Helen Darwin, BS, CCRP, President

Helen Darwin, President, is a Certified Clinical Research Professional; highly experienced in both industry and healthcare environments for Phase I to Phase IV local, investigator initiated and multi-centre clinical trials. Helen is past president of the Society of Clinical Research Associates (SoCRA).

Throughout her extensive career in clinical research, Helen Darwin has built a solid reputation for the highest industry standards and for professional excellence.

Helen’s experience includes 7 years as a senior site manager with Johnson & Johnson (Janssen-Ortho Inc). In this role she performed Site Assessments, Initiation Visits, Training, Routine Monitoring, and Site Close-out visits. She was responsible for training new CRAs and contract monitors in her region. She represented J&J during site audits and at international investigator meetings.

Helen developed and presented a highly successful training program for study coordinators across Canada on behalf Johnson & Johnson (J&J). She continues to enhance this program and is now a SoCRA course leader and presenter for many continuing education programs throughout Canada and the US. Prior to J&J, Helen worked as a clinical research associate for an international Contract Research Organization. Before joining industry, she was a study coordinator for five years, working primarily in the area of phase I to IV oncology trials.

Throughout her career, Helen has provided protocol and GCP expertise for the management of numerous therapeutic areas including Oncology, HIV/AIDS, Cardiovascular, Infectious Disease, Endocrinology, Orthopedics, Renal Dialysis, Gastro-Intestinal, Genito-Urinary, Plastic Surgery, Medical Devices, and CNS.