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Senior CRA (SCRA)
Labcorp
Place of work
Southern Moravia Region, Southern Bohemia Region, Vysočina Region, Carlsbad Region, Hradec Králové Region, Liberec Region, Moravian-Silesian Region, Pardubice Region, Pilsen Region, Ústí nad Labem Region, Central Bohemian Region, Zlín Region, District Olomouc, Prague
Southern Moravia Region, Southern Bohemia Region, Vysočina Region, Carlsbad Region, Hradec Králové Region, Liberec Region, Moravian-Silesian Region, Pardubice Region, Pilsen Region, Ústí nad Labem Region, Central Bohemian Region, Zlín Region, District Olomouc, Prague
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
At the moment we are looking for our next Senior Clinical Research Associate to join our growing operations in Czech Republic. As a Senior CRA you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits. If you have at least 4-5 years of experience in monitoring clinical trials - we want to talk to you about this opportunity!
Position: Senior Clinical Research Associate, SCRA
Location: Czech Republic
System: home based
Responsibilities:
• Site administrating, site management and site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP;
• Registry management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
• Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
• Completing Serious Adverse Event (SAE) reporting, processing production of reports;
• Negotiating study budgets with potential investigators and assisting the legal department with statements of agreements as assigned;
• Interact with internal work groups to evaluate needs, resources and timelines;
• Assist with training, mentoring, and development of junior employees, e.g. co-monitoring;
• Assist with managing investigator site budget and other duties assigned by management;
• Assures the implementation of project plans as assigned;
• Assume line management responsibilities as assigned;
• Act in the project role of as Local Project Coordinator or Lead CRA as assigned.
Position: Senior Clinical Research Associate, SCRA
Location: Czech Republic
System: home based
Responsibilities:
• Site administrating, site management and site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP;
• Registry management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
• Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
• Completing Serious Adverse Event (SAE) reporting, processing production of reports;
• Negotiating study budgets with potential investigators and assisting the legal department with statements of agreements as assigned;
• Interact with internal work groups to evaluate needs, resources and timelines;
• Assist with training, mentoring, and development of junior employees, e.g. co-monitoring;
• Assist with managing investigator site budget and other duties assigned by management;
• Assures the implementation of project plans as assigned;
• Assume line management responsibilities as assigned;
• Act in the project role of as Local Project Coordinator or Lead CRA as assigned.
Employee perks, benefits
We Offer:
Covance's ongoing success offers team members unsurpassed growth and career development opportunities at an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package
Covance's ongoing success offers team members unsurpassed growth and career development opportunities at an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package
Information about the selection process
There is no better time to join us!
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
To apply:
To apply please go directly to Covance career site at http://careers.covance.com/ quoting the appropriate reference number - 50991BR or follow the link:
http://jobsearch.covance.com/jobs/1102513-Senior-Clinical-Research-Associate.aspx
Key words:
Clinical trial, Clinical research, research monitoring, on-site monitoring, remote monitoring, clinical operations, GCP, ICH, SOP, CRO, Senior Clinical Research Associate, Sr. Clinical Research Associate, Clinical Monitoring Associate, Clinical Trial Monitor, Clinical Research Monitor, Clinical Research Specialist, CRA II, SCRA, Senior CRA, Clinical Team Manager, Clinical Team Leader, Lead CTA, in-house monitor, in-house CRA, home based, co-monitoring, QA, Sponsor, oursourcing, insourcing, big pharma, CNS, cardiology, oncology
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
To apply:
To apply please go directly to Covance career site at http://careers.covance.com/ quoting the appropriate reference number - 50991BR or follow the link:
http://jobsearch.covance.com/jobs/1102513-Senior-Clinical-Research-Associate.aspx
Key words:
Clinical trial, Clinical research, research monitoring, on-site monitoring, remote monitoring, clinical operations, GCP, ICH, SOP, CRO, Senior Clinical Research Associate, Sr. Clinical Research Associate, Clinical Monitoring Associate, Clinical Trial Monitor, Clinical Research Monitor, Clinical Research Specialist, CRA II, SCRA, Senior CRA, Clinical Team Manager, Clinical Team Leader, Lead CTA, in-house monitor, in-house CRA, home based, co-monitoring, QA, Sponsor, oursourcing, insourcing, big pharma, CNS, cardiology, oncology
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Language skills
English - Intermediate (B1)
Personality requirements and skills
Requirements:
• University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
• Minimum 5 years of relevant clinical research experience in pharmaceutical or CRP industry for SCRA position; CRA2 experience will also be considered;
• Experience in monitoring within CNS, cardiology and/or oncology TA reqired;
• Full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements;
• Excellent site monitoring, study site management and registry administration skills;
• Ability to train and supervise junior staff;
• Ability to resolve project-related problems and prioritizes workload for self and team;
• Ability to work within a project team;
• Good planning and organization skills;
• Good computer skills with good working knowledge of a range of computer packages;
• Excellent verbal and written communication skills;
• Works efficiently and effectively in a matrix environment;
• Fluent in local and English language both in writing and speech.
• University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
• Minimum 5 years of relevant clinical research experience in pharmaceutical or CRP industry for SCRA position; CRA2 experience will also be considered;
• Experience in monitoring within CNS, cardiology and/or oncology TA reqired;
• Full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements;
• Excellent site monitoring, study site management and registry administration skills;
• Ability to train and supervise junior staff;
• Ability to resolve project-related problems and prioritizes workload for self and team;
• Ability to work within a project team;
• Good planning and organization skills;
• Good computer skills with good working knowledge of a range of computer packages;
• Excellent verbal and written communication skills;
• Works efficiently and effectively in a matrix environment;
• Fluent in local and English language both in writing and speech.
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Brief description of the company
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ID: 2018241
Dátum zverejnenia: 18.2.2015
2015-02-18
lokalita: Southern Moravia Region, Southern Bohemia Region, Vysočina Region, Carlsbad Region, Hradec Králové Region, Liberec Region, Moravian-Silesian Region, Pardubice Region, Pilsen Region, Ústí nad Labem Region, Central Bohemian Region, Zlín Region, District Olomouc, Prague Pozícia: Clinical Data Manager, Clinical Research Associate, Pharmaceutical Laboratory Technician Spoločnosť: Labcorp