Remote - Clinical Trial Specialist
Remote - Clinical Trial Specialist
Beacon Hill
United States
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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.
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Project Management -
Industries
Biotechnology Research
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