Clinical Data Associate (CDA)

Chiltern International is a well established global contract research organization with offices throughout Europe, North America and India.  We were established in 1982 and have served pharmaceutical, biotechnology, and device companies in over 38 countries worldwide.  Due to our continued growth, Chiltern is seeking a highly motivated individual to join us as a Clinical Data Associate (CDA).  We are currently seeking candidates in the Bristol, TN area.

 



The CDA participates and executes the Data Management functions in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs).

 

The qualified candidate will:





· 2-year degree minimum. Bachelor’s degree preferred

· Related experience a plus

· Computer literacy

· Accurate keyboard skills

· Basic understanding of medical terminology

· Experience of the clinical research process and terminology

· Effective communication skills including coordination skills, good personal presentation, oral and written communication skills

· Experience working in a team environment under time and resource pressures

· Understands the principles of ICH-GCP

 

Essential job functions include:

 

Data Management Activities:

· Provide input and assistance in the design of Case Report Forms (CRFs).

· Perform any necessary interpretations of compare output and provide feedback to DM Project Leader for resolution and database edits in DM

· Assist in preparation of data entry guidelines for selected projects

· Assist in the creation of test data for entry screens and edit checks

· Test data entry screens as per data entry guidelines and CRF for selected projects

· Create, issue and update the database with resolved data queries

· Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes

· Performs the filing and archiving of CRF’s in DM

· Work concurrently on multiple projects

· Perform all tasks to relevant Chiltern and/or Sponsor SOPs, ICH or other regulatory guidelines in DM

· Work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the Data Management Project Leader (DMPL) or Sr. Data Management Project Leader (Sr.DMPL)

 

Performance and Quality:

· Conduct all activities according to defined project specific quality and performance standards in addition to relevant SOPs, ICH/GCP and project requirements

· To adhere to SOP training requirements for the CDA II role as per the SOP Training Matrix

· To ensure timely completion and documentation of all training requirements

· Have awareness of project-specific quality and performance standards and ensure that these are understood

· To proactively review training materials on an on-going basis to ensure that they are up to date and relevant for the purposes intended

· To proactively involve and provide valuable inputs in project coordination

 

General Duties:

· Liaise with other members of the Chiltern Project team

· Undertake any activity as set by the line manager

· Ensure that all internal systems are routinely updates as appropriate (e.g. timesheets, expense reports, financial reports, etc.)

 

 

Required skills and abilities include:

· Good communication skills when dealing with sponsors and supporting colleagues

· Able to organize multiple ongoing tasks, and understand the differing priorities

· Confident dealing with internal clients and external clients

· Good understanding of the work performed by other Chiltern International functions and how they interact

· Previous experience in Data Management.

· Confident dealing with external and internal clients and providers

· Able to be proactive and use initiative

· Proven ability to work independently with minimal supervision

· Proven good interpersonal and communication skills 

 

 

Chiltern’s unique corporate culture encourages a healthy balance of personal life and work.  We offer an excellent salary and benefit package to include medical, dental, vision, company matching 401K, excellent vacation & holiday, paid life insurance, AD&D, long and short term disability and many other employee incentives.  If you have the experience required and feel you are the dynamic person we are looking for, please forward your resume in a Word document via email to:  uscareers@chiltern.com