Clinical Research Associate (In-House)

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 Research Associate.  Candidates can be located anywhere North Chicago.

 

 

The qualified candidate will:

· A BSc or BA degree in a biomedical or related life science, or nursing qualification

· 3+ years monitoring/clinical trial experience

· Good clinical knowledge with an understanding of medical terminology

· An understanding of the basics of physiology and pharmacology

· Understanding of the principles of ICH GCP and regulatory requirements

· Experience of the clinical research process and terminology

· Preferable experience using a clinical trial management system (CPMS)



· Experience as a CRA on single site and/or multicentre trials.



 

Essential job functions include:



Clinical Monitoring Activities:

1.To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits.

2.To identify potential centers for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required.

3.To ensure that investigator site files are assembled appropriately and that all required documentation is in place prior to release of clinical supplies

4.To be proactive in all dealings with study sites. To ensure that all study related communication including e-mail is tracked, printed and filed as required.

5.To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA. 

6.To prepare, or facilitate the preparation of Multicentre and/or Local Ethics Committee / IRB submission documentation as defined by local requirements.  To ensure that EC/IRBs are updated regarding protocol amendments, SAEs etc.

7.To provide assistance in the production of Case Report Forms.

8.To track CRFs collected during monitoring visits to data management.

9.To liaise with data management regarding data flow and data query processing.

10.To ensure that the interim safety reports are provided to EC/IRBs as per country requirements.

11.To assist the Project Manager in the production of Status Reports.

12.To be accountable for ensuring that all relevant study documentation is present for study sites.

13.To undertake other project related administrative tasks (i.e. meeting minutes, recruitment tracking, site file preparation) as appropriate, as assigned by the Project Manager and LCRA.

14.To assemble files and ensure documents for the trial master file accurately reflect the progress of the study.

15.Assist in the organization of meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.

 

 

Required skills and abilities include:

· Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications

·Good oral and written communication, organisational skills and personal presentation. The ability to communicate effectively in English.

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

 

 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