As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
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We are currently searching for In-house CRA in Hungary to be based in the office in Budapest.
Responsibilities include:
1) To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
2) To monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA.
3) To collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL
4) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits)
5) To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory, and IRB/IEC requirements.
6) To perform Case Report Form review, query generation and resolution against established data review guidelines, with or without direct supervision, on Fortrea or client data management systems, as assigned by management
7) Might be requested to work in a client facing environment as assigned.
8) General On-Site Monitoring Responsibilities per the monitoring plan.
2) To monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA.
3) To collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL
4) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits)
5) To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory, and IRB/IEC requirements.
6) To perform Case Report Form review, query generation and resolution against established data review guidelines, with or without direct supervision, on Fortrea or client data management systems, as assigned by management
7) Might be requested to work in a client facing environment as assigned.
8) General On-Site Monitoring Responsibilities per the monitoring plan.
9) To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
10) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
10) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
Requirements:
- University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology)
- Relevant clinical research experience in pharmaceutical or CRO industries
- Basic understanding of ICH-GCP guidelines
- Basic understanding of the clinical trial process
- Fluent Hungarian and English languages
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Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
www.fortrea.com
.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
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