CRA Junior Certified

June 3, 2013 by · Comments Off on CRA Junior Certified
Filed under: Clinical Research 

DOCS – a leading provider of global resourcing solutions to the Drug Development industry-  is recruiting in Italy for an international Pharmaceutical company!

Excellent opportunity for an Home/ Office based CRA . The role is Permanent, national monitoring for studies mainly in Oncology, CNS and Immunology areas.

The Role and your Responsibilities

As a CRA (Clinical Research Associate) your position will involve the following:
Performing initiation, monitoring and close out visits.
Collecting high quality data.
Contributing to documentation design.
Assisting the Project Manager as required.
Adhering to SOP’s, ICH-GCP and other local regulations.

What is Required

With a University degree in Biology, Biological Science, Biotechnology, or equivalent,  you will have previous monitoring experience in international studies including study start up and close out (at least 2 years).

In addition, you will also require:

Excellent knowledge of ICG GCP guidelines and expertise to review and evaluate medical data.

Fluency in English.

Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.

Ability to produce accurate work to tight deadlines.

Computer literate with Microsoft Office.

Certification as a CRA is mandatory.

Please send your cv to alessandra.arensi@crasecrets.com

Study Start-up Associate (Contracts)

March 6, 2013 by · Comments Off on Study Start-up Associate (Contracts)
Filed under: Clinical Research, Regulatory Affairs 

A leading biopharmaceutical company  is looking for an enthusiastic and experienced  Study Start-up Associate (Contracts)

Role and Responsibilities

– Prepare study-specific Clinical Trial Agreements templates with investigators and institutions for study management teams
– Negotiate budget costs and contract language with the appropriate party at the sites
– Assist with developing a budget template and determining reasonable procedure costs after thorough reading of the protocol
– Liaise with CTA Department to resolve individual contract language regarding issues that fall outside the allowable contract terms
– Maintain status tracking tool for individual sites for each study
– Maintain open communication and participate in regular meetings/teleconferences with study teams

What is Required

– BA/BS with at least 3 years of experience in pharmaceutical clinical research including contract preparation and negotiation
– Expert knowledge of ICH and GCP guidelines
– Good communication skills are mandatory
– Demonstrated ability to be customer oriented to the investigator and site personnel in order to achieve high customer satisfaction levels
– Demonstrated ability to prioritize and manage multiple complex tasks
– Demonstrated ability to attend to detail and solve problems
– Demonstrated ability to work with multiple study sites in several therapeutic areas                                                                                                                                                                                              – English written & spoken at fluent level

What is offered

This is a great opportunity to join an international company working on a cutting-edge projects!                                                                                                                        The position is Office based (Milan) or Home base (previous experience required)
Full time for 6 months with possibility of Permanent Contract
Interesting Salary

If you’re interested , please send an English Cv at alessandra.arensi@docsglobal.com quoting the reference AS- 2400.

CRA Home/Office Based Milan

October 11, 2012 by · Comments Off on CRA Home/Office Based Milan
Filed under: Clinical Research 

DOCS – a leading provider of global resourcing solutions to the Drug Development industry-  is recruiting in Italy for ICON!

Excellent opportunity for an Home/ Office based CRA to work for a Leading CRO.

The role is Permanent, national monitoring for studies mainly in Oncology, CNS and Cardiovascular areas.

The Role and your Responsibilities

As a CRA (Clinical Research Associate) your position will involve the following:
Performing initiation, monitoring and close out visits.
Collecting high quality data.
Contributing to documentation design.
Assisting the Project Manager as required.
Adhering to SOP’s, ICH-GCP and other local regulations.

What is Required

With a University degree in Biology, Biological Science, Biotechnology, or equivalent,  you will have previous monitoring experience in international studies including study start up and close out (at least 2 years).

In addition, you will also require:

Excellent knowledge of ICG GCP guidelines and expertise to review and evaluate medical data.

Fluency in English.

Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.

Ability to produce accurate work to tight deadlines.

Computer literate with Microsoft Office.

Certification as a CRA needed.

Please send your cv to vera.stellino@docsglobal.com