Data Management Clinical Trials
Resume:
CONNIE LANDON
Port Hueneme CA 93041
**************@*****.***
Professional Summary
Clinical coordinator with over 15 years of experience in managing multiple clinical
regulatory processes, and patient care coordination. Demonstrate expertise in FDA regulation GCP, and NIH guidelines with strong proficiency in data management and budget negotiations. Skilled in keeping compliance and ensuring timely execution of clinical trials.
Advanced knowledge of medical terminology and patient confidentiality
PROFESSIONAL ACHIEVEMENTS
Clinical Research Coordinator 12/12-Present
Facilitated cross-departmental communication for patient visits, improving protocol adherence and enhancing patient enrollment rates.
Provided guidance to junior staff on research processes, nurturing a collaborative environment that emphasized knowledge sharing and professional development.
Coordinated multi-center clinical trials, ensuring compliance with GCP and FDA regulations, leading to timely completion of studies and enhanced patient safety.
Collaborated with multidisciplinary teams to streamline patient recruitment processes, enhancing enrollment rates and expediting trial timelines.
Maintained precise regulatory documentation and managed IRB submissions, ensuring all trials adhered to local SOPs and regulatory standards.
Fostered strong relationships with PIs and sponsors, advocating for budget allocations that supported research objectives and optimized resource utilization.
Coordinated multi-center clinical trials, ensuring timely regulatory submissions and achieving substantial improvements in study timelines.
Implemented comprehensive data management systems, enhancing compliance tracking and facilitating smoother data entry processes.
Fostered collaboration among research teams, ensuring all project tasks were completed accurately and on schedule, enhancing team morale.
Maintained rigorous oversight of regulatory documents, ensuring adherence to GCP and FDA regulations while minimizing compliance risks.
Coordinated multi-center clinical trials, ensuring compliance and timely execution, leading to increased study enrollment and participant engagement.
Analyzed regulatory submissions and maintained meticulous protocol documents, achieving seamless approvals and enhancing trial efficiency.
Oversaw daily operations of research studies, streamlining processes to optimize team performance and meet critical project deadlines.
Implemented data management systems using Medidata Rave and RedCap, resulting in measurable improvements in data accuracy and accessibility.
Collaborated with Principal Investigators to review patient eligibility and consent, fostering a supportive environment that prioritized participant safety.
Data Manager 8/06- 11/12
Reviewed and processed data from Phase 1-3 trials, leading to substantial improvements in reporting efficiency and regulatory compliance.
Maintained patient confidentiality and adherence to research protocols, safeguarding participant integrity and study reliability.
Worked closely with study monitors to streamline data collection processes, fostering improved communication and project cohesion.
Utilized strong organizational skills to provide comprehensive support across multiple clinical trials, ensuring timely and accurate data management.
Collaborated with clinical teams to maintain patient confidentiality, ensuring compliance with ethical standards and fostering trust in the research process.
Executed thorough data entry and management using Rave, InForm, and RedCap, ensuring accuracy in research records and documentation.
Developed streamlined data collection protocols, significantly reducing data processing time and improving overall study workflow.
Coordinated data management for over 14 oncology studies, ensuring timely data collection and enhancing research accuracy and integrity.
Maintained meticulous records and adhered to protocol requirements, ensuring compliance with budget constraints and research integrity.
Fostered collaboration with study monitors to streamline data collection, improving overall workflow and enhancing team productivity.
PATIENT COORDINATOR HAND CTR 7/98 –8/06
Analyzed patient data and medical histories to support accurate diagnosis, contributing to improved treatment outcomes and streamlined processes.
Acted as a liaison between patients, physicians, and staff, fostering teamwork and ensuring seamless communication for optimal patient care.
Maintained precise patient records and prepared necessary documentation, supporting clinical operations and enhancing overall efficiency in the clinic.
Implemented a patient follow-up system that improved adherence to treatment plans, resulting in noticeable gains in patient health outcomes.
Coordinated patient care between multiple specialists, enhancing communication and ensuring seamless treatment pathways for improved patient outcomes.
ORTHOPEDIC INSTRUCTOR/WRITER 6/94-7/98
Mentored and guided students, fostering a collaborative learning environment that contributed to several achieving Distinguish or Honor Graduate status.
Analyzed student performance data to tailor instructional methods, resulting in marked improvements in understanding complex subjects like Anatomy and Physiology.
Developed and implemented comprehensive lesson plans, enhancing student engagement and ensuring successful outcomes in technical examinations.
Streamlined course administration processes by integrating updated technology, improving efficiency and resource management within a $150,000 budget.
Coordinated with military services to align course content with operational needs, ensuring students met all requirements for successful training completion.
Analyzed student performance data to tailor instructional methods, resulting in marked improvements in understanding complex subjects like Anatomy and Physiology.
CERTIFICATIONS/ LICSENSE National Board for Orthopedic Technologists, 1995-current
Bone Densitometry, 1999-current
AFFILIATIONS Non Commission Officers Association
National Association Orthopedic Technologist
EDUCATION University Phoenix
Instructor Faculty Development Course (Army)
Military Leadership Course
SKILLS Research Methodology -Ethical Compliance - Regulatory Affairs
Data Integrity- Clinical Auditing- Quality Assurance- Staff Training
GCP Data Management
FDA Regulations HIPAA
Patient Care Project Management
Clinical Trials Budget Development & Management
Team Leadership IRB Process
Medidata Rave. Inform
RedCap. Epic/CareConnect
Microsoft Office
BILINGUAL English, Spanish
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