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Job Details

Clinical Study Coordinator - Freelance

Company: CROMSOURCE
Location: Italy
Reference: HQ00001368
Closing Date: 19 Jun 18
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

TalentSource Life Sciences is currently searching for an experienced Clinical Study Coordinator to join one of our partner companies, in Milan Italy.   This will be a site based, freelance position for approximately 0.2 FTE and the successful candidate will be working on studies dedicated to one client.   As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client...

Requirements:

TalentSource Life Sciences is currently searching for an experienced Clinical Study Coordinator to join one of our partner companies, in Milan Italy.

This will be a site based, freelance position for approximately 0.2 FTE and the successful candidate will be working on studies dedicated to one client.

As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your TalentSource Line Manager.

Main Responsibilities:

  • Support the Clinical Research teams with ongoing conduct of studies
  • Assist project teams with study specific documentation as appropriate:
  1. Completion of Case Report Forms (CRFs/eCRFs) and DCFs - tracking and QC
  2. Maintain drug accountability records
  3. Completion of site status reports
  • Ensure assessment and signature of documents by PI (e.g. Lab Reports, VRFs)
  • Work alongside the CRA and attend site visits, if appropriate
  • Assist in the preparation, handling and tracking of Ethics/Regulatory submissions
  • Maintain the study files and databases for the project
  • Coordinate ordering/dispatch and tracking of trial materials
  • Assist in the tracking and distribution of safety reports
  • Report activity completed via site visit report

Study Specific Tasks:

  • Assist with IRB/IEC submission
  • Collaborate with other team members to manage and submit documents for EC submission and site start up activities
  • Participating and assisting PI during SIV and monitoring visits; assist in scheduling visits and confirming dates with CRA/facility
  • Communicate with IRB/IEC
  • Liaise with CRA and study team
  • Discuss ICF with Subjects
  • Assist the PI in determining subject eligibility
  • SAE reporting transmission through safety gateway
  • Make eCRF entries/corrections/resolve DCFs
  • Maintain documentation in Investigator site file
  • Maintain subject files
  • Receipt/storage, dispensation and accountability of IP
  • Ship blood/lab samples
  • Administer subject questionnaires
  • Record AEs and concomitant medications
  • Record subject medical history
  • Perform all protocol related tasks as delegated by the PI

Requirements

  • Bachelor's degree in a scientific or related field
  • Previous experience in a similar role as a Study Coordinator or similar
  • Good knowledge of ICH-GCP and appropriate regulations
  • Possesses good communication and organizational skills
  • Proven flexibility and the ability to work under pressure
  • Computer literacy e.g. MS Word, Excel and PowerPoint
  • Proficiency in English and the local language required
  • Proactive contribution towards the team by being a flexible team player
  • Ability to work effectively both in a team and independently in a fast-paced environment
  • Excellent understanding of the Clinical Processes

Why choose TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge.

CROMSOURCE comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance. Most of our roles are permanent positions with Cromsource and you will be working on studies for just one client.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Key words: Study Coordinator, Clinical Coordinator, Clinical Research Associate, CRA, Freelance CRA, Freelance, Freelancer, Contract, Full Time, CRO, Contract Research Organization, Outsourced, Pharmaceutical, Consultant

Clinical Study Coordinator

Apply for this job: Clinical Study Coordinator - Freelance

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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