Program Goals and Objectives
The Dermatology Clinical Research Fellow Program at New York Presbyterian Hospital, Columbia University Medical Center Campus provides an in-depth experience in the clinical research related to Dermatology.
The goals of the fellowship are:
- To develop skills in the planning, implementation and conduct of clinical trials
- To develop skills in the evaluation, management and prevention of dermatologic diseases, and data analysis
- To gain experience with these diseases in the clinical research (practice) setting
- To develop effective interpersonal and communication skills with study patients, their families, members of the research staff, and pharmaceutical sponsors in the clinical research setting
- To become familiar with regulations at the Federal and State level that govern current approaches and tools for conducting clinical trials
- To develop an understanding of the drug development process, and Good Clinical Practices
The Columbia University Department of Dermatology Clinical Research Fellow Program offers clinical research experience tailored to the needs of the fellow. Working with academic clinicians, the fellow will gain clinical skills that will serve them and their patients in the future. The fellow will be under the tutelage of Dr. Julian Mackay-Wiggan.
The clinical fellow is expected to productively participate in the clinical research activities of the Department of Dermatology, is expected to publish at least one clinical research article during their fellowship and is expected to make at least one scientific presentation.
Following is a comprehensive, although not all inclusive, list of responsibilities during the 1 year:
- Assist in all daily activities and monitoring of clinical trials, involving government agencies, pharmaceutical industry and investigator-initiated clinical trials ensuring compliance with Good Clinical Practices
- Act as sub- investigator for all departmental clinical trials
- Assist in recruitment and screening of study patients
- Obtain written informed consent for each study patient and obtain HIPAA authorizations
- Perform the following list of procedures:
- Physical examinations
- Skin evaluations
- Determine body surface area affected and utilize validated skin assessment tools (e.g. Psoriasis Area Skin Index [PASI], Eczema Area Skin Index [EASI]) under supervision
- Perform shave and punch biopsies under supervision
- Perform electrosurgery under supervision
- Perform potassium hydroxide microscopic examination for fungi, patch testing, and phototherapy under supervision
- Administer study medications (e.g. intramuscular, intravenous, subcutaneous)
- Take medical photographs
- Monitor study patient’s safety and drug efficacy
- Monitor and report all adverse events
- Assist in writing investigator-initiated protocols
- Assist in preparation of proposals to be submitted to our local IRB
- Assist in preparation of manuscripts for publication in medical journals
- Present study-related information at monthly departmental meeting, at pharmaceutical meetings and at national medical meetings
- Fellow is expected to have a broad-based knowledge of biomedical, clinical, and research aspects of medicine and to demonstrate the application of this knowledge to activities within the research unit.
- Fellow is expected to develop strong interpersonal and communication skills that maximize the effectiveness of their professional relationships with research patients, their families, and other members of the research staff.
- Fellow is expected to acquire behavior that reflects a commitment to continuous professional development, ethical practice, and an understanding and sensitivity to diversity and a responsible attitude toward their research patients.
- Fellow is expected to demonstrate an understanding of the drug development process and Good Clinical Practices.
Fellow SupervisionJulian Mackay-Wiggan, M.D., M.S. is the Director of the Clinical Research Unit. Carol Coppola, R.N. is the Clinical Research Unit Coordinator and Manager. The Director and the Research Coordinator will assist and supervise the fellow in the acquisition of knowledge related to developing protocols for clinical research studies and utilizing methodology for measurement of clinical indicators, the proper conduct of observational and randomized clinical trials, and the appropriate data management.
- MD Degree
- 2 letters of recommendation
- Scores from the USMLE Steps 1 and 2
- USMLE Step 3 (required to obtain New York State Medical License, which must be obtained prior to start of fellowship)
- New York State Medical License prior to the start date of the fellowship (July 1)
Mandatory completion of the following courses for Columbia University Medical Center Research to be done at Columbia at the beginning of the year:
- Health Sciences: Protection of Human Research Participants (GCP) – for Patient-Oriented Clinical Investigators
- HIPAA: Health Insurance Portability Accountability Act Training Course
- Conflict of Interest Statement
Graduate Medical Education Checklist
- BLS/ACLS Training
- Infection Control and Barrier Protection
- Identification and Reporting of Child Abuse in New York State
- MRI Safety Training (NYPH)
- Risk Management Training (NYPH)
- Medication Reconciliation Course (NYPH)
- Annual Hospital Training (NYPH)