Senior Clinical Research Associate

🕒 August 11

🐊 Florida – Remote

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⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 43%

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Logo of ClinChoice

ClinChoice

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Manage 2–3 clinical trials • Perform site management activities, including study start-up, site monitoring and closeout • Conduct on-site and remote monitoring • Keep current with scientific, regulatory and operational aspects relevant to assigned clinical projects • Assist with site selection, site evaluation, initiation visits and collection of pre-study documentation • May act as Feasibility Associate • Train site staff on study procedures • Conduct periodic monitoring visits and complete monitoring visit reports • Review Case Report Forms for accuracy, legibility, completeness and quality • Conduct source data verification and in-house clinical data review • Resolve data queries in a timely manner • Manage investigational products and trial materials • Support site safety reporting and follow-up for AEs, SAEs and SUSARs • Conduct and report study termination and archiving activities • Act as the main contact person for assigned sites • Support the Clinical Research Division with clinical data quality control • Escalate issues that may jeopardize assigned clinical projects • Report study activities and submit relevant documents to the Head of department • Develop training materials and deliver training with the Training & Qualification Management Unit • May assist with site contract negotiation and study budgets • Assist with CRF design, CRF instructions and study file organization • May support submissions, informed consent development and submission timelines • Guide and supervise CRA I staff

🎯 Requirements

• University Degree in scientific, medical or paramedical disciplines • Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines • Nursing degree or relevant degree or background preferred • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Previous experience working for a CRO is required • At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate performing on-site monitoring activities • Experience with oncology, respiratory and complex trials is required • Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements • Fluent in English and local language(s) • Proficiency in Microsoft Office, including Word, Excel and Outlook • Willingness to travel • Candidates must be willing and able to travel to investigative sites as needed

🏖️ Benefits

• Permanent employment • Fully remote work arrangement • Continuous training and professional development • Equal opportunity and diversity and inclusivity commitment

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