Clinical Coordinator/Technical Writer
275 N. Gateway Dr. Phoenix, AZ 85034
VisionGate produces the Cell-CT™, the world’s first 3D cellular imaging device based upon optical projection tomography, which renders cells with sub-micron, isometric resolution. Based on 3D images of cells from sputum, VisonGate aims to improve patient health with the world’s first, non-invasive, diagnostic test for early lung cancer detection: LuCED™. VisionGate is expanding its team in Phoenix that will carry the development and commercialization of its products forward.
VisionGate is currently commercializing its LuCED test for early detection of lung cancer. We are also partnering with several institutions locally and internationally who will supply study specimens that will be used to evaluate the LuCED test. Development of other tests based on the Cell-CT are being considered or are in progress. To facilitate our development and clinical programs we seek to add a staff member who will coordinate these clinical studies. Responsibilities will also involve creation of clinical study protocols and reports, abstracts for publications, and other documentation required in a regulated environment. The position will report to the VisionGate CTO and may develop into a management role. Some travel may be required.
Roles and Responsibilities
- Identify clinical sites who could supply VisionGate with specimens for its development and clinical programs.
- Coordinate work with clinical sites that supply specimens for trials of VisionGate tests.
- Maintain clinical study files.
- Maintain inventory of specimens.
- Insure commitments made in protocols have been fulfilled.
- Aid writing study protocols.
- Aid writing test reports and publications.
Training and Experience
- BS in biology or other science-related major.
- 5 years experience as a clinical study coordinator.
- 2-3 years experience as a technical/clinical writer.
- Status as an author in a peer-reviewed journal desired.
- Excellent oral communications skills.
- Familiarity with CLIA regulations.
- Familiarity with FDA GCP and HSP regulations.
- Experience with operation in an FDA regulated environment.
To apply contact Michael Meyer, email@example.com