Clinical Data Management Assistant

The Clinical Data Management Assistant ’s purpose is to assist the coordinator with managing multiple clinical research studies as follows:

- Screening participants to ensure they meet inclusion/exclusion criteria of the study

- Recruiting patients and obtaining the informed consent

- Preparation for study visits including scheduling follow up visits, chart and clinic preparation

- Completing follow up procedures including taking vitals

- Administering study questionnaires including cognitive tools, delivering blood samples to the laboratory

- Retrieval of medical charts from hospital databases

- Enter study patient data entry in study databases and resolve queries

- Maintain essential and regulatory site documentation including ethics approvals per ICH-GCP guidelines

- Creating and updating various logs and tracking sheets (enrolment, visit procedures, follow ups, invoices and payments etc.)

- Creating data collection forms and updating these as needed

- Manage office supplies and invoices

- Participate in site meetings and trainings

- Bachelor's degree in a health related field of study.

- Minimum 1 year previous experience in multi-center research studies/clinical trials or other research projects in a clinical setting (Cardiology related preferably).

- Experience with EPIC or other medical records systems.

- Experience with multiple different databases (idatafax, Dacima, Medidata, Redcap).

- Working knowledge of ICH-GCP Guidelines and international research requirements (current GCP Certificate).

- Highly efficient computer skills, experience with the Microsoft office suite.

- Ability to work in a team environment.

Assets:

- Cardiology Related training or research work experience. 

- Familiarity with hospital departments/procedures (Medical Diagnostics Unit, Diagnostic Imaging, EP Lab, Research Lab, etc.