ANEICE M. ROUNKLES
West Haven
Summary
With experience in study protocols and regulatory requirements, I possess strong skills in planning and coordinating clinical research projects. Meticulously reviewing documentation and participant information, I am detail-oriented and promptly identify and resolve issues. I have proven expertise in daily operations and practices, making me accomplished and self-motivated. I effectively manage activities with a focus on current needs and future targets. Successful outcomes are driven by my exceptional project management and team leadership abilities.
Overview
8
8
years of professional experience
Work History
Clinical Research Consultant
Clinical Research Consultant
West Haven, USA
11.2022 - Current
- Input clinical research data into electronic data systems
- Creating software solutions
- Resolving issues with clinical data collection
- Ensure the study site complies with all local and federal laws and regulations
- Validating data and databases to ensure consistency and identify potential errors
- Analyzing clinical data to resolve operational issues, identifying potential safety concerns such as adverse events, and validating the research outcomes
- Monitor study sites and activities to ensure the appropriate industry protocols and terms of the study are being followed
- Preparing analytical reports
- Create thorough documentation of the study protocol and update it as needed
- Conducted root cause analysis to enhance quality and laboratory processes.
- Improved clinical trial efficiency by developing and implementing streamlined processes for data collection and analysis.
- Delivered high-quality training materials to site staff, improving their understanding of study procedures and requirements.
- Identified areas for improvement in existing processes through robust audits, leading to increased operational efficiency in subsequent studies.
- Conducted site visits to monitor clinical trial activities, promptly addressing any issues or concerns that arose in order to maintain overall study integrity.
Office Manager
ProClean of Utah
West Haven, UT
11.2022 - Current
- Implemented effective debt collection strategies, resulting in a 82% increase in collection rates
- Managed accounts receivable, reducing outstanding balances through proactive follow-up and negotiation
- Developed and maintained relationships with clients to facilitate timely payments and resolve payment issues
- Utilized data analysis to identify trends and recommend improvements in the collections process
- Implemented credit control policies to minimize financial risk and ensure compliance with industry regulations
- Collaborated with legal and finance teams to address complex debt issues and resolve disputes
- Regularly updated and maintained accurate records of customer accounts and payment statuses
- Efficiently managed daily office operations, ensuring a smooth workflow and timely completion of tasks
- Implemented and maintained organized filing systems, increasing accessibility to important documents
- Supervised and trained administrative staff, optimizing team performance and productivity
- Provided exceptional customer service when addressing client inquiries or concerns via phone calls or email correspondence.
Clinical Trials Manager
Care Access Research
Riverdale, USA
10.2020 - 09.2022
- Supports Key Sponsors and CROs
- Manages some of the site's most challenging therapeutic areas and study designs
- Monitors and mentors all levels of CRCs to ensure a complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities
- Assists Regional Site Manager and Quality Assurance Department with all Care Quality and FDA audits
- Helps assist other CRCs during their sponsor and study audits
- Develops and maintains CAPAs, when needed, with approvals from the Regional Site Manager
- Assumes CTMS superuser status and assists others to ensure accuracy, compliance, and quality input
- Monitors adequate supplies that have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)
- Ensures education of Assistant CRCs, CRC Is, site staff, and/or sub-investigators is completed for required tasks
- Contributed to successful FDA audit outcomes, maintaining accurate documentation and records throughout the study lifecycle.
- Expedited trial timelines by proactively identifying potential bottlenecks and implementing solutions to address them effectively.
- Enhanced patient safety by developing risk mitigation plans and closely monitoring adverse events during trials.
- Managed multiple concurrent trials effectively, applying strong organizational skills and prioritizing tasks appropriately to meet project deadlines.
- Fostered strong relationships with investigators, ensuring consistent communication throughout trials for smooth operations.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Maintained up-to-date knowledge of industry trends and best practices, ensuring the application of innovative techniques in trial design and execution.
- Followed informed consent processes and maintained records.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Complied with research protocols by providing ongoing quality control audits.
Clinical Research Coordinator
Alpine Research Organization
Farmington, USA
04.2019 - 10.2020
- Organized and maintained the complete records for each study, including the case reports, drug dispensation records and regulatory paperwork
- Documented adverse events and data covering side effects, conferring with investigators about reports and working with oversight agencies on management
- Screened potential subjects, reviewed medical records, and discussed histories with physicians or nurses to determine which individuals should be admitted to each study
- Coordinated efficient subject enrollment process with completely documented informed consent for each person
- Continuously monitored active studies to verify compliance with facility's protocols and regulatory standards, helping to protect personnel from legal issues
- Prepared the protocol worksheets, procedural manuals, and other study-related documentation
- Supported daily operations by completing assignments with strong focus on quality and performance
- Protected business from unnecessary liability by carefully following security and safety standards
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Complied with research protocols by providing ongoing quality control audits.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
Clinical Research Coordinator
Ericksen Research and Development
Clinton, USA
01.2017 - 04.2019
- Managed daily tasks consistently and sought out opportunities to go beyond requirements and support business targets
- Met targets consistently by working hard and with strong attention to detail
- Contributed to the successful preparation and management of the research budgets and their related monetary disbursements
- Identified problems with study protocols and worked with investigators to resolve the issues
- Carried out high-quality, detail-oriented work with little oversight
- Filed records to keep the system efficient and information organized
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
Education
Associate of Science - Health Sciences
Weber State University
Ogden, UT12.2019
Phlebotomy Certification -
Ericksen Research and Development
Clinton, UT08.2017
High School Diploma -
Roy High School
Roy, UT05.2014
Skills
- Quality Assurance
- Analytical Thinking
- Communication
- Writing
- Problem-Solving
- Self-Starter
- GCP
- Training coordination
- Investigator relations
- Site selection
- Protocol development
- Study design
- GCP adherence
- Ethics approval
- Study documentation
- Monitoring plan development
- Teamwork
- Pharmacovigilance awareness
- Teamwork and collaboration
- Problem-solving
- Time management
- Attention to detail
- Problem-solving abilities
- Multitasking
- Multitasking Abilities
- Reliability
- Excellent communication
- Organizational skills
- Team collaboration
- Team leadership
- Active listening
- Decision-making
- Relationship building
- Adaptability and flexibility
- Task prioritization
- Self motivation
- Medical terminology
- Interpersonal skills
- Analytical thinking
- Training and development
- Goal setting
- Risk assessment
- Professionalism
- Data collection
- Quality control
- Strategic planning
- Data monitoring
- Data organization
- Continuous improvement
- Quality assurance
- Audit management
- SOP development
- Data security
- Statistical analysis
- Clinical research
- Vendor management
- Logic validation
- Query generation
- Data integration
- Clinical data processing
- Database designing
- Study reporting
- Specification checking
- Form reviewing
- Access control systems
- Physical fitness
- Documentation review
- Medical device regulations
- Pharmaceutical regulations
- Waste management
- Occupational safety
- Data protection
- Environmental monitoring
- Anti-money laundering
- Trade compliance
- Ethics management
- Import regulations
- Privacy regulations
- Copyright law
- Product registration
- Source documentation
- Inventory procedure documentation
- Laboratory documentation
- Regulatory compliance documentation
- Daily receipts documentation
- Coordination of laboratory phases
- Data recording accuracy
- Safety protocols adherence
- Quality control standards
- Accurate measurements
- Patient confidentiality
- Flexible schedule
- Effective communicator
- Electronic data capture
- Informed consent process
- Adverse event reporting
- Site monitoring
- Clinical trial management
- Clinical data management
- Training and mentoring
- Therapeutic area expertise
- Patient recruitment
- Clinical study design
- IRB submissions
- Good clinical practice
- Ethics committee liaison
- Statistical data
- Laboratory safety protocols
- Critical thinking
- Effective communication
- Team building
- Safety management
- Time management abilities
- Adaptability
- Written communication
- Project management
- Problem-solving aptitude
- Research design
- Production and processing
- Cell culture
- Molecular biology
- Research management
- Ethical standards
- Source evaluation
- Research proficiency
Timeline
Clinical Research Consultant
Clinical Research Consultant
11.2022 - Current
Office Manager
ProClean of Utah
11.2022 - Current
Clinical Trials Manager
Care Access Research
10.2020 - 09.2022
Clinical Research Coordinator
Alpine Research Organization
04.2019 - 10.2020
Clinical Research Coordinator
Ericksen Research and Development
01.2017 - 04.2019
Phlebotomy Certification -
Ericksen Research and Development
Associate of Science - Health Sciences
Weber State University
High School Diploma -
Roy High School