Dynamic Principal Clinical Research Associate at Pharmaceutical Product Development LLC, adept in project site oversight and effective communication. Proven track record in risk management and clear documentation, enhancing study compliance and stakeholder engagement. Recognized for mentoring team members and streamlining processes, contributing to successful clinical trial outcomes.
Overview
21
21
years of professional experience
Work History
Principal Clinical Research Associate
Pharmaceutical Product Development LLC
10.2005 - 10.2018
Assisted in monitoring clinical trial activities to ensure compliance with protocols.
Collaborated with cross-functional teams to support study initiation and execution.
Conducted data entry and maintained accurate documentation of clinical research activities.
Supported site management by coordinating communication between clinical sites and sponsors.
Adapted quickly to new software tools for tracking study progress and participant information.
Contributed to the preparation of reports summarizing trial outcomes and findings for stakeholders.
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
Home Health Team Manager
Liberty Home Care
06.2002 - 10.2007
Led team in achieving operational efficiency through strategic planning and process optimization.
Mentored staff to enhance skills, resulting in improved team performance and morale.
Developed and implemented training programs for new hires to ensure consistency in service delivery.
Analyzed workflow processes, identifying bottlenecks and recommending solutions for improvement.
Registered Nurse
New Hanover Regional Medical Center
06.1997 - 06.2002
Utilized critical thinking skills to prioritize nursing interventions based on patients'' acuity levels and individual needs.
Conducted thorough patient assessments to identify changes in condition, promptly notifying physicians and initiating appropriate interventions when necessary.
Trained new nurses on best practices in clinical procedures, enhancing team performance and cohesion.
Streamlined medication administration processes, minimizing errors and improving patient outcomes.
Enhanced patient satisfaction by providing compassionate, holistic nursing care that addressed physical, emotional, and spiritual needs.
Assisted in the training and mentorship of new nursing staff members, contributing to a positive work environment and high-quality patient care.
Served as a preceptor for nursing students during their clinical rotations, providing valuable real-world experience and guidance to foster professional growth.
Skillfully managed challenging patient situations using de-escalation techniques, crisis intervention strategies, and therapeutic communication skills.