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Job Details

Clinical Research Associate/ Bulgaria

Company: Docs Global (Continental Europe)
Location: Nicosia,Bulgaria
Reference: Ref AS-023845
Closing Date: 22 Nov 17
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

If you are a reliable and positive personality and would like to contribute to the further success of a dynamic young company in a growing market, please send your CV and motivation letter in English to: Orsolya.Berke@docsglobal.com 0036703831286

Requirements:

Roles & Responsibilities of the position

• Performs investigator identification and site selection and conducts pre-study visits for qualification of investigators and sites;
• Prepares and facilitates site training and initiation;
• Verifies clinical data against source document during routine monitoring and assist ef-ficiently in query management process and IP accountability and reconciliation;
• Completes monitoring trip reports, reporting study progress, escalating issues related to the protocol, and ensuring patient safety and ICH/GCP compliance within EastHORN and/or Sponsor timelines and quality;
• Ensures all site queries are resolved and recorded in a timely manner;
• Organizes translation and provides final approval of study documents as required;
• Manages adverse event reporting and follows up accordingly;
• Prepares and negotiates study budgets and contracts for the site(s), investigator(s), and study vendors, and assists in obtaining contract signatures;
• Prepares, organizes, and oversees site, investigator, and vendor payments;
• Provides feedback and support during appraisal process, performs co-monitoring visits. Depending on experience, becomes involved (upon request) in other study management areas and staff training;
• Reviews and develops (upon request) study essential documents;
• Assists in business development when appropriate.

Job Requirements

• Minimum 2 years of monitoring experience
• Life sciences background is required
• University Degree in Medicine is an advantage
• Experience in Regulatory Submissions / local regulations is an advantage
• Excellent knowledge of the clinical trial process and ICH/GCP guidelines
• Experience with Electronic Data Capture is required
• Excellent organizational and time management skills to handle multiple priorities
• Flexibility to travel
• Excellent written and oral communication skills in Bulgarian and English

Remuneration & other details

You can be a part of an international Dynamic CRO company

Apply for this job: Clinical Research Associate/ Bulgaria

Contact Information:

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

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