The Clinical Research Coordinator II independently manages and executes moderately complex clinical research studies from start up through close out. This role serves as a central operational lead, ensuring scientific integrity, regulatory compliance, and seamless coordination across investigators, sponsors, and multidisciplinary teams.
Requirements
- Develop study protocols, CRFs, and other study documents.
- Working closely with Principal Investigators (PIs) and laboratory team members.
- Technical proficiency and ability to operate, troubleshoot, and maintain specialized laboratory machinery.
- Sample preparation, including collecting, labeling, and processing biological samples for testing.
- Data management, collecting, recording, and analyzing data, often using computerized equipment.
- Keep detailed documentation of lab notebooks that document every step of an experiment. Lab maintenance, cleaning equipment, managing inventory, and handling hazardous materials.
- Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
- Collect, archive subjects’ data. Assist in scientific data dissemination. Develop, write, edit, submit and publish scientific manuscripts and present scientific abstracts at national and international conferences.
- Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.
- Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
- Complies with institution, state and federal regulatory policies, procedures, directives, and mandates.
Benefits
- Paid Time Off
- Health Insurance
- Retirement Plan
- Other Benefits