Senior CTABeacon Hill Life Sciences - Boston • Cambridge, MA, US

Senior CTA

Beacon Hill Life Sciences - Boston • Cambridge, MA, US

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Job Description

Position Overview

The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s). This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). This position will work with internal team members and with external vendors and CROs. The position will work cross-functionally and collaboratively to support clinical operations activities for a product’s development.

Responsibilities :

Assist the Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with consistently high quality, in compliance with applicable SOPs and regulatory guidelines
Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems
Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs / central labs
Collaborate with CRO / appropriate vendors to ensure timely training and access to necessary systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)
Coordinate Project Team and departmental meetings, including associated documentation
Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials
Develop and maintain strong, collaborative relationships with key stakeholders within the organization, its CROs and vendors, and clinical sites

Qualifications :

BS in a science-based discipline preferred with 2 – 8+ years of experience in a clinical research environment

Basic understanding of drug development, including knowledge of ICH GCP guidelines to ensure the appropriate conduct of clinical studies

Self-motivated and comfortable with shifting priorities and change in a small company environment

Good verbal and written communication skills

Good time management skills

Excellent organizational skills and attention to detail

Willingness to learn, able to take (and apply) direction and ability to manage multiple, parallel tasks

Company Description

Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.

Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.

Company Description

Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP / outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.\r\n\r\nBeacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.\r\n\r\nWhether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.

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Senior • Cambridge, MA, US