Clinical Research Data Specialist

3 days ago

Victoria, Canada Island Health Full time

**Job Description**:
In accordance with the Vision, Purpose, and Values, and strategic direction of the Vancouver Island Health Authority ( Island Health), patient and staff safety is a priority and a responsibility shared by everyone; as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

The Clinical Research Data Specialist plays an integral role on a study team, responsible for data management activities across multiple clinical trials and clinical research projects. Reporting to the Manager, Clinical Research, the Clinical Research Data Specialist is responsible for the collection, management, confidentiality and quality assurance review of study participant clinical and research data. Main responsibilities include data entry, query processing, data reporting, and data management of multiple projects. Activities also include assisting with study start-up activities including regulatory document preparation and submission, training of clinical research team members regarding data management requirements for each study, and attendance at clinical trial project meetings.

**QUALIFICATIONS**:
**Education, Training And Experience**:
A level of education, training and experience equivalent to a Bachelor's Degree (minimum) in a health research-or health informatics related field.

**Skills And Abilities**:

- Three years of working experience in a data management capacity in a clinical or health research environment, at a private (biopharmaceutical, medical device, clinical research organization or Sponsor) or public institution.
- In-depth knowledge of Health Canada Food and Drug Act, Division 5, Part C, International Committee on Harmonization Part E6 - Good Clinical Practices, and US Food and Drug Act regulations part 21 CFR and 45 and part CFR 46 pertaining to clinical trials.
- Functional understanding of the Freedom of Information and Privacy Act (FIPPA), in particular section 35.
- Demonstrated knowledge of the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans and GCP requirements for protection of the rights of study participants.
- Excellent and mandatory attention to detail, organize information and multi-task/prioritize in a busy environment.
- Knowledge of and adherence to the principles of Good Data Management (in research) and general ethical guidelines as related to clinical trials including policies and principles of confidentiality, privacy, informed consent.
- Experience with Remote Data Capture (RDC) and Electronic Data Capture (EDC) systems preferred.
- Well developed communication skills (verbal and written) and ability to work well and communicate effectively with a diverse range of individuals.

**Job Requirements**:

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