Senior Clinical Research Associate

Job Description

 

 

 

 

Pharma.Direct UK & Europe Ltd is bespoke Pharmaceutical recruitment consultancy based in Europe. Our Client seeking a Senior CRA.

 

Role:                Senior Clinical Research Associate

Location:          Austria

Responsibilities:

·         Provides support to Project Team and Clinical Operations Team.

·         Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects.

·         Demonstrates strong written and verbal communication skills.

·         Serves as primary contact for assigned research sites.

·         Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.

·         Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.

·         Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.

·         Verifies the rights and well-being of trial subjects are protected.

·         Reconciles site regulatory binder assuring collection and completeness of regulatory documents.

·         Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.

·         May support translations of essential documents.

·         May support submission of trials to IRB/IEC and regulatory authorities.

·         Verifies that written informed consent was obtained before each subject’s participation in the trial.

·         Verifies that the investigator is enrolling only eligible subjects.

·         Performs source data verification against Case Report Form/Electronic Data Capture entries   in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff. 

Requirements

  

Education

·         4 year college graduate, preferably with a healthcare or life science degree.

·         In lieu of a degree, candidates with 3 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.

 

Experience

·         Minimum of 3 years of experience in on-site monitoring of clinical studies

·         Monitoring experiences in several different indications and study types

·         Experience in all areas of monitoring (on-site, remote, etc.)

 Skills/Competencies

·         Strong written and verbal communication skills

·         Strong interpersonal skills

·         Expert monitoring skills to independently conduct all types of site monitoring visits

·         Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding)

·         Strong computer skills, including Microsoft Office

·         Comprehensive knowledge of GCP/ICH guidelines

·         Proficiency in medical terminology

·         Able to exercise judgment within defined procedures and practices and to determine         appropriate action independently.

·         Exceptional attention to detail

·         Superior problem-solving skills

·         Assist in training/mentoring guidance and presentation skills.

·         Ability to work in a matrix environment

·         Exceptional time management and organizational skills

 

To apply

For further details or to apply for position please contact Fandi Hatib at Pharma Direct fandi@pharmadirect.org.uk or call +441234 223359.