Clinical Trial Associate
1 month ago
Beacon Hill Life Sciences - Boston is seeking a highly skilled Clinical Trial Associate to join our team. 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 conduct of 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.
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