Standard Operating Procedures (SOPs) Development and Implementation
Donna Headlee, RN, BSN, CCRP
Donna Headlee, RN, BSN, CCRP, has a Bachelors of Science in Nursing and a Master’s Certificate in Regulatory Compliance. She has been with the FDA in the Center of Devices and Radiological Health since July 2004. She was with the Office of Compliance, Bioresearch Monitoring, Special Investigations Branch for approximately 5 ½ years. One of her responsibilities was coordinating and maintaining SOPs for the Division of Bioresearch Monitoring. Recently she transferred to the Office of Device Evaluation in the Program Support Office on the PreMarket Approval Staff. Prior to joining the FDA, she was a research nurse with National Cancer Institute. She was with the NCI for approximately 14 years and was responsible for coordinating Phase I oncology clinical trials. While with the NCI she initiated and coordinated the development of Standard Operating Procedures for the Division of Cancer Research. She had the honor of serving as president of SoCRA and currently serves as certification committee chair for SoCRA .
Joanne Goldberg, MSc, pht, CCRP
Joanne Goldberg, MSc, pht, CCRP, is the Assistant Director of the Canadian Institutes of Health Research’s Institute of Aging in Montreal, Canada. She holds a Master of Science degree in Biomedical Sciences from the University of Montréal as well as a Bachelor of Sciences degree in Physical Therapy from the same institution. She has been involved in clinical research for the past 18 years and has held many positions including Associate Director of Scientific Affairs, Director of Training, Director for Clinical Site Network Management, Director of Quality Management Systems, Senior Project Manager, Senior Study Coordinator, as well as Investigator. Her expertise is primarily in the development and implementation of international partnerships for health research as well as quality management systems, training in Good Clinical Practices, study methodology, and writing and implementing standard operating procedures. She is responsible for the French language translation and administration of the Society of Clinical Research Associates’ (SoCRA) certification examination and Preparatory Course. Joanne is a member of the SoCRA Certification Committee and is a Past President of the Society.