Clinical Trial Associate

Job Title: Clinical Trial Associate

Contract Term: 6 months to start; could extend

Hybrid - 3 days onsite required in Cambridge

Experience required:

Sponsor exp is REQUIRED

Preferred Qualifications

Project Coordination Required

Leading the trial is preferred

Experience with global studies, using an outsourced CRO model

Experience in clinical drug development

Experience with regulatory affairs, including IND/CTA submissions

Position Overview: The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing clinical trials. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.

Key Responsibilities:

Organize/maintain tracking systems and set up tools to support the conduct of a clinical study 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 set up

Setup and organize Sharepoint and central study files

Coordinate training for the assigned clinical study

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

Minimum Qualifications

BS/BA degree or equivalent and at least one year experience in clinical operations in Sponsor / CRO company with 3+ 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

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records."