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Source Systems Specialist I

3 months ago

Toronto, Canada Centricity Research Full time

POSITION FUNCTION

The Source Systems Specialist is responsible for the development and maintenance of source forms throughout the life of a study to allow for efficient and accurate data collection, meeting study-specific guidelines. In addition to source development, they will provide support for the CTMS end user community by logically diagnosing and resolving basic to intermediate issues.

ESSENTIAL FUNCTIONS
- Review Sponsor protocols, eCRF guidelines, and other study-specific documentation to develop source forms to allow for efficient and accurate data collection to meet study-specific guidelines
- Program forms within the CTMS system as per study specifications, FDA guidelines, and company standards
- Maintain study builds from startup to closeout, updating forms as needed based on protocol amendments and updated company guidelines
- Maintain working knowledge of the CTMS system, including new releases and new products
- Communicate with internal staff to ensure the collection of study-specific documents needed for source form development (eg. Protocols, eCRF Guidelines, etc)
- Remote work compatible by displaying independent and proactive work habits
- Promptly attend scheduled meetings as required, available and eager to engage in department discussions.
- Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations Other duties and responsibilities as assigned

EDUCATION/EXPERIENCE
- **Minimum**: Associates Degree in applicable field, or equivalent experience
- **Preferred**: 1 Year of Source Specialist or CRP (Clinical Research Professional) experience

CORE COMPETENCIES/SKILLS
- Prerequisite (Essential): _
- Excellent communication skills (verbal and written)
- Excellent computer skills (MS Word, Excel and Outlook)
- Attention to detail
- Ability to manage time efficiently
- Self-directed
- Teamwork & Collaboration
- Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning Flexible & Adaptable
- Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines _Foundation:_
- Conflict resolution
- Receptive to feedback
- Empowering & Developing others
- Empathy Skills
- Planning and organizing skills
- Excellent problem-solving skills
- Achievement oriented
- Analytical ability
- Initiative
- Decision making _Leadership:_
- Forward thinking
- Innovative
- Creative
- Strategic thinking
- Self confidenceStrong interpersonal skillsPHYSICAL DEMANDS
- Physical demands include but not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
- Frequently required to complete work on the computer in a seated positionMay be required to lift light boxes (10 - 20lbs)

WORKING CONDITIONS
- Modern medical office environment or home office environment
- Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulationsRequired to perform duties in relation to HIPAA, PIDEDA, and other local privacy regulations

Some positions may require overnight/weekend hours

**BENEFITS**:

- Opportunities to work with internationally renowned physicians
- Comprehensive health benefits, competitive salary
- RRSP or 401(k) contribution matching
- Continued opportunities for growth & development; yearly education allowance
- Paid holiday closures and employee appreciation days off