Clinical Research Coordinator/Director Of Clinical Operations Resume Example

Co-managed clinical trials of investigational drugs and medical devices focused on headache disorders, including cluster, chronic and episodic migraine. Maintained compliance with protocols covering patient care and clinical trial operations, strictly adhering to Good Clinical Practice and FDA Regulatory Requirements. Followed informed consent processes and maintained records according to IRB and regulatory guidelines, complying with all HIPAA Privacy and Security Regulations. Participated in site visits and investigator meetings and implemented trials in accordance with study timelines and budgets. Worked with fellow Clinical Research Coordinator in partnership with the principal investigator, sub investigators, monitors and sponsors to facilitate daily trial activities and ensure compliance with research protocols.

Worked to ensure our facility's processes were of superior quality and that they were financially appropriate in collaboration with my Supply Chain Team. Leaning on years of clinical and management experience, helped contribute to optimal patient outcomes through a systematic approach to review healthcare products, equipment, technology and services. Using recognized best practices, and in combination with organizational resources, evaluated appropriate utilization, clinical efficacy, and safety issues for the greatest financial value. Effectively communicated with other Senior Leadership, Infection Prevention, Employee Safety, and Nursing and co-chaired the Value Analysis Team (VAT). Implemented and managed numerous product trials and product conversions, in support of standardization, while making sure clinical needs were met.

Gathered, organized, and communicated comprehensive medication profiles after careful comparison of patient's medication orders to their pre-hospital medications, upon admission. This exhaustive list of medications included all prescription medications, herbals, vitamins, nutritional supplements, over-the-counter drugs, vaccines, diagnostic and contrast agents, radioactive medications, parenteral nutrition, blood derivatives, and intravenous solutions, as well as any known allergies. Recognizing vulnerabilities for medication errors and that interactions can occur between prescribed medication, over-the-counter medications, or dietary supplements, this reconciliation was done to avoid medication errors of omission, duplication, incorrect doses or timing, and adverse drug-drug or drug-disease interactions. The Joint Commission added medication reconciliation across the care continuum as a National Patient Safety Goal in 2005 and The Institute for Healthcare Improvement (IHI) has medication reconciliation as part of its 100,000 Lives Campaign.

Assisted with the daily operations of an active 35-bed Emergency Department (ED) that housed two Trauma Bays and a 15-bed Urgent Care, with annual patient visits averaging 49,000. Collaborated with physicians to quickly assess patients and deliver appropriate treatment while guiding nursing personnel in rapidly changing conditions. Trained new nurse graduates in proper techniques, care standards, operational procedures and safety protocols to optimize performance, safety and assurance. Oversaw and coordinated primary staffing schedules to guarantee optimum duty coverage. Worked with local ambulance service administrators to enhance relations, evaluate existing practices and provide better patient care and better patient outcomes. Maintained and assisted with the continuing education and training of all required certifications, including ACLS, PALS, TNCC, ENPC, SANE and ASLS. Served on various ED and hospital committees.