Company:
Pharmaceutical Research Associates, Inc
Location: Emelle
Closing Date: 18/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Overview:
As a Clinical Research Associate (CRA) you will be dedicated to one of our global Healthcare clients who have a strong legacy of innovation and leading the way within a specialist therapeutic area. They display an ongoing commitment to changing the lives of patients and the accessibility of products in order to change the lives of those that need them.
The CRA is the primary point of contact between site staff and sponsor. This CRA will be responsible for taking leadership of site management for the selection and initiation of sites on behalf of the sponsor, as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, sponsor´s procedures and protocol requirements.
Responsibilities:
What you will be doing:
Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team
Identify potential risks and proactively take action to prevent or mitigate
Collaborate with Data Management/logistics in resolving queries
Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
Collaborate with and provide oversight of deliverables from vendors locally, if applicable
Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
Support audits and inspections at sites and affiliate, as applicable
Qualifications:
You are:
Bachelor or Master’s degree in life sciences or other relevant fields.
At least 3 years of experience as a Clinical Research Associate.
Therapeutic area knowledge and demonstrating an understanding of oncology (solid tumors) phase I studies is an advantage.
Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.
Strong analytical and communication skills with business, industry understanding and stakeholder management.
Fluent in both Italian and English.
Valid driver’s license
Why 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.
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.
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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
As a Clinical Research Associate (CRA) you will be dedicated to one of our global Healthcare clients who have a strong legacy of innovation and leading the way within a specialist therapeutic area. They display an ongoing commitment to changing the lives of patients and the accessibility of products in order to change the lives of those that need them.
The CRA is the primary point of contact between site staff and sponsor. This CRA will be responsible for taking leadership of site management for the selection and initiation of sites on behalf of the sponsor, as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, sponsor´s procedures and protocol requirements.
Responsibilities:
What you will be doing:
Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team
Identify potential risks and proactively take action to prevent or mitigate
Collaborate with Data Management/logistics in resolving queries
Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
Collaborate with and provide oversight of deliverables from vendors locally, if applicable
Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
Support audits and inspections at sites and affiliate, as applicable
Qualifications:
You are:
Bachelor or Master’s degree in life sciences or other relevant fields.
At least 3 years of experience as a Clinical Research Associate.
Therapeutic area knowledge and demonstrating an understanding of oncology (solid tumors) phase I studies is an advantage.
Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.
Strong analytical and communication skills with business, industry understanding and stakeholder management.
Fluent in both Italian and English.
Valid driver’s license
Why 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.
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.
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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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Pharmaceutical Research Associates, Inc