Dr. Norma Lyn Email & Phone Number

Oviedo, Fl, Us

Remote

Facilitate communication and coordinate information flow between PPD teams, sponsors, and functional departments to ensure effective site activation.Develop recommended plans and guidelines for project implementation using PPD tools, ensuring alignment with project goals and objectives.Monitor and analyze project status to ensure successful progress and completion of all projects, and provide metrics and updates to upper management as necessary.Identify and assess potential risks, and provide contingency planning to minimize potential project impact.Collaborate with PPD teams to manage all financial and contractual aspects of the studies related to site activation, ensuring alignment with project budgets and timelines.Work within the Start-up team to establish appropriate controls and processes to ensure project resources and expenses are aligned with budgets, with accountability to Global Project Management.Administer the technical and operational aspects of the site activation portion of the assigned projects, including coordination of feasibility, site contracts, and country teams in a matrix environment, while effectively managing scope of work against timelines, costs, and quality standards.

Remote

Manage and oversee the handling and storage of investigational product, research specimen samples, and radiology scans, ensuring compliance with established protocols and guidelines.Responsible for identifying and addressing clinical trial safety and efficacy issues, collaborating with key stakeholders to implement appropriate corrective actions.Conduct site co-monitoring and independent monitoring visits, including Pre-study, Initiation, Interim monitoring, and Close-out visits, while ensuring that all site issues are addressed to resolution.Develop and maintain thorough documentation of study protocol, updating as necessary to ensure compliance with regulatory and ethical standards.Serve as a key contributor to IRB/EC and regulatory submissions, providing expertise and guidance on protocol and technical aspects of clinical trials.Respond to protocol and technical questions from customers and business partners, ensuring that user needs are met in device design considerations, and that user instruction and training materials are developed as appropriate.Gather and organize clinical trial documentation to meet rigorous standards for site approval, and facilitate quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.Support the development and delivery of department training to maximize the success of clinical research, and to ensure that staff are up-to-date on the latest regulatory and ethical guidelines

Orange City, Florida, United States

Accountable for all program deliverables and client relationshipManaged project milestones, allocates tasks to ensure on time high quality deliveryCompleted feasibility questionnaires for prospective new studies as part of business developmentSet-up and conducted SSVs, SIVs, routine monitor visits, and COVsManaged review and execution of CDAs, Master Service Agreements (MSAs), contracts, scope changes and amendmentsContinually sought to improve SOPs to enhance efficiencies and improve overall efficiency, profitability and good standing of the siteConducted ongoing review of recruitment activity, collected weekly metrics, and implemented new strategies to ensure study contracts are reached and exceededDeveloped, presented, and facilitated recruitment/retention training sessions as needed, including internal trainings, study team trainings, and investigator meeting presentationsResponsible for recruiting subjects for study participation via methods including, but not limited to: database review, contacting prior patients, reaching out to patients identified by outreach or advertising, patients who have completed a previous studyConducted pre-screen conversations utilizing sponsor/trial specific pre-screen questionnaire to evaluate potential eligibility for a clinical trialEntered subjects into CRIO-clinical database ensuring accurate information including medical recordsEnsured study subject enrollment logs, pre-screen, and screening log as neededAttended community events to promote APMR and advertise for studiesPerformed study close-out activities such as IP reconciliationPerformed technical requirements of the study protocol, i.e., lab work (processing), blood pressure, electrocardiograms, urine/serum pregnancy testing, any procedure necessary for the protocol as ordered by the investigator or specified by a protocolExpertise with Clinical Data Management, Electronic Data Capture (EDC), CRF design & SQL

Lake Mary, Florida, United States

-Managed project milestones and allocated tasks to ensure on-time high-quality delivery-Completed feasibility questionnaires for prospective new studies for business development-Conducted SSVs, SIVs, routine monitor visits, and COVs for study set-up and conduct-Continually sought to improve SOPs to enhance efficiencies and improve overall efficiency, profitability, and good standing of the site-Conducted ongoing review of recruitment activity, collecting weekly metrics, and implementing new strategies to ensure study contracts are reached and exceeded-Developed, presented, and facilitated recruitment/retention training sessions as needed including internal trainings, study team trainings, and investigator meeting presentations-Recruited subjects for study participation via methods including but not limited to database review, contacting prior patients, reaching out to patients identified by outreach or advertising, patients who have completed a previous study-Conducted pre-screen conversations utilizing sponsor/trial-specific pre-screen questionnaire to evaluate potential eligibility for a clinical trial-Participated in the development, review, and implementation of SOPs and processes-Ensured continuous supply of IP for clinical trials through effective monitoring and maintenance-Provided clinical trial communications, regulatory compliance, and contract/budget negotiation-Reviewed source documents and created queries for CRCs to address per protocol-Communicated with potential study patients about protocols and enrollment processes-Coordinated approval of new study agreements and contracts-EDC review of all studies, including Imedidata Rave, Medrio, etc.-Reviewed assigned protocol including study timelines, inclusion and exclusion criteria-Assisted with the conduct of routine audits of clinical files to ensure that regulatory documents are collected-Supervised the development of study-specific Data-Assisted in the hiring and training of personnel

Daytona Beach, Florida, United States

Instructed both lecture and lab for Anatomy & Physiology II.Prepared course plans and materials.Maintained student attendance and grade reports.Provided support in curriculum development and textbook selection activities.Recommended improvements to current instructional methodologies.Assisted in resolving academic issues promptly.Adhered to academic policies at all times.

Port Orange, Florida, United States

Oversaw protocol adherence and ensured regulatory compliance for orthopedic and upper cervical specific research (NUCCA) studies, maintaining the highest standards of accuracy, completeness, and timeliness in all aspects of data management.Conducted rigorous examination of research data abstracted from source documentation to ensure accuracy and completeness before entering into the protocol database, maintaining strict adherence to established guidelines and procedures.

Tampa, Florida, United States

Executed laboratory experiments, following established procedures and protocols, and recorded and analyzed data with a high level of accuracy and attention to detail.Demonstrated proficiency in the operation and maintenance of laboratory equipment and instruments, ensuring their proper functioning and troubleshooting issues as needed.Maintained up-to-date knowledge of laboratory techniques, scientific principles, and safety procedures, and applied this knowledge to the development and optimization of laboratory procedures.Assisted with the preparation of laboratory reports and manuscripts for publication in scientific journals, and presented research findings at conferences and meetings.Collaborated with interdisciplinary teams to ensure the smooth and efficient conduct of laboratory experiments, and to ensure compliance with institutional and regulatory guidelines.Obtained IACUC certification and conducted animal experiments in accordance with ethical standards and regulatory requirements.Designed and executed clinical research studies, including the development of study protocols, informed consent documents, and recruitment materials.Conducted and managed CRO-sponsored studies, ensuring the timely and accurate collection and analysis of data, and the generation and maintenance of study support materials.

Tampa, Florida, United States

Plan, execute, and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities, demonstrating strong leadership skills and ability to work independently.Define requirements for regulatory submissions, and review all content for conformance with established requirements, ensuring that all regulatory filings are accurate, complete, and timely.Serve as a project team leader, responsible for ensuring and enhancing regulatory compliance with respect to filing requirements for assigned compounds, and providing guidance and expertise to cross-functional teams.Evaluate change proposals for regulatory impact and filing requirements, ensuring that all changes are implemented in accordance with regulatory requirements.Lead, coordinate, author, critically review, and provide strategic input on regulatory filing documents, including INDs, NDAs, BLAs, and other regulatory submissions, ensuring that all documents are of high quality and comply with regulatory guidelines and requirements.Provide regulatory assistance and review of clinical study documentation, including clinical protocols, informed consent documents, and clinical study recruitment materials, to ensure that all documents are in compliance with regulatory guidelines and requirements.

Doctor'S Degree, Chiropractic

Master'S Degree, Clinical/Medical Laboratory Science/Research And Allied Professions, Women'S Health Concentration

Pre-Clinical Health Sciences, Health Services/Allied Health/Health Sciences, General, Minor: Health Service Administration, 3.7