Dr. Fogarty"This is an incredibly dynamic environment and it's exciting to be a part of such a positive endeavor."

– Michael C. Needels, Ph.D., Chief Operating Officer

Careers

Job Opportunities
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. The Fogarty Institute offers a competitive compensation and benefits package, and is an equal opportunity employer. At this time, we are seeking exceptional candidates for the positions listed below:

For consideration, please send your resume/CV and cover letter, indicating relevant job code, to careersfogarty@fogartyinstitute.org.

Clinical Research Nurse
(Job Code 11.10.CR.C)

Responsibilities:
The Clinical Research Nurse will be responsible for implementation and on-going management of select 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, 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. Specific duties may include the following:

  • Assist in creating clinical trial protocol documents, Investigator Brochure, informed consent form, and checking these for accuracy.
  • Assess project feasibility including timelines, resources, and financial.
  • 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 will require some travel.

Requirements:

  • BS/BA in a healthcare related field, and with 5+ years experience with patient care in a clinical setting.
  • Registered nurse.
  • 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.

Clinical Data Manager
(Job Code 1.12.1.FCRI.SM)

Job Summary: The Fogarty Institute for Innovation is currently seeking a part time consultant to assist in providing Data Management and Statistical oversight. This position will support the Clinical Research Team and work closely with our Sr. Clinical Research Analyst to manage daily interactions with CROs, clients, and staff on planning, reviewing and approving CRFs, Data Management Plans, Data Standards, Data integrity and Data Reporting

Responsibilities:

  • Provide high-level experience in electronic and paper-based data management of clinical data.
  • Provide clear verbal or written information and hands-on support to project team members, CROs and contractors.
  • Manage data transfers, SAE/AE reconciliation and Med DRA coding of adverse events with CROs.
  • Support IND Reporting.
  • Support the transfer, locking, and archiving of study databases.
  • Manage scheduling and time constrains for Data Management across multiple projects.
  • Prepare new or improved processes and guidelines for data management and data flow.
  • Provide primary management, interaction and support of quality Data Management processes provided by CROs.

Qualifications and Other Required Knowledge and Skills:

  • BS/BA degree or MS/MA degree in related discipline and five + years of related experience
  • A minimum of 5 years of data management experience in Medical Device, Biotech, Pharmaceutical or Clinical Development industry.
  • Experience with electronic Clinical Database Management Systems is required and experience with electronic reporting applications preferred.
  • Knowledge of GCP and Data Dictionary Standards (e.g., CDISC) is essential.
  • Experience in cardiovascular device area is essential, with AAA experience highly desired.
  • Identifies, implements or manages a variety of complicated procedures with a wide degree of latitude to achieve efficient quality results.
  • Experience leading or managing the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
  • Demonstrate strong analytical and business communication skills.

Application Procedure: Please send your Resume and cover letter indicating relevant job code to careers@fogartyinstitute.org

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