Reports to: Clinical Research Coordinator Lead
Job Location: On-site
Job Type: Full Time
Coverage Hours: 8am - 5pm
Position Overview
Integrative Skin Science Research is seeking a motivated individual to conduct and support clinical research focused on holistic and integrative therapies as well as pharmaceutical interventions. Our research program is expanding, and we are seeking additional clinical research coordinators to join our reputable research team. The CRC will be responsible for coordinating clinical research studies from startup to close out. This candidate will work closely with Principal Investigator (PI) and Sub-investigators as well as other CRCs, Research Fellows and research assistants. Specific duties will include recruiting and screening study subjects and overseeing study visit procedures in accordance with FDA Regulations and Good Clinical Practices.
Key Responsibilities
- Organize and run clinical studies.
- Actively recruit participants; calling and following up with potential research patients, informing them about research studies, and assessing patient interest.
- Manage and perform clinical study procedures such as blood draws, maintain regulatory binders up to date, update data collection databases, and answer queries in a timely fashion.
- Perform laboratory processing as needed for study protocols and organize shipments of laboratory samples in a timely fashion.
- Maintain accurate and complete study records by FDA regulations as well as sponsor/CRO and IRB regulations and guidance.
- Communicate with study monitors and organize responses and queries to monitoring visit reviews.
- Proactively focus on clinical trial organization.
- Keep invoices up to date for studies and ensure the unit is ready for internal and external audits.
- Assist with other needs in the clinical trials unit as they arise and/or as directed by your site manager and director, and other duties as assigned.
Qualifications
- Phlebotomy training and experience with pediatric blood drawing.