Website Proxima Clinical Research, Inc.
This Jobsfunter Listing is about Proxima Clinical Research Inc in Houston, TX
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About the job
JOB DESCRIPTIONThe Safety Associate primarily handles safety report processing within the timelines outlined in the assigned projects. They also assist in development of study related documents and forms.The Safety Associate support the clinical trials with a primary focus on protecting the safety of study participants and ensuring that all safety issues are recorded and reported in accordance with the clinical trial protocol, standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable regulatory requirements.
A DAY IN THE LIFE· Participates in processing safety report activities of clinical trials as other safety related activities as assigned· Ensures work deliverables are in compliance with GCPs, Proxima and client policies and procedure, project timelines and project requirements· Works collaboratively with internal and external project teams· Assists in development of study related safety documents and forms as assigned· Functions in a key role to deliver clinical trial safety report processing on time · May participate in other study specific safety related roles as assigned
EDUCATION, TRAINING, AND PRIOR EXPERIENCE REQUIREMENTS· Experienced clinical trials professional with a science or healthcare degree.· Minimum of 5 years work experience in the clinical research/CRO/pharmaceutical industry. · Advanced knowledge of safety reporting and pharmacovigilance processes and regulatory requirements.· Demonstrate excellent attention to details, takes initiative, maintains confidentiality; ensures quality deliverables and meets project deadlines.· An in-depth knowledge and thorough understanding of FDA and ICH GCP guidelines. Preferred in-depth knowledge of EU and any other applicable global regulatory requirements that govern drug safety and pharmacovigilance and safety reporting.· Must be a demonstrated self-starter and team player with strong interpersonal skills.· Excellent communication skills and ability to work effectively with internal departments, Sponsors, vendors and personnel at clinical sites and strong written communication skills.· Technical abilities (Adobe applications, Microsoft Word, Excel and PowerPoint)· Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.· Strong problem-solving skills. · Demonstrated high level of integrity, ethics and professionalism.· Knowledge of scientific methods, research design and medical practices and procedures.· Excellent written, oral and presentation skills.
Company: Proxima Clinical Research, Inc.
Vacancy Type: Full-time · Associate
Job Location: Houston, TX
Application Deadline: N/A