– Michael C. Needels, Ph.D., Chief Operating Officer
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The Fogarty Institute for Innovation is a fast-paced, dynamic organization that offers talented individuals the opportunity to have a positive impact on the development of new technologies that benefit patient care.
Established in 2007, the Fogarty Institute for Innovation is a unique 501(c)(3) educational non-profit that mentors, trains and inspires the next generation of medical innovators. Led by Dr. Thomas Fogarty, one of America's most prolific biomedical innovators, the Fogarty Institute has created an environment conducive to nurturing the creative process where physicians and engineers learn to collaborate and understand the integration of their respective fields. In this way we are catalyzing the development of technological breakthroughs that hold the promise of significantly benefiting patient care.
In 2010 the Fogarty Institute embarked on an exciting new opportunity with the addition of a Clinical Research team. This team supports the Institute's educational and innovation activities by working closely with El Camino Hospital on Clinical Research. The FCRI team will provide clinical trial management services to both sponsor and investigator-initiated clinical trials, and these services include contract negotiation, IRB submission, patient recruitment, trial protocol/procedures management, budget tracking, and billing.
We are now looking for a few select individuals to join this team, and participate in the application of cutting-edge technology to address human health needs. If you have experience in Clinical Development and are interested in a collaborative dynamic work environment where developing a personal rapport with highly regarded medical experts and gaining early access to new treatment modalities for patients drives you, then we may have an opportunity for you. We are seeking bright, hardworking, considerate, and talented individuals who are critical, analytical thinkers with a keen sense of ethics and are committed to ensuring patient welfare.
The Fogarty Institute offers a competitive compensation and benefits package, and is an equal opportunity employer. Application Procedure: Please send your Resume and cover letter indicating areas of expertise to email@example.com
Clinical Research Nurse/Coordinator(Job Code 04.14.1.FCRI.N)
Job Summary: The Clinical Research Nurse/Coordinator will be responsible for implementation and on-going management of select oncology related clinical research trials in accordance with the code of federal regulations and Good Clinical Practices (GCP). Primary responsibility will include interacting with patients and physicians, site preparations, screening and enrollment of research subjects, adherence to study protocols and ensuring necessary data is collected/reported in the appropriate source documents/CFR’s, assisting investigators with study subject visits, and accountability for test articles. This individual also serves as the primary contact between study site and sponsor/monitor organizations.
Responsibilities: Specific duties may include the following tasks:
- Assist in evaluating protocols for feasibility including reviewing materials, such as the Investigator Brochure and informed consent form for accuracy
- Assess project resource requirements including people, physical space, materials
- Prepare the site for conducting the study including creating and reviewing study-specific source documents and other study-related materials
- Facilitate communication between all parties involved in the research process
- Facilitate positive interactions with patients and physicians
- Design and organize study files, and disseminate information as necessary/required
- Prepare documents for submission to the Institutional Review Board (IRB)
- Assist with recruiting, contacting and screening potential subjects for approved studies
- Ensure that all necessary data are gathered and recorded in the appropriate source documents and with case report forms
- Work with sponsor monitors during monitoring visits
- Investigate and resolve any data queries
- Ensure that study documents are complete, current and filed correctly
- Manages laboratory procedures including processing, packaging and shipping to core labs
- Complete study closeout activities at the end of the study
- This position may require limited travel
Qualifications and Other Required Knowledge and Skills:
- BS/BA with a healthcare related field with 5+ years experience and/or solid background in nursing
- Knowledge of Microsoft Office systems, especially MS Word and MS Excel
- Familiarity with GCP’s, Regulatory and Medical Monitoring Guidelines
- Excellent organizational skills. Able to execute multiple tasks in a fast-paced, changing environment, with ability to pay special attention to details
- Ability to communicate effectively and efficiently
- Able to work well with others and be dependable and proactive. Constructive approach to problem solving while balancing events and data demands
- Comply with company policies and applicable laws
- Required to read and understand company policies, complete required training as necessary; ability to seek clarification when questions arise, and keep up with changes as roles and responsibilities evolve
Please send your Resume/CV and cover letter indicating relevant job code to firstname.lastname@example.org