Clinical Research Coordinator Assistant
The Clinical Research Coordinator Assistant under the supervision and direction of the Supervisor, CPMA co-leads assigned clinical research projects in accordance to Protocols, Standard Operating Procedures (SOPs), and applicable regulations.
- Assist the CRC on monitoring and tracking the progress and execution of each study to ensure compliance with client timelines, study Protocol, SOPs, GCP guidelines and applicable regulations.
- Review of assigned protocols, eCRF and other protocol documentation for accuracy and feasibility
- Work with CRCs and other members of the study teams to ensure study performance meets or exceeds client expectations
- Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data
- Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrolment logs etc
- Assists with organizing study files, including but not limited to regulatory binders, study specific source documentation and other materials as required
- Additional tasks may also be assigned based on training, experience and qualifications i.e. vital signs, blood collection, assignment of more complex studies (first in man/innovator) training etc.
- Perform any other duties as required, as training and experience allow.
- A minimum of a post-secondary degree or diploma in a sciences or relevant experience in a CRO.
- Knowledge of research principles, ICH/GCP guidelines and applicable regulations
- Demonstrated experience with MS office (Word, Excel, Outlook, PowerPoint)
- Strong interpersonal and communication skills with a team focus
- Ability to work effectively and efficiently in a fast paced, multitasking environment
- Ability to anticipate problems and provide solutions in a timely manner
- Detail oriented with effective decision making and problem solving skills
- Ability to work flexible hours both day and evening shifts including weekdays and weekends.
1-2 years previous clinical research experience in CRO/pharmaceutical industry required