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Work Background
Velocity Clinical Research, Inc.Clinical Research Coordinator II
Nov. 2022 - Dec. 2023Denver, Colorado, United StatesIn addition to the CRC I experience described in UMMUNOe, as a CRC II I also: • Managed clinical trials from initiation to closeout, ensuring protocol adherence and patient safety.
• Collaborated with RNCs and PIs to review patient eligibility and source documents, enhancing study accuracy.
• Implemented strategies to improve protocol efficiency, resulting in more effective monitoring visits.
• Facilitated Quality Control and Assurance processes, contributing to high standards of clinical research.
• Developed methods to boost patient enrollment and retention, enhancing study outcomes and satisfaction.
• Boosted patient enrollment and retention by innovating engagement strategies.
• Oversaw data integrity checks, reducing error rates by enhancing reliability in trial results.
• Streamlined trial documentation processes, cutting down administrative time by 30%.
• Introduced digital tools for real-time data capture, elevating trial efficiency.
• Analyzed trial data to identify patterns, aiding in faster, data-driven decisions.
• Mentored junior staff in clinical protocol, improving team competency and output.
• Guided a team of 5 in adopting new software, boosting operational efficiency.
• Conducted in-depth statistical analysis to optimize trial resource allocation.
• Enhanced compliance by 15% through meticulous oversight of trial procedures.
• Cut operational costs by 20% through efficient management of trial resources.
• Enhanced team performance by providing continuous training on latest clinical practices.
• Monitored trial compliance, ensuring adherence to global regulatory standards.
• Reduced document retrieval times by 40% by implementing a centralized database.
• Trained 10+ new recruits in clinical research protocols, enhancing team efficiency.
• Led adoption of cloud-based systems for trial management, increasing data accessibility.
• Refined risk management protocols, decreasing protocol deviations by 18%.
IMMUNOe Health & Research CentersLead Clinical Research Coordinator
Jan. 2022 - Nov. 2022Denver, Colorado, United States• Liaised with FDA, NIH, and other regulatory bodies to ensure compliance and successful study coordination.
• Managed clinical trial processes from start-up to completion, ensuring timely data entry and resolution of queries.
• Developed tailored recruitment strategies for each study, enhancing participant engagement.
• Facilitated study procedures, including obtaining consent, processing samples, and performing ECGs.
• Oversaw study budgets and integrated invoiceable items into the RealTime CTMS portal, optimizing financial tracking.
• Streamlined study protocols to enhance process efficiency and participant compliance.
• Boosted recruitment efficiency by 30% through innovative strategy implementation.
• Mentored new coordinators, enhancing team skills and improving study outcomes.
• Pioneered advanced data analysis techniques to forecast study trends and outcomes.
• Ensured precise adherence to regulatory standards, maintaining project integrity.
• Standardized compliance documentation, reducing audit time by 20%.
Clinical Research FastrackClinical Research Graduate (BA)
Oct. 2021 - Jan. 2022Intensive Clinical Research Training covering Core Competencies including:
• ICH GCP E6 R2
• FDA Regulations 21 CFR Parts 11, 50, 54, 56
• Data Management Systems, Electronic Data Capture (EDC) systems; MedRio, Medidata, InForm
• Informed Consent Creation, Process, Execution
• Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibility and duties)
• GDP following ALCOA-C principles
• Identification and reporting AEs and SAEs
• Quality Assurance, Monitoring and Query Resolution
• Comprehension and Execution of Clinical Trial Protocols
• FDA Regulations
• Maintaining regulatory binder, housing essential documents including but not limited to 1572, Source Documents, DOA, Training Logs, ICF, SAE Forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure Manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF), and other Investigator Site Files (ISF) documents
STARLOOKS, LLC.Chief Executive Officer / Executive Assistant to Chairman
Jan. 2007 - May. 2019Greater Boston, Los Angeles, Palm Beach Area, Denver, COSTARLOOKS is a color cosmetics company with experience in invention and innovation, global manufacturing and distribution, global procurement, social media marketing and psychology, market influence, prosocial organization and much more. STARLOOKS is known for its affordable luxury, and Professional Industry standards. The STARLOOKS mission is not only to provide quality cosmetic (and other) items worldwide, but also to perpetuate a set of important principles including respect for all ages, races, sexes, cultures and genders, dignity and fidelity, integrity, ethical and moral culpability, and renowned positivity throughout our clients' and customers' lives; and just as importantly, our staff. Optimal Executive Skills: research and development, competency in client retention, sales and growth reporting, strategic planning of marketing and advertising, social media and web direction, negotiating with high stakeholders, administrative handling, staff training, creative directing, manufacturer production and retention, and customer satisfaction. Co-founded and led Starlooks, LLC, overseeing operations, hiring, and budget management.
• Acted as liaison with investors, clients, and executives, ensuring smooth communication.
• Facilitated board meetings and regulatory reviews, ensuring compliance and strategic direction.
• Conducted extensive research to support growth and problem-solving initiatives.
• Provided strategic guidance on project planning, implementation, and product development.
• Pioneered product development, leading to a 40% market expansion.
• Boosted company efficiency by 30% through strategic process reforms.
• Enhanced data analysis techniques to improve decision-making accuracy.
• Mentored 50+ staff, fostering a culture of continuous improvement and skill development.
• Implemented cutting-edge tech solutions to streamline operations.
• Spearheaded a major rebranding initiative, enhancing market presence.
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