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
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
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
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
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
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
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