Clinical Research Associate Job at McInnis Inc., Ridgefield, CT

Q1VhcWlZVHhRcnREYXp2K0QrNFdFTTZJaWc9PQ==
  • McInnis Inc.
  • Ridgefield, CT

Job Description

The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The CRA may also assist with data management, vendor management and site monitoring as needed.    

Duties and Responsibilities 

  • Act as the primary point of contact with assigned clinical study sites during start-up activities; 
  • Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned sites; 
  • Review site-level documents needed for IRB/EC/REC approval; 
  • Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan; 
  • Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations; 
  • Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates, subject withdrawals, etc.); 
  • Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors; 
  • Collaborate with clinical study site and sponsor to troubleshoot and provide appropriate solutions to study-related issues, as appropriate; 
  • Assist in patient recruitment activities; 
  • Assist with the development of study-related documents as requested; 
  • Prepare accurate and timely study reports as requested; 
  • Work independently and under general supervision. 

Education

  • Bachelor’s degree (or higher) in nursing, health sciences or related field; 

Qualifications

  • Experience with clinical trial contract and budget negotiations 
  • Finance experience preferred 
  • Minimum of two years of CRA experience, with clinical site monitoring experience preferred; 
  • Strong oral and written communication skills; 
  • Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance; 
  • Proven organizational skills and the ability to manage multiple priorities; 
  • Strong computer skills; 
  • Ability to travel with adequate prior notification  

Job Tags

Full time, Contract work,

Similar Jobs

Roush Honda

Automotive Prep Porter Job at Roush Honda

 ...toward a common goal. When you work at Roush Honda, You Own It! Automotive Prep Porter Job Summary The focus of a Porter is to...  ...Prep Porter Qualifications Strong organizational and time management skills Outgoing and self-motivated personality Exhibit a... 

Get It Recruit - Finance

SBA Loan Closer - Hybrid - Remote | WFH Job at Get It Recruit - Finance

An established regional bank is expanding its SBA team and is looking for an experienced SBA Loan Closer to join their dynamic group. This role offers the flexibility of a hybrid remote work environment, allowing you to balance both in-office and remote responsibilities...

Dunwody White & Landon, P.A.

Probate Paralegal Job at Dunwody White & Landon, P.A.

 ...Description: Dunwody White & Landon, P.A., a South Florida trust and estate law firm, seeks a paralegal for the Coral Gables office with the following: At least 5 to 10 years of experience as a probate paralegal. Thorough knowledge of estate and trust... 

The LiRo Group

Project Manager Job at The LiRo Group

 ...We have an immediate need for a Project Manager in Albany, NY. Come join our team! We are looking to build services and capabilities through the growth of our key asset- our staff. Ranked among the nation's top A/E firms by Engineering News-Record, LiRo-Hill provides... 

Xavier University of Louisiana

Vice President of Marketing and Communications | Xavier University of Louisiana Job at Xavier University of Louisiana

 ...understanding of all marketing and communications disciplines including but not limited to: strategy, brand positioning, media, marketing, advertising, public relations, public affairs, digital, web, social, and external affairs. Xavier University of Louisiana is an equal...