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Job Details

Clinical Study Coordinator

Company: CROMSOURCE
Location: Germany
Reference: HQ00001613
Closing Date: 14 Jan 19
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

: Clinical Study Coordinator : Germany   TalentSource Life Sciences is currently searching for an experienced Clinical Study Coordinator to join one of our partner companies, in Baden Wuerttemberg Germany.   This will be a site based, freelance position for approximately 0.1 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...

Requirements:

Job Title: Clinical Study Coordinator

Location: Germany

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

This will be a site based, freelance position for approximately 0.1 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.

The Clinical Study Coordinator will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking support.

Main Responsibilities:

  • Support the Clinical Research teams with ongoing conduct of studies
  • Assist project teams with study specific documentation as appropriate:

 Completion of Case Report Forms (CRFs/eCRFs) - tracking and Quality    Control (QC)

 Maintain drug accountability records

 Completion of site status reports

  • Ensure assessment and signature of documents by Principal Investigator (e.g. Lab Reports)
  • Work alongside the Clinical Research Associate (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 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submission
  • Collaborate with other team members to manage and submit documents for Ethic Committee submission and site start up activities
  • Participating and assisting Principal Investigator during Site Initiation Visits and monitoring visits; assist in scheduling visits and confirming dates with CRA/facility
  • Communicate with IRB/IEC
  • Liaise with CRA and study team
  • Discuss Informed Consent Forms (ICF) with Subjects
  • Assist the Principal Investigator in determining subject eligibility
  • Serious Adverse Event (SAE) reporting transmission through safety gateway
  • Make electronic case report form (eCRF) entries/corrections/resolve Data Clarification Forms (DCFs)
  • Maintain documentation in Investigator site file
  • Maintain subject files
  • Receipt/storage, dispensation and accountability of Investigational Product (IP)
  • Ship blood/lab samples
  • Administer subject questionnaires
  • Record Adverse Events (AEs) and concomitant medications
  • Record subject medical history
  • Perform all protocol related tasks as delegated by the Principal Investigator

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 organisational 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

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001613

The Benefits of Working for TalentSource

  • Dedicated Line Manager
  • Monthly meetings with line manager
  • Full performance and development process with end of year reviews
  • Team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement

Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we 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. The success of these core values are evidenced by our current below industry average turnover rates.

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 experts providing experts - 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.

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

Clinical Research Associate, Clinical Study Coordinator, Freelancer, Study Coordinator, CRO, Pharmaceutical

Apply for this job: Clinical Study Coordinator

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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