JobPosting
title: Clinical Research Associate - Ohio/Michigan
description: Title: Clinical Research Associate This role is located in either Ohio or Michigan. The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. Responsibilities: Contributes to the selection of potential investigators. In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. Actively participates in Local Study Team (LST) meetings. Contributes to National Investigators meetings, as applicable. Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. Updates CTMS and other systems with data from study sites as per required timelines. Manages study supplies (ISF, etc), drug supplies and drug accountab…
date posted: 2026-06-10T16:09:08.831Z
valid through: 2026-08-09T16:09:08.831Z
direct apply: false
occupational category: Scientific
industry: Healthcare
skills: ICH-GCP
skills: GMP/GDP
skills: Risk Based Quality Management
skills: Clinical Study Management
skills: Study drug handling
skills: Data management
skills: Valid driving license
hiring organization: Cell Therapy Site Management & Monitoring
job location: Place
  address: PostalAddress
    address locality: Michigan City
    address region: Indiana
    address country: US
employment type: FULL_TIME
base salary: MonetaryAmount
  currency: USD
  value: QuantitativeValue
    min value: 112154
    max value: 168231
    unit text: YEAR