Remote - Clinical Trial Specialist

A highly reputable biopharmaceutical corporation is currently hiring a qualified Clinical Trial Specialist to work remotely in the United States.

Position Summary:

• The Clinical Trial Specialist (CTS) is responsible for providing logistical support for one or more clinical trial programs.
• 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:

• Actively involved in the performance of study feasibility assessments.
• Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms).
• Manage the collection, review, and approval of regulatory documents from clinical sites.
• Coordinate investigational product release activities across clinical sites.
• Manages and tracks study specific payments.
• Create study-specific site budgets.
• Initiate, maintain, and reconcile the Trial Master File.
• Assists in the preparation of Investigator and Study Coordinator Meetings.
• Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs.
• Coordinate communication of tracking information within the study team and to the clinical sites.
• Develop and review Standard Operating Procedures.
• Serve as a subject matter expert for the CTS role on initiatives and working groups.
• Mentor Clinical Trial Associates.
• May be responsible for the following activities:
• Manage ancillary vendors, such as a specialty lab.
• Assist with study-specific training of Clinical Research Associates
• Perform site initiation, routine monitoring, and close-out visits at a limited number of clinical sites, as well as co-monitoring with Clinical Research Associates.
• Review site visit reports, under the direction of the Clinical Program Manager or designee
• Negotiate aspects of study-specific site budgets.

Requirements:

• Bachelor Degree or equivalent is required (scientific or healthcare discipline preferred)
• 3 plus years of clinical research experience
• Previous experience in clinical trial coordination and/or site management
• Understanding of study phases and general knowledge of how they apply to clinical development.
• Working knowledge of ICH Good Clinical Practice guidelines
• Able to handle multiple tasks and deadlines.
• 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.
• Able to identify issues and take appropriate actions.
• Highly effective verbal and written communication skills
• Must have the ability to build and maintain positive relationships with management and peers.
• Experienced using computer applications including spreadsheets, email, word-processing software, and web-based systems.
• 10% travel may be required.