JOB SUMMARY:

In accordance with the Mission, Vision and Values, and strategic directions of Provincial Health Services Authority patient safety is a priority and a responsibility shared by everyone at PHSA, and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.
The Data Administrator, Clinical Trials performs assigned data management procedures, capturing and recording clinical trials data, which is performed in accordance with trial protocol, procedures, guidelines and professional standards of practice. Receives work direction and supervision from the Data Coordinator, Clinical Trials.

QUALIFICATIONS:

Education, Training and Experience
Completion of a recognized Health Record Administration Program with eligibility for membership in the Canadian College of Health Records Administrators at the Certificate level, one (1) years recent related experience or an equivalent combination of education, training and experience.

Skills and Abilities

• Demonstrated ability to perform data capture, management and retrieval using an automated information system
• Knowledge and understanding of ICH Guidelines
• Demonstrated aptitude for detail
• Demonstrated ability to operate related equipment
• Demonstrated interpersonal skills including the ability to communicate effectively both verbally and in writing
• Demonstrated ability to deal with others effectively
• Physical ability to perform the duties of the position

Under the supervision of the Data Coordinator, Clinical Trials;

1. Performs basic data management functions related for studies of a less complex nature, in collaboration with other members of the Clinical Trials and Heath Care Team and by performing duties such as:

• Organizing and maintaining study files and documentation.
• Ensuring that records (paper and electronic) are complete by checking for deficiencies in information and are in compliance with ICH-GP standards.
• Collecting, extracting and inputting data pertaining to clinical trials specifications utilizing in-house and external databases.
• Contributing to the development and maintenance of data collection tools and regulatory documentation.
• Maintaining and creating user accounts.

1. Under the direction of the Data Coordinator or designate assigned to specific studies, captures clinical trials data, as specified in the protocol and in collaboration as required with the Clinical Trials Team, by performing duties such as:

• Completing study case report forms and other documents within the required timeframe
• Retrieving or requesting data by identifying selection parameters for retrieval
• Utilizing coding systems and resources as required to code, input and upload data as pertaining to Clinical Trials.

1. Completes data collection for follow-up, as specified in protocols by obtaining information from reports, charts, outside physicians and hospitals.
2. Determines data quality/integrity of assigned work by reviewing the data capture for accuracy and completeness. Updates and corrects deficiencies with other appropriate members of the Clinical Trials team.
3. Reports assigned information to sources such as other Agency departments and outside organizations, following established time schedules and procedures.
4. Attends and participates in meetings relevant to data capture, management and clinical trial implementation.
5. Participates in continuous quality improvement activities by performing duties such as providing input/feedback to supervisor on processes and opportunities for process improvement.
6. Tracks and collects appropriate credentials, registrations and training completion for investigators and staff to ensure compliance with Good Clinical Practice guidelines.
7. Performs a variety of clerical support functions such as photocopying and faxing of documents and recording workload information.
8. Performs other related duties as assigned.