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Job Details

Clinical Research Associate (m/w)

Company: Docs Global (Continental Europe)
Location: München,Germany
Reference: Ref AS-022762
Closing Date: 23 Aug 17
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS has partnered with a global biopharmaceutical company focused on medicines for cancer and inflammatory disorders. To strengthen their monitoring team we are looking for dedicated CRA interested to join up.

Requirements:

Roles & Responsibilities of the position

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

Job Requirements

• Relevant scientific or nursing degree
• Prior experience as a Clinical Research Associate
• 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 Phase I and hematology / oncology clinical study experience preferred

Remuneration & other details

- Competitive base salary based on experience level
- Initial 12 months contract with option for extension and more
- Full time
- Office based in Munich
- Compensatory time-off
- Contribution to pension scheme
- Work from a sponsor perspective

Apply for this job: Clinical Research Associate (m/w)

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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