Senior Clinical Research Associate
hace 1 mes
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.
Your responsibilities:
- Own all aspects of site management as described in the project plans;
- Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study;
- Protect 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 diligently reviewing source documents. Monitor data for missing or implausible entries;
- Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports;
- Review progress of projects and initiate appropriate actions to achieve target objectives;
- Act as a primary contact for clinical trial suppliers and other vendors;
- Own the entire process of Serious Adverse Event (SAE) reporting;
- Generate queries and resolve issues according to data review guidelines on Fortrea or sponsor data management systems.
- Education:
- Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, etc.
- In lieu of the above, a valid certification in health / life sciences by an accredited institute.
- Experience:
- Solid independent monitoring experience as CRA, with a focus on complex clinical trials (phases II and III);
- Proven experience in a variety of therapeutic areas, preferably including oncology;
- Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Italian regulatory authorities landscape;
- IT-literate, including Microsoft Word, Excel, PowerPoint, and preferably eTMF solutions such as Veeva Vault;
- Effective time management and organizational skills and a keen attention to detail;
Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders.
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.
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