Experienced Clinical Professional with a strong background in Clinical Research. Over fifteen years of managing and implementing Good Clinical Practices. With a deep understanding of adult learning principles, clinical procedures, as well as teaching and evaluation methodologies. Noteworthy for promoting evidence-based practices, improving patient outcomes, and fostering interdisciplinary collaborations within medical teams. Committed to continuous professional development and staying current with emerging trends in a clinical environment.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Clinical Educator
Covenant Metabolic Specialist
Bradenton, FL
06.2024 - Current
Developed, implemented, and evaluated training programs to ensure staff are meeting the standards of quality and safety in patient care
Conducted assessments of staff skill level and provided feedback to improve their competency.
Facilitated orientation sessions for new hires to introduce them to the clinical environment and policies.
Created lesson plans based on current evidence-based practices that were tailored to meet individual learning needs.
Mentored clinicians as needed throughout their onboarding process with the organization.
Developed strategies for measuring effectiveness of training programs through pre and post tests or other methods.
Prepared reports summarizing results from trainings or other activities related to clinical education.
Clinical Operations Manager
Synergy Healthcare
Bradenton, FL
10.2021 - 05.2024
Developed and implemented clinical operations processes to ensure compliance with regulatory requirements.
Coordinated the development of clinical protocols, informed consent forms, case report forms, and other study documents.
Managed the recruitment process for clinical research studies, including identifying potential sites and investigators.
Monitored site performance to ensure adherence to Good Clinical Practices guidelines.
Conducted regular audits to verify accuracy of data collected from clinical sites.
Provided guidance on budgeting for clinical trials and managed budgets accordingly.
Ensured timely delivery of essential documents related to clinical research studies such as CRFs and SOPs.
Collaborated closely with internal teams such as Regulatory Affairs, Quality Assurance, Data Management, Biostatistics, and Medical Writing to ensure successful execution of research projects.
Coordinated meetings between external vendors and partners involved in the conduct of a study.
Oversaw daily activities and interactions with patients.
Managed clinical operations and procedures and enforced adherence to federal and state regulations and healthcare law requirements.
Clinical Research Associate
Actalent
Saint Petersburg, FL
07.2019 - 10.2021
Conducted site initiation visits and monitored ongoing studies at investigator sites.
Assessed incoming source documentation for accuracy and completeness against case report forms.
Provided support in writing informed consent forms, patient diaries, study manuals.
Ensured proper storage of investigational product at investigator sites per GCP guidelines.
Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
Adhered to good clinical practices, operating procedures and regulatory requirements.
Performed pre-study, closeout and interim visits to check on study activities.
Clinical Research Coordinator II
Emory University - Winship Cancer Institute
Atlanta, GA
06.2008 - 06.2019
Developed and maintained accurate and timely study databases.
Assisted in the preparation of Institutional Review Board submissions for clinical trials.
Performed patient assessments, collected and analyzed data, and prepared reports.
Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
Reviewed medical records for accuracy of source documentation prior to database lock.
Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
Prepared informed consent forms for review by ethics committees.
Provided training to study staff on protocol requirements and GCP regulations.
Supervisor of Medical Oncology
Emory Healthcare Winship Cancer Institute
Atlanta, GA
10.2003 - 06.2008
Directed and supervised team of 15 employees in daily operations.
Developed and implemented operational policies and procedures to ensure efficiency and accuracy of workflows.
Maintained accurate records of employee performance, attendance, leave requests, and disciplinary actions.
Resolved customer complaints in a timely manner while ensuring customer satisfaction.
Conducted weekly meetings with team members to discuss upcoming tasks and project deadlines.
Recruited, hired, trained, mentored, coached, evaluated, and terminated staff as necessary.
Assisted in creating budgets for departmental expenses including personnel costs.
Ensured compliance with workplace safety regulations by providing training sessions for all staff members.
Monitored employee productivity levels on a regular basis to identify areas of improvement.
Evaluated employee performance through periodic reviews and documented results accordingly.
Provided guidance and direction to subordinates regarding job duties and responsibilities.