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

d0lxZDlJSSs1QnBPNkk3Qm1FWHZSUk13NVE9PQ==
  • McInnis Inc.
  • Ridgefield, CT

Job Description

Job Description

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

Powered by JazzHR

pc6irHPzE6

Job Tags

Contract work,

Similar Jobs

Lothorian Pools

Landscape Architect Job at Lothorian Pools

 ...Job Overview We are seeking a talented and detail-oriented Landscape Architect / Designer to join our dynamic team. This role...  ...Preferred Qualifications ~ Bachelors degree in Landscape Architecture or related field. ~2+ Years of professional experience in landscape... 

Plastic Components Inc

Injection Molding Process Technician Job at Plastic Components Inc

Join our team at Plastic Components, Inc., a leader in precision plastics manufacturing, and contribute to the cutting-edge production of molded plastic parts utilized across various industries. As an Injection Molding Process Technician, you will leverage our advanced... 

Citywide Insulation Inc.

Insulation Installer Job at Citywide Insulation Inc.

Job Description Job Description Commercial and Residential Installers Pay: $20 - $27 per hour Immediate full time openings, Experience helps, WILL TRAIN. Drivers License and medical card a plus. Medical, Dental, Disability and life insurance. 401K, PTO, and Holiday...

Shearer's Foods

Food Manufacturing Processor Job at Shearer's Foods

 ...FOOD MANUFACTURING PROCESSORAFTERNOONS 4PM TO 12AM MONDAY THRU FRIDAY WITH SATURDAY FLEX OT12 HOUR DAY SHIFT 7AM TO 7PM WORKING EVERY OTHER FRI/SAT/SUNTRAINING RATE $21.80 - ($1 shift premium for afternoon shift)Your seat at the best snacks table:~Set... 

Villa Healthcare

Wound Care Nurse RN Job at Villa Healthcare

Westland, A Villa Center is seeking a Wound Care Nurse RN to join their team! As a Wound Care Nurse RN, you will have the distinctive role that specializes in the care of patients with wounds, ostomies, or continence disorders. You will also provide each resident with routine...