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Clinical Trial Specialist

The Steely Group

Remote, MA(remote)

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JOB DETAILS
SKILLS
Billing, Clinical Research, Clinical Support, Clinical Trial, Cross-Functional, Customer Support/Service, Data Analysis, Drug Development, Forecasting, Healthcare, Identify Issues, Informed Consent, Metrics, Multitasking, Pharmacy, Purchase Orders, Records Management, Regulations, Reporting Dashboards, Standard Operating Procedures (SOP), Startup, Time Management, Willing to Travel
LOCATION
Remote, MA
POSTED
3 days ago

The Clinical Trial Specialist (CTS) is responsible for providing logistical support for one or more clinical trials. This position will work closely with cross-functional teams to ensure site start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials. 

 Responsibilities:
  • Supports development, review, and maintenance of study documents such as site instructions, site specific Informed Consent Forms, Lab Manual, Pharmacy Binder, Study Reference Manual, study plans, etc.
  • Set up and maintain trackers, tools, dashboards, and reports study metrics to support the clinical trials
  • Manages one or more small-scope vendors; may support management of complex vendors
  • Oversee contracts of assigned vendors including invoicing, purchase order monitoring, and forecasting with study lead oversight
  • May be assigned site management responsibilities
  • Files study documents in the electronic Trial Master File (TMF), maintain essential documents lists, participation and coordination of TMF completeness reviews, and may serve as the main study contact for Records Management
  • Contributes content to team meetings, including Study Management Team meetings

Requirements / Qualifications:
  • Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
  • Typically two years of direct work experience in Clinical Research
  • Understanding of study phases and general knowledge of how they apply to clinical development
  •  Able to handle multiple tasks and deadlines, and identify issues and take appropriate actions
  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
  • Must have the ability to build and maintain positive relationships with management and peers
  • 10% travel may be required

About the Company

T

The Steely Group

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