Clinical Trial Associate
Hiring Company: Dart NeuroScience
Job Code: 17-024 #801753
Location: San Diego
Description: Job Summary:
Provide support to the Clinical Operations functional line in project-specific tasks, tracking and the overall management of clinical trials.
Assist with the preparation of documentation, receipt, collection, and initial/ongoing review of site regulatory documentation. Confirm completeness of documents, track dates, and distribute to appropriate team members for review.
Create and maintain study central files for the duration of the study including assisting in the file review and reconciliation for audits, and preparing study files for archival.
Maintain and update project tracking tools and databases, which may involve contacting others to gather information;
track and assist with study start-up activities including site identification, selection and recruitment, regulatory document collection and review.
Assist in the planning, organizing and executing of project-specific meetings, CRA training meetings, and Investigator meetings.
Actively participate and assist with the preparation and distribution of meeting agendas and minutes.
Create and maintain project-specific binders and related files as needed to house study records during the trial.
Provide support in the development and distribution of study newsletters.
Support the team by providing information and supplies, as requested.
Maintain project-related status reports and support Clinical Operations staff with maintenance of project timelines.
Engage and correspond with vendors and contractors to ensure timely receipt of study documents and materials.
Process and track invoices and expense reports from vendors and contract personnel.
Ensure finalized clinical trial agreements/contracts are properly tracked, maintained, filed and forwarded to the sponsor/clinical site.
Prepare correspondence, spreadsheets and presentations utilizing Microsoft Office.
Bachelor’s degree and 1-2 years industry experience
Proficiency in Microsoft Word, Excel, and PowerPoint is required.
Experience with Microsoft Project and Access is a plus.
Excellent interpersonal, verbal and written communication skills.
A flexible attitude with respect to work assignments and new learning.
The ability to read and interpret documents such as safety rules, SOPs and work instructions, procedure manuals, write routine reports and correspondence, and must be able to speak effectively in meetings.
Knowledge of ICH-GCP and the clinical trial process.
Experience in review of site regulatory documents.
Must possess a customer service demeanor; must demonstrate a strong sense of urgency, teamwork, keen attention to detail, the ability to plan, organize and to prioritize multi-task workload.