Jobbtitel: SrCRA / CRA2 - home based

Arbetsbeskrivning:

Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,200 working across 47 countries to provide comprehensive, yet flexible and responsive, services.

Chiltern is looking to recruit an experienced monitor based in Sweden to work in the role of Clinical Research Associate II (CRA II) or Senior Clinical Research Associate (SCRA). This role offers excellent exposure to all therapeutic indication types and a defined career development.

We encourage the development of CRAs into the lead function giving co lead responsibilities where possible and excellent exposure. We also welcome applicants that want to be career monitors.

Job Primary Functions:

- The successful applicant will be responsible for coordinating Phase I-IV clinical trials in Europe

- Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits.

- Assist with document submissions to local authorities

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

- Ensure that all study related communication including e-mail is tracked, printed and filed as required

- 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

- To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study

- Mentor and train other CRA?s

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

- Other Ad-Hoc CRA duties

Job Qualifications:

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

- Previous CRA experience within clinical research of approximately 14 months

- 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 using a clinical trial management system

- Preferable experience using a clinical trial management system (CTMS)

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

- Good oral and written communication, organizational skills and personal presentation

- The ability to communicate effectively in Swedish and English

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

Additional Information:

- This is a permanent, full time and home based role based in Sweden

- Work will be required away from Chiltern offices, at Sponsor offices, and may require national or international travel

- May also involve travel to meetings or attendance at conferences

- Overnight stays may be required

- No freelance applications or agency enquiries will be considered

- Please submit your CV and a detailed covering letter explaining why you are suitable candidate. If you do not submit a covering letter this may affect your application Please send your CV to simone.schaefer (at) chiltern.com

Arbetsgivare Namn: Chiltern International AB

Arbetsgivare adress: Box 2024 40311 Göteborg

Form av kontakt:
titel : telefon 1: () telefon 2: () mobil: e-post:

Arbetsgivare telefonnummer: 031-132790

Jobb kort beskrivning:
Biologists, botanists, zoologists and related professionals

Land: Sweden

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text