Cra - All Levels - Sao Paulo, Brasil - Fortrea

Fortrea

Empresa verificada

Sao Paulo, Brasil

há 2 semanas

Postado por:

Ana Silva

beBee Recruiter

Descrição

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.

Essencial job duties

Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of prestudy and initiation visits; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
General On-Site Monitoring Responsibilities
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 Labcorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
Ensure audit readiness at the site level
Travel, including air travel, may be required and is an essential function of the job.
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 studyrelated 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 Labcorp or client data management systems as assigned by management
Assist with training, of new employees, e.g. comonitoring
Coordinate designated clinical projects as a Local Project Coordinator

Main requirements

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
Strong experience with Clinical Monitoring experience
Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Good planning, organization, and problem

- solving abilities

Ability to work with mínimal supervision
Good communication and interpersonal skills
Good analytical and negotiation skills
Computer competency
Fluent in local office language and in English, both written and verbal
Works efficiently and effectively in a matrix environment

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

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp 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.

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