Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms RSS Feed RSS Feeds RSS Feed PharmiWeb Candidate Blog RSS Feed PharmiWeb Client Blog

Job Details


Company: Docs Global (Continental Europe)
Location: Austria
Reference: Ref AS-019120
Closing Date: 23 Oct 16
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. DOCS is hiring aClinical Research Associate Home based(m/w) of all experience levels to work closely with one of the most successful pharmaceutical companies. If you are a CRA willing to work home based (or office based in Vienna) and open for a new challenge, we would like to get to know you.


Roles & Responsibilities of the position

1. Monitor assigned investigative sites
- Plan and conduct pre-study, initiation, interim monitoring and close-out visits
- Train assigned investigative sites in GCP and ensure these sites are conducting research according to protocol and regulations
- Monitor compliance with protocol, informed consent process, drug accountability, GCP/ICH and applicable local laws
- Serve as main point of contact with assigned investigative sites
- Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP
- Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of what happened to a subject while participating in the study
- Organize delivery of supplies (e.g. study medication, lab kits, CRFs) as required
- Monitor inclusion rate and discuss action plan to ensure completion of the study within planned timelines
- Create and properly file trip reports, follow-up letters and telephone contacts for assigned investigative sites
2. Evaluate and Resolve Data Queries
- Evaluate study query trends and interact with Study Team in improving data quality
- Work with Data Management and assist investigative sites to achieve timely and accurate resolution of queries
3. Attend and participate at Investigator meetings
4. Assist IRB/IEC-submissions / correspondence e.g.
- Update submissions, e.g. protocol amendments, safety reports
- Ensure translation and back translation of study specific documents as required
5. Maintain electronic storage of documents including transfer to TMF
6. Support home-based CRAs
7. Up to approximately 60% mainly domestic travel required, including overnight stays

Job Requirements

Skills/Knowledge Required:
- Prior experience as a Clinical Research Associate or related field
- Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated tactfulness and diplomacy in dealing with study coordinators and physicians
- Knowledge of regulatory environment (GCP, relevant German laws)
- Excellent written and oral communication skills (German and English)

Skills/Knowledge Preferred:
- Prior hematology / oncology clinical study experience

Remuneration & other details

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Apply for this job: CRA

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.