Clinical Trial Associate
3 weeks ago
About Us
Beacon Hill Life Sciences is a leading staffing firm specializing in scientific and clinical talent. With our Boston office, we strive to provide top-notch professionals for your organization.
Job Title: Clinical Trial Associate - Study Execution Specialist
Salary Range: $60,000 - $80,000 per year, depending on experience
Job Description:
We are seeking an experienced Clinical Trial Associate - Study Execution Specialist to join our team. As a key member of our clinical operations team, you will be responsible for assisting with the execution of clinical trials from start-up to close-out. This role requires excellent organizational skills, attention to detail, and effective communication with cross-functional teams.
Responsibilities:
- Organize and maintain tracking systems to support clinical study execution
- Develop and review 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 projects with limited supervision
- Facilitate vendor engagement from RFP distribution through 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:
- Bachelor's degree or equivalent and at least one year of experience in clinical operations; 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 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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