Clinical Trial Assistant
- Full-Time
- Guilford, CT
- Ce3
- Posted 4 years ago – Accepting applications
Job Description
Job Duties:
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- Maintenance and coordination of the logistical aspects of clinical trials according to GCP and ICH relevant SOP’s
- Act as a primary contact for the clinical trial team supporting the Lead StM/ PM
- Execute the technical aspects of all site regulatory documentation and compliance during the conduct of clinical research studies
- Participation as an active member of the project team
- Assess and put in place action plans to ensure project deliverables are met according to agreed timelines and milestones and quality expectations
- Supports implementation of technology enabled processes and identifies new technology solutions to improve overall efficiency within the Clinical Operations group
- Develops effective and productive partnerships with strategic business partners as well as client team members to ensure clarity of role, deliverables and achievement of project goals and objectives
- Supports the internal function for data cleaning for both paper and Electronic Data Management or other electronic technologies utilized as CTMS and other electronic data capture tools.
- Self-directed in task execution to ensure project deliverables are met
- Proactive problem solver who either solves issues on their own or raised them to the appropriate level of management to facilitate a solution
- Liaise with outside vendors to ensure study deliverables are met.
- Works closely with Sponsors under the direction of the Lead StM /PM in support of project services being delivered.
- Maintains quality control and quality assurance process for project support, liaising with sponsors as necessary to obtain and investigate feedback on quality and turnaround times.
- Address any issues in a timely and responsible manner and put control measures in place to prevent recurrences
- Responsible for maintaining Trial Metric Workbook / CTMS for assigned projects , tracking all information and production of status reports for project team and sponsors
- Supports the PM/ StM in the forecasting and ordering all clinical trial supplies.
- Responsible for collecting, maintaining, and tracking essential Regulatory documents; collaborating with sites as needed to ensure compliance
- Responsible for ensuring all study documents are archived based on the appropriate guidelines/policy
- Participation in the development of edit specifications and data cleaning conventions
- Associates degree (or equivalent) or comparable industry experience
- Prefer basic clinical development and business experience familiar with the clinical and study management operational requirements
- Strong organizational skills, technical capabilities in computers, software packages ( power point, excel, access, project, publisher, visio)
- Excellent written and verbal capabilities that facilitate internal and external communications
- Experience in the navigation and execution of data cleaning activities, specifically in EDC applications preferable.
- Ability to multi-task across a broad set of tasks without direct supervision on a daily basis
- Self-motivation and direction in alignment with the overall company goals and objectives
- Exercises sound judgment and problem solving in situations where there is limited information directing the solution to the problem.