Clinical Research Operations Specialist
2 weeks ago
Overview
At ICON Strategic Solutions, you will be joining the world's largest and most comprehensive clinical research organisation, powered by healthcare intelligence.
About the Role
We are seeking a highly skilled Clinical Trial Coordinator to join our team. As a key member of our operations team, you will play a critical role in ensuring the smooth execution of clinical trials.
Responsibilities:
- Trial and Site Administration:
- Update clinical trial databases (CTMS) and trackers;
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF;
- Assist with eTMF reconciliation;
- Execute eTMF Quality Control Plan;
- Regulatory & Site Start-Up:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions;
- Support preparation of submission package for IRB/ERC and support regulatory;
- Publish study results for GCTO and RA where required per local legislation;
- Quality & Oversight:
- Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required;
- Mentors/buddies junior CTCs (including but not limited to process requirements).
Requirements:
- Minimum 1-2 years in Clinical Research or relevant healthcare experience;
- Completed job training (office management, administration, finance, health care preferred) or B.A./Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
- Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications;
- Strong MS Excel skills required;
- Excellent negotiation skills for CTCs in finance area;
- Effective communication with external customers (e.g. sites and investigators);
- To qualify, applicants must be legally authorized to work in Canada, and should not require now or in the future sponsorship for employment visa status.
Compensation: $60,000 - $80,000 per annum, depending on experience.
Contact Information:
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