Company operating name: GVI-Clinical Development Solutions Inc.

Title of position: Clinical Research Associate (NOC 4165)

Job Duties

Oversee the subject recruitment rate and verify that the investigator is enrolling only eligible subjects
Verify that source data/ documents and other trial records accurate, complete, kept up-to-date, and maintained and ensure the reported data are verifiable from source documents
Ensure the rights and well-being of human subjects are protected, including but not limited to review ICFs, AE/SAEs, Health Authority documentation, and conduct Investigational Product Accountability
Verify that the investigator follows the currently approved protocol/amendment(s), ICH, GCP, SOPs, applicable regulations
Train investigator and site staff on protocol, study procedures, GCP Guidelines and regulatory requirements
Review Investigative Site File for accuracy, consistency, and compliance and request new or updated site-related essential and non-essential documents.
Perform clinical site selection, site initiation, interim monitoring and site closure visits
Monitor clinical trial progress to ensure data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards
Complete trip reports after each monitoring visit according to GVI CDS and sponsor standard operating procedures (SOPs)
Participate in the development of clinical protocols, case report forms (CRFs), informed consent forms (ICFs) and clinical study reports
Fulfill other Duties as Required
Act as the main line of communication between the sponsor and the Investigator

Terms of employment: Permanent Full-time Position

Wage

$60,840 a year for 30 hours per week plus life, dental, and accidental insurance

Qualifications

Bachelor’s degree from an accredited institution of higher education, preferably in a scientific or health care discipline, or equivalent combination of education, clinical research certification, and/or experience.
GCP Certification, or certification with SoCRA or ACRP preferred.
Professional accreditation such as CCRA, CCRC, CCRP strongly preferred
A minimum of 2 to 4 years of experience in clinical research with primary site monitoring responsibilities in CRO or pharmaceutical industry
Strong working knowledge of EDC systems and IVRS/IWRS
Knowledge of all applicable regulations and guidelines pertaining to the conduct of clinical trials on human subjects (i.e. ICH GCP, FDA and Health Canada regulations).
Must be a self-starter with a proven ability to work with minimal supervision.
Demonstrated proficiency in Microsoft Office applications, specifically Word, Excel, PowerPoint and Outlook
Excellent organizational, decision-making, and interpersonal skills
Excellent verbal and written communication skills with the ability to negotiate and liaise internally and with clients and investigators
Ability to travel up to 60% or as required.

TO APPLY:

Contact Information

Director of Operation: Ms. Coreen Bradley

Tel: (204) 477-7593

Email: CBradley@gvicds.com

Address: 4-1250 Waverley Street, Winnipeg, Manitoba, Canada R3T 6C6