CRA - Senior CRA, southern Poland

Poland Job Openings

Fortrea

FULL TIME

October 18, 2024

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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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.

We are recruiting for CRA or Senior CRA based in Krakow/ Katowice/ Wroclaw for a permanent and full-time contract. Our positions offer excellent exposure to a range of disease areas and a real opportunity for career progression and promotion in time.

Responsibilities include but are not limited to:

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; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plan
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
Monitor data for missing or implausible data
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines
Ensure audit readiness at the site level
Prepare accurate and timely trip reports
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Participate in and follow up on Quality Control Visits (QC) when requested
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
Might be requested to work in a client facing environment
Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
Assist with training, of new employees, e.g. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Education and Qualifications:

We are searching for a university graduate with a life science degree or nursing background who relishes working in a fast paced environment, on complex and demanding protocols.

If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.

Minimum 3 years of independent monitoring experience in international Pharma/CRO company
Experience in Oncology preferred but not a must; although you should be willing to work on Oncology studies
Excellent understanding of Serious Adverse Event (SAE) reporting
Fluent in English and Polish

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:

For more information about how we collect and store your personal data, please see our

Privacy Statement

We regret to inform you that this job opportunity is no longer available as it has expired

New Job Alerts

KPMG Poland

Senior Tax Consultant - Tax Kraków

Kraków

November 15, 2024

View Job Description

KPMG Poland

Executive Consultant - Financial Services - Actuarial Advisory

November 15, 2024

View Job Description

Toyota Motor Manufacturing Poland

Specjalista / Starszy Specjalista (m/k) w obszarze Biznes Partneringu

Wałbrzych

November 15, 2024

View Job Description

KPMG Poland

Consultant / Junior Consultant - Financial Services - Credit Risk

November 15, 2024

View Job Description

SpektrumWork24

Wsparcie dla samotnie mieszkającego Seniora

FULL TIME

September 18, 2024

View Job Description

November 15, 2024

View Job Description

SentinelOne

Enterprise Sales Representative (Poland)

November 15, 2024

View Job Description