Ref #: 37236
Employment type: Permanent - Full-Time
Location: Home based in Germany, ideally southern part or middle of Germany.
Posted: 12-May-2022
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role:
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. ICON Global Strategic Solutions is hiring a Clinical Research Associate (m/w) to work closely with one of the most successful pharmaceutical companies. If you are a CRA in Germany willing to work home based and open for a new challenge, we would like to get to know you.
Key responsibilities:
• Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
• Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits for studies of all phases (I, II, III, IV and NIS) in a range of different indications (Focus on oncology)
• Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
• Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
• Assist in preparing sites for audits, review audit reports and contributes to resolve findings
• Build and maintain solid and long-term professional relationships with investigators and site staff
• Mentor new CRAs, as needed (experienced CRAs only)
• Travel frequency of up to 60%
To be successful in the role, you will have:
• BA/BS/BSc degree or similar
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Experience working as a CRA (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company) for at least 1 year.
• Attention to detail, organizational skills, time management & prioritization
• Relationship management & influencing skills
• Proficiency in English and German
• Willingness to travel
• Good working knowledge of common software packages
• Flexibility and Team skills
What is offered:
• 100% Home Office
• Permanent contract
• Great work atmosphere in a great team
• Mostly regional travel
• Compensatory time-off
• Contribution to pension scheme
• car allowance
• Travel time = work time
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Would you like to know more? Please submit your CV via www.ICONplc.com/FSP or nadine.rabenstein@docsglobal.com. We are looking forward to your application.
#CRAjob
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role:
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. ICON Global Strategic Solutions is hiring a Clinical Research Associate (m/w) to work closely with one of the most successful pharmaceutical companies. If you are a CRA in Germany willing to work home based and open for a new challenge, we would like to get to know you.
Key responsibilities:
• Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
• Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits for studies of all phases (I, II, III, IV and NIS) in a range of different indications (Focus on oncology)
• Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
• Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
• Assist in preparing sites for audits, review audit reports and contributes to resolve findings
• Build and maintain solid and long-term professional relationships with investigators and site staff
• Mentor new CRAs, as needed (experienced CRAs only)
• Travel frequency of up to 60%
To be successful in the role, you will have:
• BA/BS/BSc degree or similar
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Experience working as a CRA (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company) for at least 1 year.
• Attention to detail, organizational skills, time management & prioritization
• Relationship management & influencing skills
• Proficiency in English and German
• Willingness to travel
• Good working knowledge of common software packages
• Flexibility and Team skills
What is offered:
• 100% Home Office
• Permanent contract
• Great work atmosphere in a great team
• Mostly regional travel
• Compensatory time-off
• Contribution to pension scheme
• car allowance
• Travel time = work time
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Would you like to know more? Please submit your CV via www.ICONplc.com/FSP or nadine.rabenstein@docsglobal.com. We are looking forward to your application.
#CRAjob