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Beacon Hill · 1 week ago

Clinical Trial Associate

Cambridge, MA

Contract

Hybrid

Entry, Mid Level

1+ years exp

Beacon Hill is a company that values diversity and is seeking a Clinical Trial Associate. The role involves assisting with daily clinical trial execution activities, supporting Clinical Trial Managers, and coordinating various clinical documents and vendor engagement.

Staffing Agency

H1B Sponsor Likely

Hiring Manager

Shakira Irizarry

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

Qualification

CRO experienceClinical drug developmentRegulatory affairsETMF experienceMS ExcelMS WordMS PowerPointProject managementSharePoint knowledgeEffective communicationOrganizational skillsInterpersonal skillsAttention to detailTime management

Required

CRO exp is REQUIRED

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

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

Medical Affairs exp a plus

Project Management or coordination preferred

Experience with global studies, using an outsourced CRO model

Experience in clinical drug development

Experience with regulatory affairs, including IND/CTA submissions

Knowledge of MS project and SharePoint preferred

Company

Beacon Hill

Glassdoor3.9

Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.

Founded in 2000

Boston, Massachusetts, USA

1001-5000 employees

http://www.beaconhillstaffing.com

H1B Sponsorship

Beacon Hill has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (38)

2024 (94)

2023 (76)

2022 (60)

2021 (77)

2020 (86)