Diana Smith
Lee's Summit,MO
Overview
6
6
years of professional experience
Work History
CLINICAL STARTUP STUDY SPECIALIST
ZENOS CLINICAL RESEARCH
Dallas, TX
07.2024 - Current
- Protocol assessment: review and assess clinical trial protocols to understand the study requirements, objectives and timelines
- Regulatory compliance; ensure compliance with all applicable regulatory requirements
- Site initiation: coordinate the initiation of clinical trial sites, including obtaining necessary regulatory approvals
- Budget and Contract Management: manage and track contracts for sites
- Regulatory Submissions: prepare and submit regulatory documents
- Document management: maintain accurate and up-to-date study documentation, including protocol amendment, informed consent forms, and regulatory correspondence
- Liaison with ethics committees or IRBs to address queries, provide updates, and ensure timely approvals
- Site support: provide ongoing support to clinical trial sites by addressing their questions and concerns, resolving issues, and ensuring adherence to the study protocol
- Identify potential risk and challenges in the start-up phase and develop mitigation strategies
- Develop and manage a start-up timeline, ensuring that all activities are completed in a timely manner and accordance with the study plan
CLINICAL INTAKE SPECIALIST
UTTYLER EAST TEXAS
Tyler, TX
08.2023 - 06.2024
- Able to address substance abuse, mental health, and similar problems and implement the necessary treatment or intervention, through assessment, monitoring, and counseling
- Strong ability to maintain outstanding and positive interaction with people of diverse cultures and socioeconomic backgrounds
- Interviewing, diagnosing, and evaluating clients with problems through keen observation
- Documenting and maintaining treatment records for each client accurately
- Demonstrate the ability to effectively communicate with colleagues, supervisor, and others, including collateral agency personnel or contacts
- Listens and allows for feedback
- Exemplifying strong decision-making and problem-solving abilities as well as excellent time management, data research, and situational analysis proficiencies
- Employing advanced case management interview techniques to assess needs
CLINICAL RESEARCH COORDINATOR
BioSerenity
Rockhill, NC
01.2023 - 06.2023
- Company Overview: (Contract)
- Delivered strategic support across various clinical research functions, from administering informed consent, screening subjects for inclusion, general study oversight, technical troubleshooting, and study tracking through communication with research sponsors
- Mentored and provided instructional and highly engaging training to 5 new Clinical Research Associates, helping them achieve full proficiency within six (6) months and improving overall team productivity by 98%
- Bestowed and regulated prompt and courteous communication to maximize the relationship between the research staff and sponsors
- Successfully managed and monitored two (2) clinical trials across various therapeutic areas, ensuring 100% on-time completion and 98% adherence to ICH-GCP guidelines and protocols
- Received recognition for meeting and surpassing the goal of enrolling at least 260 subjects in the study within the 6-month period
- Instigated and oversaw the device enrollment while operating as the head liaison for over 200 participants across the U.S
- (East, West, South, and North regions) regarding the new trial, introducing a more efficient and cohesive communication and strategies to guarantee maximum data, successfully achieving a 98% completion rate
- (Contract)
CLINICAL RESEARCH COORDINATOR
CHRISTUS Trinity Mother Frances Health System
Tyler, TX
12.2022 - 02.2023
- Played a pivotal role in assuring participant safety, maintenance of informed consent, and integrity of protocol implementation, working cohesively with the principal investigator, CSV team, and sponsors to ensure productivity and timely completion of studies
- Demonstrated proficiency in using computer databases, spreadsheets and word processing software, and electronic health systems, maintaining a 97% accuracy rate and contributing to high-quality data collection for study analysis
- Restructured and improved the process of site initiation visits, reducing the average time taken by 45%, which resulted in faster enrollment for over two (2) clinical sites
CLINICAL RESEARCH COORDINATOR
Leidos Biomedical Research, Inc.
Longview, TX
07.2021 - 08.2022
- Company Overview: (Contract)
- Managed office comprised of 10+ high-performing staff on patient retention and building positive rapport during COVID-19 trials
- Optimized quick and seamless data collection, administering accurate research documentation and producing outstanding source documents per protocol guidelines and regulations, resulting in a higher rate of met deadlines and improved compliance
- Encouraged complete routine administrative tasks and patient services in a timely manner, bolstering departmental policies and procedures to ensure efficient operation of both clinical trials and direct, high-quality patient care
- Developed, verified, and implemented detailed procedures to accomplish research goals and confirm the accuracy of research data while monitoring data quality control
- Reorganized and monitored two (2) clinical trial sites, ensuring 100% protocol adherence and timely completion of study objectives
- Wrote one (1) paper detailing findings and highest standards of care spanning COVID, which were published in leading medical journals
- Identified and resolved 5+ discrepancies in clinical trial data, contributing to a 98% reduction in data query rates and ensuring accurate reporting for regulatory submissions
- Streamlined communication between 10+ cross-functional team members, reducing project timeline by 10% and increasing overall efficiency
- (Contract)
CLINICAL RESEARCH COORDINATOR
Altasciences Clinical Kansas, Inc.
Overland Park, KS
01.2020 - 04.2021
- Directed the activities of workers engaged in 5+ clinical research projects, ensuring strict compliance with protocols and overall clinical objectives to amplify the quality and integrity of practice and patient service
- Carefully and quickly assessed the eligibility of potential subjects through screening interviews, reviews of medical records, and discussions with physicians and nurses, continually exceeding assigned targets, which helped increase departmental productivity
- Participated in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
- Conducted thorough review and verification of required records, such as patient case report forms, drug dispensation records, or regulatory forms of over 200 patients, maintaining 95% accuracy, which contributed to high-quality data collection for study analysis
- Maintained contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete information and figures, resulting in improved data quality and resolution of issues within 24 hours
- Utilized an innovative approach of tracking the enrollment status of subjects and documenting dropout information, such as dropout causes and subject contact efforts, saving 10-15 hours of work time weekly
QUALITY CONTROL ASSOCIATE
Altasciences Clinical Kansas, Inc.
Overland Park, KS
04.2019 - 01.2020
- Administered quality control (QC) review of clinical trial data and facilitated the Quality Systems team with QC-related tasks, performing within compliance with the study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs)
- Ensured 100% confidentiality and maintained trial policy records and procedure materials, resulting in a increase in participation
- Recorded, tracked, and maximized the resolution of data queries to increase efficiency and reduce turnaround time by at least 25%
- Advocated a high level of quality and customer service within the department, maintaining a 98% satisfaction score
- Streamlined the documentation process for non-conformance reports, including clinical trial-related deviations, leading to a 45% reduction in processing time and enabling the team to address and resolve issues more efficiently
Timeline
CLINICAL STARTUP STUDY SPECIALIST
ZENOS CLINICAL RESEARCH
07.2024 - Current
CLINICAL INTAKE SPECIALIST
UTTYLER EAST TEXAS
08.2023 - 06.2024
CLINICAL RESEARCH COORDINATOR
BioSerenity
01.2023 - 06.2023
CLINICAL RESEARCH COORDINATOR
CHRISTUS Trinity Mother Frances Health System
12.2022 - 02.2023
CLINICAL RESEARCH COORDINATOR
Leidos Biomedical Research, Inc.
07.2021 - 08.2022
CLINICAL RESEARCH COORDINATOR
Altasciences Clinical Kansas, Inc.
01.2020 - 04.2021
QUALITY CONTROL ASSOCIATE
Altasciences Clinical Kansas, Inc.
04.2019 - 01.2020
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