Job Overview
Join our esteemed clinical team as a Clinical Research Associate, where you will play a pivotal role in executing Phase I-IV single and multi-center studies in alignment with Federal Regulations and ICH guidelines. Your expertise will assist in the planning and execution of clinical trials, significantly contributing to advancements in healthcare.
Key Responsibilities
- Collaborate with senior team members to strategize and implement study protocols
- Design and develop case report forms (CRFs)
- Select and manage Contract Research Organizations (CROs) and provide training for investigator sites
- Organize and conduct study meetings and evaluate potential new study investigators
- Write and compile submissions to regulatory bodies
- Conduct site visits including qualification, introductory, interim monitoring, and close-out visits
- Generate monitoring reports and track resolution for outstanding issues
- Ensure strict adherence to ICH guidelines, study protocols, Good Clinical Practice (GCP), and federal regulations
- Oversee the management of study documents, including Trial Master Files
- Review clinical data listings and provide feedback to management
- Ensure accountability for devices utilized during the study
Required Skills
- Extensive experience in Clinical Research Monitoring
- Exceptional attention to detail and strong organizational skills
- Proficiency in electronic data capture (EDC) or Electronic Master Files is advantageous
- Ability to multitask and meet stringent deadlines
- Strong communication and interpersonal skills
Qualifications
- 3-5 years of experience in clinical research monitoring
- Proven track record in managing clinical trials
- Solid understanding of regulatory requirements and good clinical practices
- Background in medical devices is preferred, but experience in the pharmaceutical sector will also be considered
Career Growth Opportunities
This position offers significant opportunities for professional development and career advancement within a dynamic and innovative environment. Engaging with a diverse team allows you to expand your skills and network in the clinical research field.
Company Culture And Values
We pride ourselves on fostering a collaborative and inclusive workplace that values diversity and encourages continuous learning. Joining our team means becoming part of a mission-driven organization committed to enhancing patient outcomes through innovative research.
Employment Type: Contractor