Mavys Palacios Chang
Miami,FL
Summary
Proactive Clinical Coordinator excited to transition into a new position where superb leadership and clinical coordination abilities can be utilized. Skilled in task delegation, staff recruitment and scheduling. Committed to ensuring staff is compliant with all safety and health standards and protocols.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Lead Regulatory and Clinical Coordinator
Las Mercedes Medical Centers
06.2023 - 03.2024
- Support the creation of a new research department within a network of medical centers
- Making effective decisions when presented with multiple options for how to progress
- Creating SOPs and Training staff in all Research related requirements, GCP, OSHA, IATA, Regulatory requirements
- Following up timelines and developing strategies to maintain the expected timelines for each stage of the clinical trial
- Serving as a point of contact for teams for multiple sponsors, or a specific sponsor with multiple trials assigned to the site
- Communicating with executives from our main company, creating links between PCP and clinical staff and Research staff
- Performing quality control on the project throughout development to maintain the standards expected
- Adjusting schedules and targets on the project as needed
- Supervising enrollment and recruitment strategies to meet enrollment goals
- Experience using Real Time CTMS
- Lead Clinical Research Coordinator for several trials (Ulcerative Colitis, Epilepsy, early Alzheimer’s Disease, Diabetes Mellitus Type I and type II)
- Responsible for Resubmissions and Regulatory documentation throughout the studies
- Responsible for collecting, processing, and shipping Lab Samples and performing study related procedures (EKG, Vital signs)
- Responsible for creating Source Documents following CRF guidelines
- Creating strategies to enroll subjects that meet specific Inclusion criteria and working with CRO and Sponsors to ensure
- Mentored new clinical staff members for proper onboarding and orientation processes.
- Worked closely with clinic administrators to maintain a safe, clean and well-organized environment in which patients could receive care.
- Enhanced interdisciplinary collaboration through effective communication and coordination among healthcare team members.
- Developed strong relationships with community partners to enhance support services available for patients beyond the clinical setting.
- Ensured compliance with regulatory standards and best practices through diligent oversight of clinical procedures, documentation, and staff training.
- Coordinated, monitored, assigned, and documented patient and clinical care activities.
- Implemented new policies and educated staff on changes.
- Optimized resource allocation by regularly monitoring clinic operations and adjusting staffing levels as needed.
- Created weekly schedules for nurses, taking into account sick days and vacation time.
- Championed a patient-centered approach by actively involving patients and their families in the care planning process.
- Assessed clinical policies and procedures for compliance with changing regulations.
- Identified areas of opportunity for process improvements, leading efforts to implement changes that resulted in enhanced operational efficiency across all aspects of the clinic''s function.
- Facilitated the integration of new technologies into clinical workflows to improve patient care quality and efficiency.
- Developed and adjusted work schedules for research focused staff.
- Actively participated in policy development initiatives, drawing upon extensive knowledge of relevant guidelines, legislation, and best practice.
- Liaised with other healthcare professionals to develop comprehensive patient care plans and provide highest quality of care.
- Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to employees.
Project Manager
Clinical Pharmacology of Miami (Phase I, 120+ beds facility) - Evolution Research Group
02.2022 - 05.2023
- Delegating tasks on the project to employees best positioned to perform that task
- Making effective decisions when presented with multiple options for how to progress
- Following up timelines and developing strategies to maintain the expected timelines for each stage of the clinical trial
- Serving as a point of contact for teams for multiple sponsors, or a specific sponsor with multiple trials assigned to the site
- Communicating with executives from our main company (ERG)
- Performing quality control on the project throughout development to maintain the standards expected
- Adjusting schedules and targets on the project as needed
- Supervising enrollment and recruitment strategies to meet enrollment goals
- Experience using Real Time CTMS
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
- Met project deadlines without sacrificing build quality or workplace safety.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Identified plans and resources required to meet project goals and objectives.
- Achieved project deadlines by coordinating with contractors to manage performance.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
Clinical Research Associate (Safety monitor, CRA/CTA, IRBLeadcontact,medical coder, Pharmacovigilance)
MANARBM (CRO)
07.2018 - 01.2022
- Review, clarify and code medical diagnosis and medical treatments collected as part of the Medical History or AE, SAEs or SUSARs
- Medical coding using MedDRA and WhoDrug dictionaries
- Providing notifications and follow up to sponsors related to any AE, SAEs and SUSARs
- Open queries related to inclusion/exclusion criteria related to Medical History and or Medical Diagnosis
- Reviewing Lab Reports and Imaging Reports to alert of potential Protocol Deviations/missing data or data discrepancies as part of the safety and Medical Monitoring
- Experience with Trial Interactive Platform (eTMF, eISF), uploading and filing documents for several clinical sites
- IRB Leading contact for several clinical research sites
- Experience with Start Up process for several clinical site
- Experience with medical devices clinical trials (diagnostic devices like, blood troponin level detector on healthy patients, EKG app for Apple watch trial, Insulin pen administrator trial with Mylan)
- Working with physicians to help referred patients that meet Inclusion Criteria for specific studies and improved enrollment in studies for special populations (HIV, renal and hepatic Impaired patients)
- 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.
- Identified areas for process improvement within clinical trials, implementing changes to enhance overall project efficiency and quality.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
Medical Doctor
Consultorios Medicos
01.2009 - 06.2009
- Work as a General Family Practice doctor in a private medical facility with large population of all ages, providing primary care for any specialty and referring only if needed
- Services included X-Rays, suture, cast for simple uncomplicated fractures, treatment of sprains, strains, lower back pain, myalgias neuro myalgias
- Physical and Respiratory Therapies
- Endoscopies
- Diagnosed and treated patients suffering from chronic conditions.
- Established strong relationships with patients and their families, fostering trust and commitment to the healthcare plan.
- Teamed with other physicians, specialists, and health care providers to provide well-rounded care for complex cases.
- Interviewed patients concerning physical complaints, discussed symptoms, asked questions, and suggested treatment options.
- Met with patients to discuss medical histories and current complaints.
- Educated patients and families on benefits of healthy diet and adequate exercise.
- Ordered and executed various tests, analyses, and diagnostic images to provide information on patient condition.
- Maintained confidentiality of patient information according to federal guidelines and regulations.
- Reviewed patient allergies, problems, medications, and immunization statuses.
Medical Doctor
Cuban Medical Mission
12.2007 - 12.2008
- Work as ICU and Emergency Doctor in Venezuela as part of the Cuban Medical Mission in that country
- Seeing patients in Emergency rooms and admitting into ICU for treatment and follow up
- Services included X-Rays, suture, cast for simple uncomplicated fractures, treatment of sprains, strains, lower back pain, myalgias neuro myalgias
- Physical and Respiratory Therapies
- Endoscopies, ophthalmology care onsite
- Diagnosed and treated patients suffering from chronic conditions.
- Established strong relationships with patients and their families, fostering trust and commitment to the healthcare plan.
- Provided emergent medical care and treatment for life-threatening injuries and illnesses.
- Teamed with other physicians, specialists, and health care providers to provide well-rounded care for complex cases.
- Mentored junior physicians and medical students, fostering a supportive learning environment that promoted professional growth.
- Admitted and treated patients as part of hospital's 24-hour on-call services.
- Interviewed patients concerning physical complaints, discussed symptoms, asked questions, and suggested treatment options.
- Met with patients to discuss medical histories and current complaints.
- Educated patients and families on benefits of healthy diet and adequate exercise.
- Ordered and executed various tests, analyses, and diagnostic images to provide information on patient condition.
- Maintained confidentiality of patient information according to federal guidelines and regulations.
- Collaborated with multidisciplinary teams to develop comprehensive care plans for complex patients.
- Reviewed patient allergies, problems, medications, and immunization statuses.
- Improved patient outcomes by implementing evidence-based treatment plans and thorough followups.
- Implemented therapeutic regimens involving medications and other interventions to mitigate symptoms and prevent reoccurrence.
- Contributed valuable insights during weekly morbidity and mortality conferences that led to improvements in clinical practices across the institution.
- Implemented preventive health strategies for at-risk populations, reducing incidence of chronic diseases in the community.
- Conducted physical assessments of relevant body areas and performed standardized tests to check responses.
Education
Family Nurse Practitioner -
Miami Regional University
Miami, FL04.2024
Bachelor of Science -
Miami Regional University
Miami, FL04.2022
ICU and Emergency Medicine (Fast track training) -
Higher Institute of Medical Sciences
Havana, Cuba06.2007
Medical Doctor - Medicine
Higher Institute of Medical Sciences
Villa Clara, Cuba01.2007
Skills
- Microsoft Outlook
- Excel
- Word
- PowerPoint
- Adobe Photoshop
- EDC platforms (RAVE, Cube, Inform, Medrio)
- ESources
- Trial Interactive
- Staff Scheduling
- Clinical Leadership
- Clinical Documentation
- Developing training programs
- Process Improvements
- Patient confidentiality
- Clinical Supervision
- Infection Control
- Patient Care
- Multidisciplinary team collaboration
- Patient Education
- HIPAA Compliance
- Clinical Instruction
- Progress Monitoring
- Records Management
- Direct Patient Care
- Patient care planning
- Patient Relations
- Case Management
- Unit Administration
- HIPAA
- Informed consent
- Research coordination
- Physical assessments
- Clinical inventory control
- Clinical Quality Improvement
- Protocol adherence
- Critical Thinking
- Patient education and counseling
- Decision-Making
- Clinical Staff Management
- Basic Life Support for Health Care Providers (BLS)
- Staff Management
- Project Oversight
- Personnel Management
- Employee Work Scheduling
- Certified in CPR/AED
- Quality Control
- Care Delivery
- HIPAA Guidelines
- Patient Safety
- Staff Supervision
- Human Resources Management
- Risk Mitigation
- Risk Management
- Disease Research
- Patient Care Assessment
- Patient Advocacy
- Medication Dispensing
- Drug Inventory Management
- Facility Inspections
- Problem Identification
- Facility Oversight
- Resource Allocation
Certification
- Registered Nurse-Multistate License-2022
- Certified Clinical Research Coordinator SoCRA-2012
- GCP CITI-2012
- BLS American Heart Association-2012
- Board Certified Family Nurse Practitioner (ARNP)-Multistate-2024
Languages
Spanish
Native or Bilingual
English
Full Professional
Timeline
Lead Regulatory and Clinical Coordinator
Las Mercedes Medical Centers
06.2023 - 03.2024
Project Manager
Clinical Pharmacology of Miami (Phase I, 120+ beds facility) - Evolution Research Group
02.2022 - 05.2023
Clinical Research Associate (Safety monitor, CRA/CTA, IRBLeadcontact,medical coder, Pharmacovigilance)
MANARBM (CRO)
07.2018 - 01.2022
Medical Doctor
Consultorios Medicos
01.2009 - 06.2009
Medical Doctor
Cuban Medical Mission
12.2007 - 12.2008
Family Nurse Practitioner -
Miami Regional University
Bachelor of Science -
Miami Regional University
ICU and Emergency Medicine (Fast track training) -
Higher Institute of Medical Sciences
Medical Doctor - Medicine
Higher Institute of Medical Sciences
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