Senior Clinical Research Associate

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ClinChoice

WebsiteLinkedInAll Job Openings

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 and site management activities • Conduct study start-up, site selection, site evaluation, initiation, monitoring and closeout activities • Keep current with scientific, regulatory and operational aspects relevant to assigned clinical projects • Train site staff in study procedures • Conduct periodic on-site and remote monitoring visits and complete monitoring visit reports • Review Case Report Forms for accuracy, legibility, completeness and quality • Perform source data verification and in-house clinical data review • Resolve data queries in a timely manner • Manage investigational products and trial materials, including storage, inventory, dispensing records, packaging, labelling and study files • Coordinate safety issue reporting and follow-up for AEs, SAEs and SUSARs • Conduct and report study termination and archiving activities • Serve as the main contact for investigative 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 • Assist with site study budget contract negotiation after appropriate training • Assist with CRF design/development, CRF instructions and study file organization • Support project submissions, submission requirements, timelines and informed consent development • Guide and supervise CRA I staff

🎯 Requirements

• University Degree in scientific, medical or paramedical disciplines • 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 monitoring oncology, respiratory and complex clinical trials is required • Strong knowledge of clinical trial operations, GCP/ICH Guidelines and applicable regulatory requirements • Fluent in English and local language(s) • Proficiency in Microsoft Office, including Word, Excel and Outlook • Willingness to travel to investigative sites as needed

🏖️ Benefits

• Permanent employment • Fully remote position • Continuous training and professional development • Equal opportunity, diversity and inclusivity • Opportunity to work on varied studies across pharmaceutical, biotechnology, medical device and consumer health clients