Edna Ramos
Glendale,AZ
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Trials Compliance Analyst
Phoenix Children’s Hospital
08.2023 - Current
- Identifies research operation/compliance areas to be audited, preparing audit notifications and making arrangement for conducting on-site audits
- Assesses audit responses provided by operational areas to determine appropriateness of such responses; makes recommendations for additional follow-up audits, if required
- Maintains appropriate and complete audit files
- Secures, indexes and archives all documents for storage
- Independently conducts focused investigations or special reviews into suspected/alleged research non-compliance
- Works collaboratively with other departments to obtain required documents and actively researches background information as required for special review or investigation
- Conducts interviews in a confidential and professional manner to obtain the information required for the special review or investigation
- Responds to special reviews or investigation with confidentiality, and ensuring that documentation meets standard fraud investigative techniques
- Appraises, or assists in appraising, the adequacy of corrective and preventive actions(s) taken to effectively address non-compliant conditions
- Prepares timely, thorough, clear and concise written reports of research compliance special reviews or investigations
- Arranges audit finding discussion conferences with departments/teams to present audit finding and make recommendations for corrective action plans
- Communicates effectively with researchers, administrative staff and other research workforce members to ensure a successful audit.
- Collaborated with cross-functional teams for the successful implementation of new compliance initiatives.
- Monitored adherence to industry regulations, ensuring timely reporting of any discrepancies or violations.
- Prepared documentation and records for upcoming audits and inspections.
- Served as a subject matter expert on compliance matters, providing guidance and support to colleagues across various departments.
- Developed improvement and corrective action plans to bring operations in line with requirements.
Clinical Research Associate
ICON plc
10.2022 - 08.2023
- Completed onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes
- Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out
- Verified the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations
- Ensured the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs
- Managed the investigate site staff to facilitate trial deliverables, e.g., subject enrollment data deliverables
- Verified proper management and accountability of Investigational Product (IP)
- Submitted reports of investigational site findings and updated applicable tracking systems
- Escalated observed deficiencies, issues, and corrective and preventative action plans as appropriate
- Managed essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study assists with resolution of investigational site/data queries
- Performed key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation
- Participated in audit preparation and follow-up activities as needed.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Senior Program Coordinator, Department of Surgery
Mayo Clinic Arizona
03.2021 - 10.2022
- Managed daily operations of the project
- Coordinate project related meetings between PI, research faculty and staff, and study participants
- Assisted Principal Investigator on grant applications
- Assisted study team with the protocol review process and the creation of study related research documents (e.g., project SOPs, procedure manuals, CRFs, etc.)
- Developed policies and procedures within area of responsibility
- Writes and amends protocols as necessary
- Supervised personnel and offered guidance on research methods and techniques
- Assisted in development of budgets for research projects
- Worked closely with the Surgery Residents and Research Trainees to accomplish the team goals and objectives
- Tracked project progress and updated project data in management platforms and databases
- Monitored an active list of current studies in the department and provided a monthly report on study status including accrual, budget, time to open/close and barrier to successes.
- Enhanced team productivity by providing ongoing training and support to staff members.
- Successfully secured grant funding for new initiatives by developing compelling proposals that showcased the value of the programs offered.
- Increased overall program success through continuous monitoring, evaluation, and improvement efforts.
Lead Clinical Research Coordinator, Cancer Center
Mayo Clinic Arizona
01.2015 - 01.2021
- Lead Coordinator for Health Disparities and Cancer Research projects at Mountain Park Health Center
- Accountable for the achievement of LLEAD goals, objectives, budget, and timelines
- Recruited over 3,500 minority participants for the Office of Health Disparities Research and Mountain Park
- Provided aid on grant applications
- Developed policies and procedures within area of responsibility
- Collected data and conducted data analysis
- Ensured all protocol requirements were met for each enrolled participant
- Abstracted data from necessary sources to complete the EDC and resolve queries
- Assisted with budget development for research projects
- Complied with regulatory laws and institutional guidelines
- Collaborated with community organizations for potential new research projects.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
Clinical Research Coordinator, Cancer Center
Mayo Clinic Arizona
01.2013 - 01.2015
- Study team member conducted daily CRC duties including patient study visits, patient scheduling, drug compliance and dispensing, CRF completion, IRB and regulatory submissions, and monitor visits
- Managed clinical trials in a variety of cancers including Breast, Lung, and GI cancers
- Created source documentation in compliance with the protocol and sponsor database
- Managed submission of protocol modifications and reporting of adverse events to the Institutional Review Board.
- Reduced study deviations through meticulous documentation of informed consent processes, eligibility assessments, and visit details.
- Streamlined budget development and negotiation processes to ensure adequate financial resources for clinical trials while minimizing costs.
- Boosted patient retention rates by fostering strong relationships with participants through clear communication and compassionate care delivery during study visits.
- Accelerated study completion by effectively managing clinical trial schedules and coordinating site visits.
- Supported principal investigators in developing innovative research ideas into feasible clinical protocols aligned with organizational goals.
Clinical Research Coordinator, Clinical Studies Unit
Mayo Clinic Arizona
01.2011 - 01.2013
- Study team member conducted daily CRC duties including patient study visits, patient scheduling, drug compliance and dispensing, CRF completion, IRB and regulatory submissions, and monitor visits
- Managed clinical trials in GI
- Assisted in Endoscopy suite with tissue collection for Barrett's study
- Created source documentation in compliance with protocol and sponsor database
- Managed submission of protocol modification and reporting of adverse events to Institutional Review Board.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Data Coordinator, Clinical Studies Unit
Mayo Clinic Arizona
01.2010 - 01.2011
- Abstracted clinical data from subject source documentation
- Cleaned clinical data to verify accurate
- Updated EDC following verification of subject data, including the resolution of data queries
- Performed QC audits of the clinical database
- Supported and adhere to Good Clinical Practices guidelines, FDA, institutional Review Board and HIPPA regulations
- Communicated well with the research team, Principal Investigators, Research Coordinators, and study sponsors.
Patient Service Representative
Mayo Clinic Arizona
01.2007 - 01.2010
- Worked closely with patients and physicians in Executive Health, Ophthalmology and Physical Medicine and Rehabilitation
- Managed flow of medical records
- Coordinated appointment scheduled and provided telephone support to physicians and allied health staff
- Assisted physicians with office-based procedures
- Responsibility included taking vitals and rooming patients.
Education
Bachelor of Science in Public Administration -
Northern Arizona University
Skills
- Ability to manage multiple projects at once to ensure all details are being covered
- Team player, self-starter, and the ability to work independently
- Excellent written, verbal communications skills
- Excellent organizational, prioritization and process improvement skills
- Interpersonal skills to interact with research participants
- Knowledge of Microsoft Office, Internet Explorer, Cerner, Epic
- Medical Terminology
- Bilingual Spanish Competency
- Compliance Monitoring
- Regulatory knowledge
- Compliance understanding
- Compliance Training
- Project Oversight
Certification
- Health Equity Certificate
- CITI Certification in the Protection of Human Research Subjects
Publications
- Evaluating Educational Intervention to Increase Breast Density Awareness Among Latinas: A Randomized Trial in a Federally Qualified Health Center, Ridgeway, Jennifer; Bijan, Suman, Vera; Patel, Bhavika; Ghosh, Karthik, Rhodes, Deb; Norman, Aaron, Ramos, Edna; Jewett, Matt, Gonzalez, Crystal; Hernandez, Valentina; Singh, Davinder; Sosa Miranda; Vachon, Celine, (2021). Evaluating Educational Interventions to Increase Breast Density Awareness Among Latinas: A Randomized Trial in a Federally Qualified Health Center. American Cancer Society, 2021
- Factors Predicting Unmet Supportive Care Needs among Adult Cancer Patients, Wonsun (Sunny) Kim, Ph.D.; Colter D Ray, M.A; Linda K Larkey, Ph.D.; Scott Leischow, Ph.D.; Edna Ramos; Donald Northfelt, M.D; Ruben Mesa, M.D., Kim, W., Ray, C.D., Larkey, L., Ramos, E., & Northfelt, D. (2018). Factors Predicting Unmet Supportive needs among Adult Cancer Patients. Health Behavior and Policy Review, 5 (6), 38-39, 2018
Timeline
Clinical Trials Compliance Analyst
Phoenix Children’s Hospital
08.2023 - Current
Clinical Research Associate
ICON plc
10.2022 - 08.2023
Senior Program Coordinator, Department of Surgery
Mayo Clinic Arizona
03.2021 - 10.2022
Lead Clinical Research Coordinator, Cancer Center
Mayo Clinic Arizona
01.2015 - 01.2021
Clinical Research Coordinator, Cancer Center
Mayo Clinic Arizona
01.2013 - 01.2015
Clinical Research Coordinator, Clinical Studies Unit
Mayo Clinic Arizona
01.2011 - 01.2013
Data Coordinator, Clinical Studies Unit
Mayo Clinic Arizona
01.2010 - 01.2011
Patient Service Representative
Mayo Clinic Arizona
01.2007 - 01.2010
Bachelor of Science in Public Administration -
Northern Arizona University
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