Job Summary:

In accordance with the Purpose, Vision, Values and Coast Salish Teachings, and strategic direction of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

The Database Coordinator reports to the Manager, Clinical Trials Unit and establishes, maintains, and improves data quality processes and tools to manage data for clinical trials and research studies in the Clinical Trials Unit. The role ensures consistent and accurate use of electronic data capture (EDC) systems, such as REDCap or MS Access, by designing electronic Case Report Forms (eCRFs), edit checks, and reports, performing data quality reviews, managing user access rights to the EDC systems, creating training materials, and providing support to research teams. The Database Coordinator works closely with the Database Management Lead on creating validation documents, testing cases for validation, and generating queries. The Database Coordinator provides feedback regarding data quality and liaises with site personnel, other departments, or other healthcare professionals to ensure that procedures and policies are followed and improved as needed.

Duties/Accountabilities:

1.    Creates and updates the specifications for Case Report Forms (CRFs) for clinical trials and research studies using protocol-specific information and standards as per the Principal Investigators and/or Project Managers. Provides recommendations and inputs to CRF development.  Clarifies data needs and prioritizes requests in conjunction with the manager.
2.    Liaises with Database Management Lead at PCTO about design and implementation of clinical trial and research databases. Performs validation and documentation such as Validation Plan, User Requirements Specifications, Testing Protocol, Traceability Matrix, and Validation Report. Develops data management plans.
3.    Performs user acceptance   testing and validation of the research databases, including updates, to ensure functionality and compliance to defined expectations. Creates and runs test cases, summarizes the test results and reports/resolves any issues.  Documents the testing and validation according to current SOPs,
4.    Uses a variety of data/report query tools, spreadsheet, graphics and word processing software to manage data. Under the direction of the Database Management Lead, implements edit checks and queries/reports using EDC platforms such as REDCap, including testing and documentation.  
5.    Creates data management reports. Specifies report content and layout.  Liaises with the PIs, statisticians, scientists, lab managers, etc. as needed. Reports any data issues to Project Managers and Principal Investigators.
6.    Performs data quality review on a routine basis. Reviews participant data entered into the study databases for completeness and any errors (e.g. inconsistencies, out-of-range values, impossible values, etc.) and identifies any patterns. Issues data queries and provides support where needed and works with sites to help resolve them.  
7.    Exports data and creates data summaries for the PI, statistician, and/or scientists upon request.
8.    Creates user roles and permissions and assigns user rights appropriately. Troubleshoots user access issues and updates or revokes user rights as needed.
9.    Develops and maintains operational related documentation including training documents, data management plans, data entry manuals, data dictionaries, and processes to support applicable clinical trials and research studies.
10.    Provides end-user training and support including assisting with troubleshooting, identifying options and implementing appropriate action including escalating issues for technical assistance. Provides training to ensure study personnel clearly understand data entry requirements and database functionality.  Maintains communication with users and documents incidents.
11.    Performs other related duties as assigned.

Qualifications:

Education, Training and Experience
•    Graduation from a Health Information Management Program and two (2) year’s recent related experience in clinical trials, research database management, use of data/database querying tools, such as REDCap or MS Access, and documentation, data retrieval, manipulation and presentation of data including experience in technical documentation or an equivalent combination of education, training and experience.

Skills and Abilities

•    Demonstrated ability to perform complex data capture, management, retrieval and analysis using relational database automated information systems.
•    Advanced data management and computer literacy.
•    Demonstrated knowledge of cancer based coding systems.
•    Demonstrated experience in data query, report and analysis tools.  
•    Demonstrated ability to operate Windows based software packages including MS Access, MS SQL query software, database applications, statistical analysis software, word processing and spreadsheet software
•    Demonstrated ability to communicate effectively both verbally and in writing.
•    Strong interpersonal and collaboration skills and the ability to establish and maintain effective working relationships internally and externally.
•    Excellent troubleshooting and organizational skills as well as great attention to detail.
•    Capable of identifying problems and developing creative solutions.
•    Ability to work under pressure with a diverse group of people, policies and procedures.
•    Demonstrated ability to be self-directed, express initiative yet work well within a team environment.
•    Demonstrated ability to handle multiple concurrent assignments.

** Please note: Support for nomination with the BC Provincial Nominee Program is not a guarantee, entitlement or an employee benefit after receiving a full time job offer with PHSA**