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Clinical Trial Specialist (2 openings)

Ultragenyx Pharmaceutical Inc.

Location:
Novato, CA
Posted Date:
4/2/2014
Position Type:
Full time
Job Code:
CTS: 20140113
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Research,

Job Description

The Clinical Trial Specialist (CTS) supports moderately complex clinical trial activities. The CTS works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's.  The CTS assists with vendor oversight and management.  Identifies issues in a timely manner and escalates to management as appropriate.  The CTS may complete monitoring visit report review and/or perform on-site monitoring.   The core duties and responsibilities of the CTS are delineated below.

Responsibilities:  
•   Manages Site Essential Documents review during study start-up, maintenance and close-out period
•   Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
•   Ensures tracking of essential documents are received and filed in the CTMF, reviews site documents (including site-specific informed consent forms)for accuracy and follows up as needed
•   Ensures tracking of patient status throughout the study at investigative sites
•   Provides clinical team support with CTMF filing and management
•   Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
•   May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
•   May perform routine monitoring at limited clinical sites
•   May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs
•   Assists in the preparation of, and may present at investigator vendor meetings and workshops
•   Actively involved in the performance of study feasibility assessments
•   Adheres to study timelines, quality, and budget for assigned studies
•   Provides rapid action to address both internal and site QA findings from audits
•   May coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
•   Routinely participates in department and clinical trial team meetings and may participate in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)

Requirements

•   Bachelors’ degree or higher
•   4 years industry experience preferred, in a scientific or medical field, with at least 2 years working specifically on clinical trial coordination and site management
•   Previous Site monitoring experience
•   Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
•   Basic knowledge of therapeutic area or disease
•   Understanding of study phases and general knowledge of how they apply to clinical development
•   Advanced knowledge of Word, Excel, and PowerPoint.
•   Knowledge of the principles and practices of computer applications in database management
•   High degree of customer focus towards internal and external stakeholders.  
•   Strong interpersonal and collaboration skills.  
•   Strong verbal and written communication skills required.
•   Able to handle multiple tasks and deadlines.  
•   Ability to identify issues and take appropriate actions.
•   10-30% travel may be required

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