Erika Martinez
Phoenix,AZ
Summary
Clinical research professional with an extensive background in overseeing clinical trials from initiation to close-out. Proven record in ensuring protocol compliance and managing site performance. Demonstrated proficiency in regulatory documentation and team collaboration.
Overview
15
15
years of professional experience
Work History
Senior Clinical Research Associate
Parexel
10.2024 - Current
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Set up and monitor studies, complete reports and maintain documentation, balancing sponsor generated queries and authenticated data (SDV)
- Maintain site records of research that include regulatory forms, drug dispensation records, and case reports
- Ensuing the sponsors CTP, eTMF, TMF, and LSF is up to date
- Prepare Monitoring reports while adhering to sponsors metrics
- Provide guidance and support to Clinical Research Associates (CRAs) and other team members, while mentoring junior staff and foster a culture of continuous learning
- Review and update project timelines and milestones
- Liaise with cross-functional teams (e.g., Data Management, Medical Affairs, Regulatory)
- Conduct risk assessments and implement mitigation strategies. Review site performance metrics and address any issues
- Identify process improvements and implement best practices - Participate in long-term strategic planning for the clinical operations department
- Managed project risk by identifying, quantifying and monitoring potential threats.
Senior Clinical Research Associate
ICON
04.2022 - 10.2024
- Set up and monitor studies, complete reports and maintain documentation
- Balancing sponsor generated queries and authenticated data (SDV)
- Maintain site records of research that include regulatory forms, drug dispensation records, and case reports
- Ensuing the sponsors CTP, eTMF, TMF, and LSF is up to date
- Complete SIV, IMV, COV in the west coast while adhering to the sponsor’s metrics
- Prepare Monitoring reports while adhering to sponsors metrics
- Mentor junior staff and foster a culture of continuous learning
- Review and approve monitoring reports - Ensure adherence to Standard Operating Procedures (SOPs)
- Oversee site selection, activation, and close-out processes
- Liaise with cross-functional teams (e.g., Data Management, Medical Affairs, Regulatory)
Clinical Research Associate II
IQVIA
09.2021 - 04.2022
- Monitor studies, complete reports and maintain documentation (TMF)
- Balancing sponsor generated queries and authenticate data (SDV) (RBM)
- Ensuing the sponsors CTP, eTMF, TMF, and LSF is up to date
- Complete SIV, IMV, while adhering to the sponsor’s metrics
- Site correspondence, SAE, Non- compliance while setting preventative action plans for sites
- Prepare Monitoring reports while adhering to sponsors metrics.
- 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.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
Clinical Research Associate I
ICON
01.2021 - 09.2021
- Set up and monitor studies, complete reports and maintain documentation
- Balancing sponsor generated queries and authenticate data (SDV)
- Maintain site records of research that include regulatory forms, drug dispensation records, and case reports
- Ensuing sponsors CTP, eTMF, TMF, and LSF is up to date
- Complete SIV, IMV, COV while adhering to sponsor’s metrics
- Prepare Monitoring reports while adhering to sponsors metrics
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
Clinical Research Coordinator
Mayo Clinic
11.2017 - 01.2021
- I collaborate with the research team to assess feasibility and management of research protocols, SIV, study start-up, EDC maintenance as well as IRB submissions.
- I ensure the implementation of research protocols after IRB approval and provide information as appropriate for progress reports.
- I coordinate schedules and monitor research activities and subject participation.
- I identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately.
- I provide education/training for others within the department as well as perform administrative and regulatory duties related to the study as appropriate.
- Responsible for Protocol Development and Maintenance Activities that include, ongoing management of the protocol document and process through editing, amendments, proofing, and the coordination of study logistics.
- Conduct site initiation and site qualification for future research studies.
- Lead the program development and start up, to recruit for a clinical study with Healthcare Facilities while ensuring SOPs/processes, and GCP Guideline compliance.
- Worked with the Health Equities team members to set challenging but realistic goals.
- Maintained project schedules by managing deadlines and adjusting workflow as needed.
Clinical Assistant III
Mayo Clinic
11.2016 - 10.2017
- Streamlined and developed a ordering process system within the department to improve supply ordering.
- Obtain quantitative data for various projects in the ENT department.
- Assisting in the coordination of operations supply.
- Assisting in training of the new clinical assistants.
- Ordering supplies and account of inventory/budget.
- Quality assurance with HIPAA, OSHA and risk management procedures.
- Assisting the department with processing, prescriptions, messages, and back office duties procedures.
Clinical Assistant
Mayo Clinic
06.2014 - 03.2016
- Provided a high level of support to stressed patients prior to procedures and offered them comfort and a listening ear.
- Kept an eye on supplies for both the front office and the examination rooms, restocking items several times per shift.
- Administered Urodynamic testing, bladder scans, as well as helped with various office procedures.
- Monitored patient reactions to drugs and carefully documented progress of individuals participating in clinical trials.
- Obtained vitals for a floor of 25 patients per shift.
- Achieved departmental goals and objectives by instituting new processes and standards.
Supervisor
Desert West Obgyn Ltd.
04.2010 - 06.2014
- Recruiting, hiring, orienting clinical staff.
- Coordinate/leads daily clinical operational activities/while overseeing the delivery of patient care.
- Evaluated patient care needs, prioritized treatment and maintained patient flow.
- Supported business development activities including budgets and proposals.
- Track and monitor financial aspects/review invoices and approve payments.
- Coordinated the review, revision and creation of Operational Policies within the department.
- Analyzed facility activities and data to properly assess risk management and improve services.
- Assigned staff to meet patient care needs and address productivity standards, while adjusting for census, skill mix and sick calls.
Education
MBA - Business Administration
University of Phoenix
Tempe, AZ01.2018
Bachelor of Science - Healthcare Administration Management
University of Phoenix
Tempe, AZ01.2016
Associate of Applied Science - Clinical Assistant
IIA College
Glendale, AZ01.2009
Skills
- Operations management
- Risk management
- Patient Safety
- Performance improvement
- Quality assurance
- Site management
- Report writing
- Action planning
- Site monitoring expertise
- ICH-gCP guidelines
- Documentation management
- Adverse event reporting
- Work flow planning
- Quality assurance and control
- Data Management
- Regulatory compliance
- Leadership and Team Management
- Technical Proficiency
- Therapeutic Area Expertise
Activities
- Editor, Arizona College of Healthcare Executives
- Member, Association of University Programs in Health Administration
- Mayo Clinical Bronze Quality Certification
- Super User (Epic)
Languages
Spanish
Full Professional
Timeline
Senior Clinical Research Associate
Parexel
10.2024 - Current
Senior Clinical Research Associate
ICON
04.2022 - 10.2024
Clinical Research Associate II
IQVIA
09.2021 - 04.2022
Clinical Research Associate I
ICON
01.2021 - 09.2021
Clinical Research Coordinator
Mayo Clinic
11.2017 - 01.2021
Clinical Assistant III
Mayo Clinic
11.2016 - 10.2017
Clinical Assistant
Mayo Clinic
06.2014 - 03.2016
Supervisor
Desert West Obgyn Ltd.
04.2010 - 06.2014
Associate of Applied Science - Clinical Assistant
IIA College
MBA - Business Administration
University of Phoenix
Bachelor of Science - Healthcare Administration Management
University of Phoenix
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