Job Overview
We are seeking a dynamic and detail-oriented Clinical Research Coordinator to join our innovative research team. In this vital role, you will oversee the planning, execution, and management of clinical trials and research projects, ensuring compliance with regulatory standards and scientific protocols. Your leadership will drive the success of research initiatives that advance medical knowledge and improve patient outcomes. This position offers an exciting opportunity to collaborate across departments, manage complex data collection processes, and contribute to groundbreaking clinical studies. A passion for scientific research, excellent communication skills, and a proactive approach are essential to thrive in this energetic environment.
Responsibilities
- Coordinate and oversee all aspects of clinical trials from initiation through closeout, ensuring adherence to Good Clinical Practice (GCP) guidelines and FDA regulations.
- Supervise research staff and team members, providing guidance on study procedures, data collection, and compliance management.
- Manage research project timelines, budgets, and resource allocation to ensure timely completion of milestones.
- Collect, organize, and analyze research data accurately using appropriate statistical methods; prepare detailed reports for internal review and publication.
- Facilitate cross-functional collaboration among investigators, laboratory personnel, regulatory bodies, and external partners to ensure seamless project execution.
- Maintain meticulous documentation of study activities, regulatory submissions, grant proposals, and research administration records.
- Lead efforts in research grant funding applications, writing compelling proposals that align with project goals and organizational priorities.
- Ensure all research activities comply with internal policies, drug regulation standards, ICH GCP guidelines, and FDA requirements.
- Conduct internal communication to keep stakeholders informed about project progress and regulatory updates; support team leadership in fostering a collaborative environment.
Qualifications
- Proven supervising experience in clinical or scientific research settings with a strong understanding of clinical trial processes.
- Demonstrated expertise in clinical research methodologies, data collection techniques, and laboratory procedures.
- Experience with research data analysis, statistical analysis for research projects, and use of Microsoft Office tools for documentation and reporting.
- Strong leadership skills with a track record of leading research teams and managing complex projects effectively.
- Knowledge of drug regulation standards, FDA regulations, ICH GCP certification (or equivalent), and compliance management practices.
- Excellent written communication skills for grant proposals, research reports, and internal documentation; ability to present complex information clearly.
- Experience in research administration including grant funding processes and R&D project management is highly desirable.
- Ability to work collaboratively across departments while maintaining high standards of accuracy and integrity in all activities.
- Relevant certifications such as an ICH GCP certificate from a recognized issuer are preferred; candidates with valid CA-issued certifications will be prioritized.
Join us to be part of a passionate team dedicated to advancing scientific discovery through meticulous research coordination!
Pay: $22.00 - $23.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience:
- Clinical research or Medical Assistant : 1 year (Required)
Work Location: In person
