- अनुभव
- 1+ वर्ष
- वेतन
- USD 54,029 – USD 89,158 / year
- उद्घाटन
- 1
- की तैनाती
- 4 पहले
- कार्य मोड
- घर से काम करें
- शिक्षा
- Bachelor's degree preferred
- फिर शुरू करना
- आवेदन करना आवश्यक है
नौकरी का विवरण
Role Overview
This opportunity involves supporting the coordination of clinical research review activities by meticulously preparing, organizing, and facilitating review meetings. The Coordinator II plays a vital role in advancing ethical research by assisting regulatory review processes and ensuring meticulous documentation standards. Working remotely with board members, internal departments, and clinical research participants, this position integrates administrative coordination, regulatory expertise, document review, and quality assurance tasks.
Key Responsibilities
- Examine research submissions to verify readiness for full board review assignments.
- Manage assignment of submissions for upcoming review sessions following established protocols.
- Inform reviewers of their assignments and updates via internal communication systems.
- Prepare meeting materials, handle post-meeting paperwork, and assist in review decision documentation.
- Conduct quality assessments of newly submitted and revised informed consent forms to ensure regulatory compliance.
- Edit consent documentation to adhere to regulatory standards, operational procedures, and specific client agreements.
- Incorporate required language and feedback from board members, clients, and internal teams.
- Perform quality control reviews of consent documentation to maintain consistency and accuracy.
- Keep updated on human subject research protections, clinical research regulations, and compliance demands.
- Complete mandatory regulatory training and organizational learning programs.
- Regularly participate in review meetings to deepen understanding of operational processes and review protocols.
- Identify and suggest process improvements to enhance workflow efficiency.
- Undertake additional tasks as directed to support the objectives of the team.
Qualifications and Skills
- At least one year of experience in IRB or clinical research with a bachelor's degree, or a minimum of four years with an associate degree; bachelor's degree preferred.
- Knowledge of human subject research regulations and guidelines is advantageous.
- Familiarity with clinical research on drugs, devices, or related healthcare studies is beneficial.
- Proficient in Microsoft Word and Outlook; working knowledge of Excel, PowerPoint, collaboration platforms, virtual meeting tools, and web-based software.
- Ability to review, edit, and proofread technical or medical documentation with precision.
- Skillful at translating complex medical or technical content into clear and understandable language.
- Excellent English communication skills, both written and verbal.
- Confident professional communication, capable of engaging effectively in meetings and discussions.
- Exceptional organization, time management, multitasking capabilities, and attention to detail.
- Ability to work independently while also collaborating effectively with remote teams.
- Willingness to learn new systems, processes, and regulatory frameworks.
Compensation and Benefits
- Competitive salary range from $54,029 to $89,158, varying by location, skills, and experience.
- Eligibility for additional variable bonus compensation.
- Fully remote work within the United States.
- Comprehensive health coverage and employee benefits.
- Paid holidays and leave entitlements.
- Opportunity to contribute significantly to clinical research and healthcare progress.
- Access to professional development, including regulatory training and ongoing education.
- Experience working within clinical research operations, regulatory compliance, and ethical review procedures.
- Collaborative environment with experienced professionals in a remote setting.
Additional Information
This position is posted on behalf of a partner company that handles all application procedures and next steps. The application selection process involves AI-assisted candidate matching but final hiring decisions rest with the hiring organization. Personal data processing follows applicable data protection laws including GDPR, with transparency and candidate rights respected.