Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world, Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies.
Biorasi hires talent and personality, not position holders. We’re a non-traditional work environment requiring only top performers. Every team member is a stock-holding owner and our culture reflects it.
Unlimited potential for professional, financial and personal growth. If you are after broad and growing responsibilities coupled with full authority, are keen on doing the job your way, without bureaucracy getting in the way of key decisions, and truly believe that a well-structured operational infrastructure is one of the key components to a company’s success, then this unique opportunity is for you.
This is a remarkable opportunity to dedicate yourself to become a vital part of a growing company in a thriving industry and benefiting professionally and financially from your accomplishments. If you have passion for achievement and are looking for a place to explore your potential, Biorasi wants to talk to you now.
The Clinical Research Associate will perform all types of site visits including Site Selection, Initiation, Monitoring, and Close-out, as well as drug accountability and other monitor activities to assure adherence to Good Clinical Practices (ICH GCP), SOPs, and study protocols. As the Clinical Research Associate you will ensure selected study sites have adequate qualification resources and facilities/equipment, have provided eligible subjects and qualified investigators.
Duties include but not limited to:
Monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with the study specific Monitoring Plan, applicable local regulations, ICH/GCP guidelines, and IRB approvals.
Ensure that Regulatory applications have been submitted and approvals received (submissions/notifications to National Health Authorities, Submission to IRB/ Ethics Committees, update submissions, e.g. protocol amendments, safety reports). Deal with Regulatory Branch for timely results.
Organize delivery of investigations product, laboratory packs, CRFs and other study specific materials to and from the clinical sites, and ensure that the Investigator receives all study documents and any updates on them.
Act as the first-line contact with Clinical Sites and report to the trial Manager on all major site related issues in an expedited manner.
AE/SAE expertise; to undertake all efforts the safety and well-being of trial subject are fully protected.
Perform review of Site Investigator File, source documents verification, retrieve Case Report Forms (CRFs) and performed query resolution in a timely manner, and follow the appropriate filing of documents in Investigator Site File and In-house Investigator Site File.
Bachelor Degree, preferably in biomedical sciences or related scientific discipline.
Prefer a minimum of 2 years monitoring experience
Thorough Knowledge of FDA regulations and ICH/GCP guidelines.
Ability to travel up to 80% and on weekends, depending on project need.
Proficiency in all MS Office programs (Word, Excel, Power point, etc.).
Excellent communication skills, both written and verbal.
Ability to multi-task, attentiveness to detail, time management.
Fluency in written and spoken English.
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.