Tiffany Mick
Lincoln,NE
Summary
Hardworking and passionate job seeker with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Detail-oriented team player with a positive attitude.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator/Regulatory Assistant
Alivation Research
05.2024 - Current
- Implement Phase II, III and IV pharmaceutical, device, and non-interventional research trial in accordance GCP guidelines
- Recruit patients to participate in research studies, which includes explaining study design, purpose and requirements, as well as pre-screening for eligibility and answering patient questions
- Collect safety measures during patient visits, including height, weight, blood pressure, temperature, respirations, ECG and lab samples
- Process and ship lab samples
- Receive and dispense study medication
- Document all patient correspondence
- Monitor adverse events and concomitant medications
- Complete data entry and query response in a timely manner
- Assist with organizing and maintaining regulatory documents
- Submit required documents to the IRB and study sponsors
- Prepare for and assist with site-selection visits, site-initiation visits, interim monitoring visits and close-out visits
- Maintain excellent communication with the study team, sponsors and IRB
- Attend investigator meetings
Clinical Research Coordinator II
Velocity Clinical Research
05.2023 - 03.2024
- Responsible for identification, administration of, and reconciliation of IP
- Initiate and supervise return/destruction of IP, and associated responsibilities/duties
- Responsible for understanding the correct process flow, clinical administration, and documentation required for un-blinded studies as defined by individual protocols as well as the administrations of product
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines
- Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training
- Collection of regulatory documents, conducting visits, implementing new protocol amendments, providing all close out reports
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
- Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
- Ensure staff are delegated and trained appropriately and documented
- Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements
- Participated in initiation visits and investigator meetings, implementing trials following study timelines
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence
- Complied with research protocols by providing ongoing quality control audits
Investigational Product Research Coordinator
Meridian Clinical Research
08.2021 - 05.2023
- Responsible for identification, administration of, and reconciliation of IP
- Initiate and supervise return/destruction of IP, and associated responsibilities/duties
- Responsible for understanding the correct process flow, clinical administration, and documentation required for un-blinded studies as defined by individual protocols as well as the administrations of product
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines
- Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training
- Collection of regulatory documents, conducting visits, implementing new protocol amendments, providing all close out reports
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
- Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
- Ensure staff are delegated and trained appropriately and documented
- Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements
- Participated in initiation visits and investigator meetings, implementing trials following study timelines
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence
- Complied with research protocols by providing ongoing quality control audits
Child and Family Services Specialist
State of Nebraska-Division of Child and Family Services
08.2019 - 09.2021
- Promoted community resources to families, assisting them in accessing necessary services for their specific needs
- Safeguarded children's welfare through thorough risk assessments and timely interventions in high-risk cases
- Expedited permanency planning for children in foster care through diligent case management and effective collaboration with legal stakeholders
- Collaborated with multidisciplinary teams to address complex family situations and deliver comprehensive care
- Facilitated successful reunifications between children and their birth parents through consistent support and evidence-based interventions
- Identified and reported signs and symptoms of violence, abuse and neglect for immediate intervention and remediation
- Enhanced case management through regular monitoring, reviewing, and updating of individualized service plans
- Assisted parents with appointment scheduling and transportation arrangements to maintain treatment plans
- Contributed to court proceedings, advocating for family's best interests and recommending balanced solutions
- Worked with educational team to develop Individual Education Plans (IEPs) for students
Donor Center Technician/Quality Associate
Grifols Biomat Plasma Donation Center
08.2014 - 07.2015
- Increased donor satisfaction with thorough pre-donation screenings, ensuring eligibility and minimizing risks
- Maintained accurate donor records through diligent data entry and documentation efforts
- Enhanced donor experience by providing exceptional customer service and maintaining a clean, organized workspace
- Responded promptly to donor inquiries and concerns, demonstrating empathy and understanding to resolve any issues that arose
- Developed strong rapport with donors through genuine engagement, fostering long-term loyalty and increasing repeat donations
- Followed Good Laboratory Practices (GLP) consistently across daily activities and special products
- Improved product quality by implementing rigorous inspection processes and providing feedback to production teams
- Actively participated in cross-functional problem-solving sessions, leveraging expertise in quality principles as well as strong analytical skills
- Streamlined quality control procedures by developing and implementing standardized checklists for consistent inspections
- Maintained accurate records of all quality-related activities, ensuring compliance with regulatory requirements
- Performed routine equipment calibrations, ensuring accurate measurements were obtained consistently throughout testing processes
- Fixed identified issues to improve workflows
Clinical Conduct Specialist/Clinical Conduct Officer/Clinical Conduct Technician/Clinical Conduct Associate/Phlebotomist/Doser
Celerion
01.2010 - 01.2013
- Oversaw daily operations of a study specific tasks, ensuring tasks were completed efficiently and accurately
- Assisted with staff training to enforce quality, safety, and sanitation guidelines
- Evaluated staff performance and provided coaching to address inefficiencies
- Administer study specific training
- Provide leadership for conduct
- Assist Study Managers with study preparation, set up, and study meetings
Clinical Conduct Associate/Clinical Conduct Technician
MDS Pharma Services
01.2007 - 01.2010
- Demonstrated adaptability when faced with new challenges or technologies, enabling quick mastery of necessary skills
- Gathered protocol specific data using GCP such as, vital signs, ECGs, etc
- Monitored patient safety
- Maintained a safe work environment by strictly adhering to established safety protocols and guidelines
- Trained new technicians on standard operating procedures, ensuring consistency across the team
Education
CPR Certified -
American Heart Association
01.2026
State of Nebraska Certified Medication Aide -
02.2025
Bachelor of Science - Education and Human Sciences, Human Development and Family Sciences
University of Nebraska–Lincoln
Lincoln, NE05.2019
Associate of Applied Science - Criminal Justice
Southeast Community College
Lincoln03.2017
Skills
- Documentation Management
- Study Protocols
- Investigational Product Management
- Good Clinical Practices
- Standard Operating Procedures
- Pharmacovigilance
- Detailed documentation
- Electronic data capture
- ICH guidelines
- Informed consent process
- Adverse event reporting
- Patient safety
- Completing regulatory documents
- Clinical data management
- Case report forms
- Recruitment strategies
- IRB submissions
Certification
- State of Nebraska Certified Medication Aide, 02/01/23, 02/01/25
- American Heart Association, CPR Certified, 01/01/24, 01/01/26
References
- Kyle Stroh, Site Director, 308-233-1413
- Katie Osborne, Senior Project Specialist, 617-599-0625
- Valerie Houser, Unblinded Clinical Research Coordinator, 402-278-9490
- Neja Menyweather, Clinical Research Coordinator, 402-217-4767
Timeline
Clinical Research Coordinator/Regulatory Assistant
Alivation Research
05.2024 - Current
Clinical Research Coordinator II
Velocity Clinical Research
05.2023 - 03.2024
Investigational Product Research Coordinator
Meridian Clinical Research
08.2021 - 05.2023
Child and Family Services Specialist
State of Nebraska-Division of Child and Family Services
08.2019 - 09.2021
Donor Center Technician/Quality Associate
Grifols Biomat Plasma Donation Center
08.2014 - 07.2015
Clinical Conduct Specialist/Clinical Conduct Officer/Clinical Conduct Technician/Clinical Conduct Associate/Phlebotomist/Doser
Celerion
01.2010 - 01.2013
Clinical Conduct Associate/Clinical Conduct Technician
MDS Pharma Services
01.2007 - 01.2010
CPR Certified -
American Heart Association
State of Nebraska Certified Medication Aide -
Bachelor of Science - Education and Human Sciences, Human Development and Family Sciences
University of Nebraska–Lincoln
Associate of Applied Science - Criminal Justice
Southeast Community College
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