Kathy Brockett

• Led projects and analyzed data to identify opportunities for improvement.
• Followed informed consent processes per Standard Operating Procedure, documented and maintained records.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Coordinated over 75 clinical trials focused on disorders such as Multi-specialty, Cardiovascular, Asthma & Allergy, vaccine and Oncology; both device and drug.
• Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
• Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
• Oversaw start-up, operations and shutdown procedures at site level.
• Reviewed and maintained clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Collected, evaluated, uploaded and entered data into sponsor and site Electronic Medical Records in timely manner.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols. Escalated study challenges to CRA or Study Manager.
• Improved department processes through consistent hard work and dedication to Research Department flow and patient safety and implemented LEAN methods.
• Maintained compliance with protocols covering patient care and clinical trial operations.

Oversight of clinical research department. Led team to top enrolling site on asthma allergy immunology and chronic obstructive pulmonary disease trials.

• Followed informed consent processes and maintained records.
• Monitored department budget to meet Clinical Research, Office Administrator and CEO goals.
• Collected, processed, stored and shipped lab specimens.
• Worked with Principal Investigator, site coordinators and sponsors to facilitate daily trial activities and comply with research protocols.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Met department goals of keeping queries to minimum and completing all queries within 2 days and reporting SAEs to IRB and Sponsor within 24 hours.
• Collected data and followed research protocols, operations manuals and case report form requirements.
• Screened patient records, databases and physician referrals to identify prospective participants for research studies.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Coordinated clinical trials focused on disorders such as Asthma, Allergies, Immunology and Chronic Obstructive Pulmonary Disease
• Monitored patient reactions to drugs and carefully documented progress of individuals participating in clinical trials.
• Adhered to good clinical practices, operating procedures and regulatory requirements.
• Completed Protocol required tasks such as Electrocardiograms, vital signs, pulmonary function testing, injections and lab processing.