Company: Docs Global (Continental Europe)
Reference: Ref AS-019120
Closing Date: 23 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
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
- 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)
- Prior hematology / oncology clinical study experience
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.
2 Globeside, Globeside Business Park
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