Clinical/Health Care Research Coordinator
The John Paul II Medical Research Institute (JP2MRI) is a non-profit Catholic medical research organization that is seeking a part-time Clinical/Health Care Research Associate to be an integral member of the clinical and research team. The candidate will provide support for ongoing clinical services in pulmonary medicine for Pulmonary Associates and research activities consistent with the mission of the Institute. JP2MRI seeks to find cures and therapies exclusively using a variety of adult stem cells and induced pluripotent stem cells. JP2MRI develops preclinical research technologies that will broadly advance drug discovery and regenerative medicine for many diseases. In addition, the Institute engages in educational outreach to increase the number of scientists and future medical practitioners who will work with adult stem cells, always with an emphasis on medical bioethics that is consistent with Catholic healthcare guidelines.
The individual will participate in the design, planning, promotion, and control of clinical research and coordinate the processing and analysis of clinical data. Additionally, the candidate will assist in the development and maintenance of FDA regulatory procedures; Institutional Review Board (IRB) procedures; data collection and budgetary documents; and fundraising activities. Duties shall include but are not limited to:
• Screen patient for study eligibility and consent for clinical research.
• Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements.
• Communicate with principle investigator to verify patient eligibility.
• Assist in the design, development, execution, administration, and maintenance of protocols and clinical studies.
• Provide input into descriptions of complex research procedures.
• Assist patients with problems related to protocols.
• Screen, recruit, enroll, and obtain informed consent for clinical research activities.
• Oversee recruitment of subjects and scheduling of trial-related procedures.
• Participate in the collection, and entry of data into clinical research and clinical trial data systems.
• Participate in the design, development and testing of clinical research trial data systems.
• Manage and organize regulatory documents.
• Prepare regulatory submissions.
• Perform on-site audits of research and clinical data.
In addition, there will be clinical activities in pulmonary medicine that shall include part-time clinical care and 1 outreach clinic per month.
There will be no work requirements during nights and weekends and all major holidays are off.
These efforts will lead to the development of novel stem cell therapies and healthcare delivery strategies, the integration of translational research and clinical practice, and ultimately to measurable improvements in ethical regenerative medicine and vaccine programs.
The position is part-time with 25-30 hours per week with potential for full-time work.
• Bachelor's degree in Nursing (BSN) or Respiratory Therapy or an equivalent combination of education and experience is required. The position is ideal for an experienced nurse or respiratory therapist who is looking to make a career transition from clinical care to translational clinical research in regenerative medicine. Excellent written and verbal communication skills with patients/families, and interdisciplinary team members as demonstrated through written and verbal interactions are required.
• Working knowledge of Good Clinical Practice (GCP).
Applicants should send a cover letter and a resume to email@example.com.