Randstad Clinical Research Associate in Danbury, Connecticut

Clinical Research Associate

easy apply

  • apply with indeed

job details:

  • location:Danbury, CT

  • salary:$30 - $50 per hour

  • date posted:Wednesday, October 11, 2017

  • job type:Temporary

  • reference:S_577779

  • questions:alexandra.anderson@randstadusa.com858/410-8541

easy apply

  • apply with indeed

description

This position is office-based; only candidates local to Danbury, CT, or willing to relocate to Danbury will be considered.

Responsibilities:

Clinical Monitoring, Site Management

  • Conduct Site Qualification, Initiation, and Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)

  • Serve as primary site contact; establish and maintain regular communication with clinical sites

  • Train Investigators and site staff on protocol and study-specific processes

  • Assist with distribution, collection and tracking of essential regulatory documents for site compliance and audit readiness

  • Prepare and complete monitoring visit reports and letters, and effectively document site communications per the CMP

  • Review Informed Consent Forms (ICFs), completed Case Report Forms (CRFs), and other site documentation to verify subject protection, accurate data recording (source data verification), and adherence to the protocol and governing regulations

  • Identify and address routine site issues including protocol deviations and escalate to Study Lead (SL)

  • Review/complete quality control (QC) checks of Site Trial Master File (TMF)

  • Supply, Sample Management

  • Assist with the assembly of specimen collection kits

  • Assist with sample handling, shipment and receipt

  • Clinical System Utilization

  • Basic use of clinical databases and other associated data tracking tools

  • Assist in user acceptance testing of clinical study database(s)

  • Demonstrate basic proficiency of the Clinical Trial Management System (CTMS)

Working hours: Monday-Friday, normal working hours

Skills:

Qualifications

--Bachelor's degree in related field

--2-4 yrs. clinical monitoring experience; external clinical monitoring experience required

--Knowledge of clinical trial practices and regulations

--Knowledge of clinical monitoring and trial design

--Proficient use of clinical trial databases; proficient knowledge of technical computer systems

--In Vitro Diagnostics (IVD) experience or medical device experience

--Experience with IBM Clinical Development (data capture system), a plus

--Comfortable with 50% travel

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.