Clinical Research Associate (CRA) - Freelance

München  ‐ Vor Ort
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Beschreibung

Wir suchen für einen unserer Kunden einen Clinical Research Associate / Clinical Monitor mit mehrjähriger relevanter Berufserfahrung!

Purpose:

You will be responsible for implementing and executing the clients clinical trials in the sites assigned under his responsibility. You should ensure compliance with international guidelines, local regulations and corporate policies and procedures.

Major Accountabilities

Successfully implements and executes the clients clinical trials at their assigned sites
  • Ensures compliance with regulations, guidelines and policies for studies implemented at their assigned sites.
  • Supports budget and contract negotiation with investigational sites, as applicable, at their assigned sites; ensures payment for services.
  • Ensure recruitment strategies in place to meet study needs, including patient enrollment targets at their assigned sites.
  • Collaborates with Clinical Study Teams and within GCSM to identify and resolve site, quality or study execution issues.


Manage existing sites to meet the clients projected patient recruitment needs in their region. Works with Regional Manager to:
  • Monitor site quality and performance (metrics); develop solutions to optimize performance.
  • Monitor site availability, commitments, infrastructure and capabilities.
  • Ensure all safety issue are communicated and managed by Principal Investigator and study team in timelines appropriate to the regulatory and protocol requirements.
  • Develop and implements effective corrective action plans for all quality issues identified at assigned sites.
  • Actively participates with study team to stay current with study needs, communicating as needed with sites within defined timelines.


Maintain thorough knowledge of country regulations with special focus on regulatory requirements, guidance documents, and standards relating to global clinical trial conduct.Performs all monitoring activities according to protocol monitoring plan and relevant WIs
  • Maintain / demonstrate knowledge of the protocol, General Monitoring Guidelines (GMG), Protocol Monitoring Plan (PMP) and all protocol specific requirements
  • Executes and maintains compliance with all established the clients processes, procedures, and performance metrics.
  • With support of Regional Manager, demonstrates flexibility to meet changes in work environment and study milestones with efficiency, and with strong communication and prioritization skills.


Background

University degree in life sciences

Medical, pharmaceutical, biology, chemistry degree or Master Degree preferred

Minimum of 2-3 years related experience i.e., 2-3 years of direct regional field clinical monitoring / research.

Start: 1. Mai 2015
Projektlaufzeit: 6 Monate

Volumen: 0.7-1.0 FTE

Einsatzort: homeoffice

Zentren befinden sich in Österreich

Haben Sie Interesse an diesem Projekt? Dann freue ich mich auf Ihre Bewerbung und ein interessantes Gespräch mit Ihnen.

Viele Grüße aus München,

Stefan Blöchl

Für mehr Informationen über Progressive Recruitment, besuchen Sie www.progressiverecruitment.com
Start
05/2015
Dauer
6
Von
Progressive Recruitment
Eingestellt
03.04.2015
Projekt-ID:
879389
Vertragsart
Freiberuflich
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