Clinical Trial Assistant
Ce3 - Guilford, CT
Employment Type : Full-Time
Job Duties:
- 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.
Specific responsibilities will include but are not limited to:
- 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
• Assist with invoice processing and site payments in conjunction with the Study Manager• Responsible for the execution, review and tracking of data queries for EDC or other electronic data capture technologies utilized.
- Participation in the development of edit specifications and data cleaning conventions
Qualifications:
- 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.