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Clinical Research Monitor (CRA)
Lugera & Maklér spol.s r.o.
Place of work
Business travels across Slovakia and Hungary (up to 80%), Bratislava
Business travels across Slovakia and Hungary (up to 80%), Bratislava
Contract type
full-time
full-time
Start date
By agreement
By agreement
Wage (gross)
By agreement
By agreement
Information about the position
Job description, responsibilities and duties
* Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan and applicable regulatory
* Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator
* Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan
* Identify site needs, provide solutions to facilitate the clinical trial process
* Act as a primary point of contact for study sites as requested
* Assist in initial and ongoing site personnel training as required
* Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols
* Collaborates with monitoring management and study team
* Understand the study protocol and accompanying background information (e.g., Investigator Brochure, etc.)
* Possess a working knowledge of disease state and investigational product
* Possess understanding of regulatory requirements
* Ensuring Monitoring Plan requirements are being met and escalates risks
* Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator
* Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan
* Identify site needs, provide solutions to facilitate the clinical trial process
* Act as a primary point of contact for study sites as requested
* Assist in initial and ongoing site personnel training as required
* Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols
* Collaborates with monitoring management and study team
* Understand the study protocol and accompanying background information (e.g., Investigator Brochure, etc.)
* Possess a working knowledge of disease state and investigational product
* Possess understanding of regulatory requirements
* Ensuring Monitoring Plan requirements are being met and escalates risks
Employee perks, benefits
* Working for well-known international company with strong potential in Slovak Republic
* Stable job and challenging work fulfilment
* Internal package of benefits
* Continuous trainings
* Stable job and challenging work fulfilment
* Internal package of benefits
* Continuous trainings
Information about the selection process
* Please enclose your CV in English language
Requirements for the employee
Candidates with education suit the position
Secondary with school-leaving examination
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
Language skills
English - Upper intermediate (B2) or Hungarian - Upper intermediate (B2)
Other knowledge
Microsoft Excel - Advanced
Microsoft Word - Advanced
Microsoft PowerPoint - Advanced
Microsoft Word - Advanced
Microsoft PowerPoint - Advanced
Driving licence
B
Personality requirements and skills
* 2 years of experience in clinical research
* 1 year of Clinical Research monitoring experience
* Knowledge of applicable regulations (e.g. Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, etc.)
* Fluent knowledge of Slovak & English language OR Hungarian & English language
* High ethical standards
* High attention to detail and accuracy
* Excellent communication and interpersonal skills
* Ability to work effectively and gain excellent results in a cross-functional environment
* Willingness to travel up to 80% - international (Slovakia and Hungary), Driving license (B)
* Business knowledge or experience with the medical / healthcare industry
* Class III medical device and/or phase II, III and IV pharmaceutical experience
* Proficient knowledge of medical terminology
* Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)
* 1 year of Clinical Research monitoring experience
* Knowledge of applicable regulations (e.g. Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, etc.)
* Fluent knowledge of Slovak & English language OR Hungarian & English language
* High ethical standards
* High attention to detail and accuracy
* Excellent communication and interpersonal skills
* Ability to work effectively and gain excellent results in a cross-functional environment
* Willingness to travel up to 80% - international (Slovakia and Hungary), Driving license (B)
* Business knowledge or experience with the medical / healthcare industry
* Class III medical device and/or phase II, III and IV pharmaceutical experience
* Proficient knowledge of medical terminology
* Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)
Advertiser
Brief description of the company
Lugera & Maklér operates in Slovakia, Romania, Netherlands, Armenia, Poland
It's our passion to help people. Our mission statement is to constantly increase and use our ability to add value for customers, candidates, colleagues and other stakeholders!
HR services: executive search, recruitment, payroll, temporary staffing, outplacement, ACDC, trainings, conculting.
The company is a holder of a licence to offer recruitment services.
It's our passion to help people. Our mission statement is to constantly increase and use our ability to add value for customers, candidates, colleagues and other stakeholders!
HR services: executive search, recruitment, payroll, temporary staffing, outplacement, ACDC, trainings, conculting.
The company is a holder of a licence to offer recruitment services.
Number of employees
50-99 employees
ID: 1931139
Dátum zverejnenia: 18.11.2014
2014-11-18
lokalita: Bratislava Pozícia: Clinical Data Manager, Clinical Research Associate, Drug Safety Specialist, Regulatory Affairs Specialist Spoločnosť: Lugera & Maklér spol.s r.o.
Pracovná ponuka je prevzatá z inej stránky alebo zdroja.
Základná zložka mzdy (brutto) a ďalšie odmeny: By agreement