistant

Hamilton Health Sciences•Hamilton, ON

About The Position

This role involves supporting clinical research studies by identifying and recruiting eligible participants, managing study procedures, maintaining accurate records, and ensuring compliance with protocols and regulations. The assistant will be responsible for participant follow-up, drug supply management, documentation, and communication with various stakeholders including medical staff, ethics committees, and study sponsors.

Requirements

College Diploma or equivalent experience.
Experience with clinical trials.
Demonstrated above average computer skills.
Knowledge of Epic EMR for patient information.
Demonstrated above average organizational skills.
Demonstrated strong initiative and drive and the ability to be self-directed.
Demonstrated interpersonal, communication and teamwork skills.

Responsibilities

Identify eligible participants for various studies.
Recruitment of study subjects including informed consent process, randomization and implementation of study protocol procedures.
Maintain screening logs/records.
Completion of Case Report Forms (CRF’s).
Collection and transmission of source documents.
Review of Quality Control Reports and resolution of queries.
Schedule follow up with study participants as per study protocol.
Manage drug supply for study participants.
Arrange consultations with MD’s as necessary.
Complete local Ethics Committee applications, renewals and study closeout applications.
Maintenance of study binders and logs.
SAE management and reporting.
GCP training renewal.
Host monitoring visits.
Education of front line health care staff re: study protocol and procedures.
Attend site initiations, investigator meeting, etc.
Attend weekly study team meetings.