Company: Docs Global (Continental Europe)
Reference: Ref AS-019576
Closing Date: 23 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Docs is recruiting for a Sr CRA to join an international Biotech company based in Milan city! As SR CRA you will perform SSU axctivities and only 1monitoring on site per week! Office based in Milan!
Roles & Responsibilities of the position
As Senior CRA you will be assigned clinical sites and ensure compliance of assigned studies with national and international regulatory requirements.
? Conduct pre-study, initiation, interim monitoring and close-out visits.
? Train assigned investigative sites in GCP and assure these sites are conducting research according to protocol and national laws.
? Review investigative sites’ regulatory documentation and ensure compliance with GCP.
? Monitor informed consent process.
? Serve as main point of contact with assigned investigative sites.
? Review and update clinical files at 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.
? Create file trip reports, follow-up letters and maintain telephone contacts for assigned investigative sites.
? Evaluate and resolve data queries.
? Evaluate study query trends and interact with Study Team in improving data quality.
? Assist investigative sites with the timely and accurate resolution of queries.
? Attend, participate and present at Investigator Meetings, as requested.
? Effectively negotiate and manage clinical study budgets for assigned investigative sites.
? Act as a liaison between Celgene and assigned investigative sites.
? Identify new investigators for future Celgene studies.
? Assist in the review of draft Case Report Forms and Protocols, as requested.
? Participate in study and clinical team meetings. Communicate clinical performance data to other members of the management and scientific team.
? Assist in mentoring CRAs, as requested.
Education: BSN/BS/MS or BA required
Experience: 4 or 5 years monitoring experience and a minimun of 1 year experience in start up and regulatory activities
Therapeutic areas Oncology, Onco-hematology
Knowledge of Microsoft Office applications especially Excel
English: Fluent spoken & written
Good interpersonal skills demonstrated as proactive, enthusiastic, and independent thinker
Ability to collaborate and build strong relationships with all functions involved in the trial
We offer a permanent contract, full time and client office based in Milan and very low trave
For an immediate consideration please send your most recent resume directly to email@example.com.
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are: Our People, Excellence, Accountability, Integrity, Openness.
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2 Globeside, Globeside Business Park
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