Clinical Research Associate
About the job
Come join our North America office!
Headquartered in Miami, 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. This is a full time, remote position, with traveling to trial sites.
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 a passion for putting your knowledge and experience to test to achieve great outcomes in a client centric solution delivery setting, Biorasi wants to talk to you now.
Job Responsibilities:
Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
Site Management Activities: Provide Project Updates to team members and project management; Confirm that Regulatory applications have been submitted and approvals received; Organize delivery of investigational product, laboratory packs, CRFs and other study specific materials to and from the clinical sites; Review study documents for compliance with protocol, ICH GCP guidelines and for Protocol Deviations/Violations and Waivers, Review study documents for subject safety events; Escalate Issues at site to project management.
Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
To lead and partake in regular team meeting / teleconferences.
Assist, as appropriate, with reporting site performance regarding timelines and deliverables the clinical project team meetings and assist with feedback information on study organization and conduct for analysis of overall study performance.
Mentoring the Associates on the subjects of job performance, trainings and professional growth.
Other duties as assigned.
Ideal Background
Bachelor Degree in biomedical sciences or related scientific discipline.
3 to 5 years monitoring or combination of clinical research coordinator and or other relevant clinical research experience.
Sound knowledge of medical terminology and clinical monitoring process.
Ability to perform regionalized travel up to 70%, depending on project need.
Excellent verbal and written communications skills.
Knowledge of FDA regulations and ICH guidelines.
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.