Clinical Trial Specialist

Job type:
on-site
Start:
07/2014
Duration:
n.a
From:
Real Staffing
Place:
South San Francisco
Date:
07/04/2014
Country:
flag_no USA
project ID:
736447

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This project is archived and not active any more.
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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