Source Systems Specialist I

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
• Provide telephone, email and web support for the CTMS end user community, assisting them by logically diagnosing and resolving basic to intermediate issues, as well as ensuring a timely escalation of unresolved issues to next level of support
• 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.
• Display professional, efficient communication skills though timely follow up using the company's telephone, TEAMS, or email communication formats.
• 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 confidence
• Strong interpersonal skills
  
  

PHYSICAL 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 position
• May 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 regulations
• Required 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