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

T0Nkb3U1cUdzRjlKaGx6K2dRLzNoTnNjS3c9PQ==
  • 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

Rishabh RPO

Agile Project Manager/Scrum Master Job at Rishabh RPO

 ...Job Title: Agile Project Manager/Scrum Master Location: Atlanta, GA Work Mode: Hybrid Duration: 6-9 Months RESPONSIBILITIES: Utilize Jira to assist the team in refining the sprint backlog, ensuring the creation and quality of Epics and Stories... 

Family

Live-In Nanny August 2025 Start Date Job at Family

Family seeking live-in nanny, au pair, babysitter to join our family in Greenwich, Connecticut. 45 mins train/drive outside NYC.Ideal candidate would be a self-starter, energetic, organized, warm and creative with an ability to handle multiple children. Previous nannies... 

Brookfield Properties

Assistant Property Manager Job at Brookfield Properties

 ...residential living. That's why, at Brookfield Properties, our portfolio features a wide range of...  ...Overview: Assists the Property Manager with the general administration of the property...  .../Bookkeeping.+ 1-2 years of required experience in Leasing, Bookkeeping, or Operations.... 

Northeast Healthcare Recruitment, Inc.

Hospitalist Nurse Practitioners & Physician Assistants Job at Northeast Healthcare Recruitment, Inc.

We are looking for Board-Certified Nurse Practitioners and Physician Assistants with at least one year of hospitalist experience to join our dedicated team just south of Boston.About the Role:Join a hospital with a closed ICU staffed by intensivists around the clock... 

Papa John's

Delivery Driver Job at Papa John's

 ... Health Benefits Promotion opportunities Locally owned Papa John's Pizza locations seeking drivers who like to take home cash daily working for a successful, well established, community minded company! Busy locations need more drivers! Flexible shifts available...