Clinical Trial Associate
3 weeks ago
Clinical Trial Associate Job Summary
We are seeking a highly organized and detail-oriented Clinical Trial Associate to join our team at Beacon Hill. As a Clinical Trial Associate, you will play a critical role in the execution of clinical trials, working closely with our Clinical Trial Managers to ensure the successful coordination of documents and activities associated with the conduct of investigational clinical studies.
Key Responsibilities:
- Organize and maintain tracking systems to support the conduct of clinical studies from start-up to close-out.
- Assist with the development and review of clinical documents, including protocols, ICFs, and clinical study plans.
- Schedule and coordinate study meetings, materials, and agendas, recording and disseminating decisions and actions.
- Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision.
- Facilitate vendor engagement from RFP distribution through to final contracting and PO setup.
- Setup and organize Sharepoint and central study files.
- Coordinate training for assigned clinical studies.
- Manage study laboratory sample tracking and vendor management support.
- Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages.
- Support Clinical Operations team with specific projects.
- Effectively communicate with study team members and work closely to address challenges.
Requirements:
- BS/BA degree or equivalent and at least one year of experience in clinical operations in a Sponsor company with 1+ years strongly preferred.
- Knowledge of drug development, clinical operation processes, and documentation, including study start-up procedures, maintenance phase, and study close-out procedures.
- Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations.
- Experience with eTMF; ability to directly apply essential document knowledge to file documents.
- Effective communication, organizational, and interpersonal/team skills.
- Proficient in MS Excel, Word, and PowerPoint. Knowledge of MS Project and SharePoint preferred.
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
- Participate in inter-departmental workgroups to create or enhance processes.
- Strong attention to quality/detail.
- Good organizational and time management skills.
- Willingness to work in a flexible environment.
Preferred Qualifications:
- Experience with global studies, using an outsourced CRO model.
- Experience in clinical drug development with knowledge of First in Human trials.
- Experience with regulatory affairs, including IND/CTA submissions.
- Experience working on dermatology.
About Beacon Hill:
Beacon Hill is a leading provider of clinical trial management services, dedicated to delivering high-quality results and exceptional customer service. Our team of experienced professionals is passionate about advancing medical research and improving patient outcomes.
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