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Study Administrator
4 weeks ago
POSITION FUNCTION
The Study Administrator (SA) performs a variety of administrative and clinical activities to assist the research team in the conduct of clinical studies. The SA will have an understanding of study protocols and will assist to coordinate and manage study activities completely and accurately.
ESSENTIAL FUNCTIONS
General
- Gain familiarity of protocols, GCP, and Centricity Research SOPs/WPs and processes
- Assist in chart screening, database query reviews, and recruitment outreach efforts as needed
- Assess overall filing, documentation, reporting, and archiving processes on an on-going basis to identify improvement opportunities and to assist in implementing process improvements
- Archive clinical research documents, track, and maintain all archived documents upon completion of a study
- Assist with on-site quality control
- Attend regularly scheduled site meetings, sponsor training or other meetings as required by the study
- Manage front desk supervision at sites that require this support and serve as backup to Administrative Assistant (in sites with this position)
- Support ordering and coordinating office and medical supplies as needed
- Perform other administrative and clerical duties as required by CRPs and Research Management
Study specific
- Create, maintain, update and organize the Investigator Site File, ensuring compliance to GCP and Centricity SOPs/WPs and processes
- Download and distribute files from portals (e.g., ethics, study specific, etc.)
- Create and maintain the logs and documentation required per study
- Document receipt, maintain inventory, organization, and documentation of Investigational Product and other study supplies
- Prepare research and participant source and study templates, as required
- Perform QC for completeness prior to data entry
- Perform accurate, complete, and timely data entry of CRFs and query resolution
- Support CRPs in addressing monitor findings, and follow-up
- Provide technical support and/or training to study participants where required
- Perform specified tasks of Lab Specialist (based on qualification and designation), if required by the site
- Perform role of un-blinded research staff (e.g. Investigational Product dispensation and/or QC) if required by site and protocol
EDUCATION/EXPERIENCE
**Minimum**:
- Canada: High School Diploma with experience in medical office setting
- US: HS/GED/ Certified Medical Assistant or other medical training
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 are 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.
- Required to follow all healthcare industry OHSA and OSHA guidelines
- Required to perform duties in relation to PHIPA, HIPAA, PIDEDA
- Some positions may require overnight/weekend hours
**BENEFITS**:
- Opportunities to work with internationally renowned physicians
- Comprehensive health benefits, competitive salary
- RRSP and 401(k) contribution matching
- Continued opportunities for growth & development; yearly education allowance
- Paid holiday closures and employee appreciation days off
