Clinical Trial Site Monitor – Bristol-Myers Squibb Canada
Although based out of Montreal, Janice spends most of her time in the field in Ontario and Newfoundland. She was a critical care nurse, then a research coordinator, before joining BMS in 2000. As a site monitor, Janice oversees clinical trials at various hospital and research sites. She works with nurses, coordinators and investigators to ensure that patients meet protocol inclusion criteria, correct protocol procedures are followed and GCP compliance is maintained. She reviews charts, assesses site processes and reviews test results to ensure patients continue to meet study protocol guidelines. She continues throughout the trial to assess these things and more as patient safety is always a number one concern. Janice also assists sites with any issues they may have as there may be numerous trials going on at any one time. They may be oncology trials, lupus nephritis, diabetes, rheumatoid arthritis or cardiology, just to name a few.
Some patient histories stick in Janice’s mind. She was in her second year at BMS and one site was beginning to enroll rheumatoid arthritis patients for a new biologic in early development. She read a chart of a woman in her early 30s who was practically bedridden. The woman was really struggling, so sick she couldn't care for her family. Her husband was working and was having difficulty coping. She had received numerous treatments, but nothing improved her condition for very long or she couldn't tolerate the medication. How terrible, Janice thought.
At about six months or so into the trial, Janice was reviewing the woman’s chart again and the physician had written how well she was progressing. The doctor noted she was really improving and had her life back again. During a conversation with the doctor, he informed Janice that the woman was able to care for her children and return to the workforce. One of the coordinators at the site said that the woman had told her that she finally felt whole again, that she could be a wife, mother and employee. Janice thought, “how nice that we could really help someone.”
About five years later the trial came to an end. The new medication from BMS had given the woman her life back, but she had no insurance and the treatment was not on the government formulary. Having a patient focused approach, BMS had developed a program to ensure that patients who came off the trial could continue on medication. The doctor told Janice that a great weight had been lifted off the patient’s shoulders.
Coming from a nursing background, patient well-being is always upmost in Janice’s mind. Now she can assist by helping to develop medications that help patients get a quality of life again.
Who is Janice working for? She is working for patients in need.