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Data Management Clinical

Location:
Silver Spring, MD
Salary:
150000
Posted:
March 27, 2024

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Resume:

Junior Max Destine

Fenwick Apartments

**** *** *** #***

Silver Spring, MD 20877

ad4mc0@r.postjobfree.com

ad4mc0@r.postjobfree.com

202-***-****

Fifteen years plus of relevant population health and clinical experience working with infectious diseases such as HIV, Chikungunya, dengue fever, and Malaria in Havana Cuba while conducting data review. During the door-to-door initiative for dengue fever, and responsible for the oversight of clinical data management deliverables. collecting real-world evidence data for patients who presented with low CD4 and high viral load in a research project sponsored by the department of public health. I have performed project management for all infectious diseases for data management activities. At Woodburn Medical Park, I gain skills such as regulatory requirements and guidance for data management and electronic information systems for clinical trials in covid 19 patients, where I earned practice in CDISC requirements, ICH Good Clinical Practice (GCP), and Good Clinical Data Management Practices

(GCDMP) into routine oversight functions. I also learn how to maintain high-level oversight on data quality metrics and data management deliverables at the Hyperbaric medical group and Claude Mandel Medical Clinic. I also reviewed the development of database specifications, as a bilingual interview for Westat in a study sponsored by CDC and FDA. I had tremendous experience implementing clinical protocol and data management at IQVIA and Westat. I ensure safety data standards and data management plans; validation plans that come with case report forms at Claude Mandel Medical clinic, IQVIA

(Woodburn Medical Park), Westat, RSA Medical, and Hyperbaric Medical Group. Citizenship: US

Relocation: Yes

PROFESSIONAL EXPERIENCE

PROSPECT COLLEGE

Medical Instructor - Washington, D.C. 5/20/22- 01/20/ 23 Prospect College is a vocational school located in the heart of downtown Washington, D.C. not far from the Farragut North and Farragut West metro stations.

● Teach medical terminology and Electronic Health Records to students who are currently studying to work in a medical office and become medical assistants.

● Extensive experience with Strong Clinical Skills (EKG, Phlebotomy, Triage, Injections, Vitals, etc.)

● Experience teaching courses in Electronic Health Records (EHR & EMR)

● Working knowledge of Microsoft Office Suite: Word, Excel, PowerPoint

● Strong ability to manage the classroom and students.

● Academic Leadership experience demonstrated to students.

● More than fifteen years of working with Microsoft Word, Excel, Moodle, and different systems. Reason for leaving: contract end

“The Center for Cancer and Blood Disorders”

Clinical Research Coordinator for NHL/ ITP 12/06/2021-4/18/2022 Bethesda, Maryland

● Extensive experience in data entry into the EDC system and OncoEMR.

● Experience with Chart Review in previous years of employment.

● Obtain knowledge while working on Pre-screening, while knowing the study well to discuss inclusion & exclusion criteria.

● Able to remove Query resolution to allow a smooth transition in data entry into the EDC system.

● Tremendous Experience working with EDC and EMR systems. Ability to juggle multiple-sensitive, high-priority studies.

● Write IRB reports and present them online to the group.

● Provides technical and administrative direction for personnel performing software development tasks, including the review of work products for correctness, adherence to the design concept and to user standards, and progress in accordance with schedules.

● Must be able to coordinate with the Program Manager to ensure problem solution and user satisfaction.

Reason for leaving: 5 months contract end

Griffin Population Analytic, PLC, New Brunswick, NJ Chief Population Health Management Of icer 11/2020 – 10/2021

● Serves as a principal thought leader for population health program development and research, health economics and outcomes research (HEOR), providing strategic vision and direction to departments to ensure innovative models of health care delivery, and full execution of population health strategies that lead to high quality, patient-centric health and service outcomes of patients enrolled managed lives, including complex case management, disease management programs, health risk assessment, wellness, and lifestyle management strategies, health education programs, outreach and other programs for specific populations.

● Develops tools to monitor outcomes, specifically population health indicators such as patient activation, quality of life, disease-specific clinical outcomes, and health risks; lines of business-specific utilization, financial trends, and return on investment/cost/benefit analyses; population health analyses such as overall morbidity and disease patterns, overall social and environmental factors, and overall work productivity.

● Effective learning experiences which create a high-performing healthcare workforce. Real-world, dynamic learning solutions, exclusively for GPA.

● Recruit population health physicians, physician assistants, Nurses, Certified Nursing Assistant, and Nurse Practitioners for the population health (Griffin Population Health) for all sites. ● Experience with Learning Management Systems (LMS), and cross-functional collaboration. ● Oversees and finalizes the negotiation of managed care contracts with new and existing providers based on prior contract performance, future potential, and thresholds approved by the Board. ● Responsible for contractual and budgetary management of observational and epidemiological research studies.

● In partnership with the Chief Quality Officer (CQO), develops MDF Clinical Quality Improvement strategies, including the development and evaluation of the quality standards and audit plan for MDFs.

● Monitors the provision of safe quality care to eligible beneficiaries through key performance indicators developed with the CQO to capture the performances of the contracted facilities using the broad categories of clinical excellence, patient and staff experience, population health status, and prevalence studies/data, which shall be benchmarked against local and internationally recognized medical centers to ensure continuous improvement of the quality of contracted facilities.

● Directs the establishment and maintenance of internal communication and education processes that assure operations are conducted in compliance with contractual terms, and the establishment and maintenance of ongoing tracking and reporting systems and methodologies, to measure and document departmental and contract performance.

● Coordinates with all relevant departments to ensure that the managed care functions are conducted in an accurate and timely manner in compliance with all regulatory and contractual requirements.

● Maintains relationships with related or affiliated physician organizations regarding managed care activities, including, but not limited to, negotiation and implementation of risk-sharing agreements, out-of-network contracting, communication, and operational coordination.

● Collaborates with the relevant communication Department to plan and implement communications regarding contract negotiations to the following audiences: internal medical staff, medical groups, and patients, as applicable.

● Works with industry standards for clinical data management that consist of best business practices and acceptable regulatory standards such as GCDMP.

● Manage various cross-functional data management-related processes, and work with validation plans.

● Process Data Review for our clinical practice in NJ, and online data review for online practices as well.

● Proficiency in CFR21 Part11, GAMP5, ICH E6 R2, ISO.

● Experience and extensive knowledge in cross-functional data management-related processes and data management requirements.

● Prepares milestone status reports and deliveries/presentations on the system concept to colleagues, subordinates, and end-user representatives

● Provides daily supervision and direction to support staff.

● More than fifteen years of computer experience working independently or under general direction on complex application problems involving all phases of systems analysis.

● Supervise team that finishes to write an operational manual on a low threshold buprenorphine document for Camden AHEC and Griffin Population Analytics. Reason for leaving: I serve as a consultant on the board of the company, but I no longer work on day-to-day operations due to the contract we had. It ended in October 2021. Woodburn Medical Park, Annandale, VA(CONTRACT)

Clinical Study Coordinator and Research analyst 09/2020 – 7/30/2021 IQVIA Clinical studies sponsored by Eli Lilly focused on COVID 19 clinical trial.

● Input epidemiological study data into trial Electronic Data Capture (EDC) Veevault, maintaining quality control for content, accuracy, and completeness.

● Compliance background in quality with IQVIA by protecting the interest of the company. ● Case investigation experience on Covid-19 treatment with monoclonal antibodies. ● Verify and/or correct research study medical information on source documents including research queries and variances, while providing feedback to the site data collector.

● Prepare and maintain research study files by compiling, collating, and submitting study information within established deadlines.

● Assist in the maintenance of regulatory documentation, budget management, and contract overview.

● Schedule subject visits and generate appropriate reports and documents for research subjects prior to visits.

● Input visit data into the clinical trial management system (CTMS) to track patient visits and procedures completed against the study budget.

● Master and expert in creating validation plans and extensive knowledge of GCDMP. ● Processing of required lab specimens, labeling of vials, and accurately filling out requisitions for storage and/or shipment per the study protocol and packaging and shipment regulations; Performing various administrative support functions such as reception, office organization, and office supply management.

● Gain skills such as regulatory requirements and guidance for data management and electronic information systems for clinical trials in covid 19 patients, practice in CDISC requirements, ICH Good Clinical Practice (GCP), and Good Clinical Data Management Practices (GCDMP) into routine oversight functions.

● Ensure safety data standards and data management plans, and validation plans. Reason for leaving: My contract ended with IQVIA during that time, and I was hired by Joule. Accotink Academy, Springfield, VA (COVID-19 EXIT)

Professor of Health, Biology, Physics, Chemistry 01/2020 – 03/2020

● Create daily lesson plans and learning activities for students based on national, local, and school standards in science education and research and knowledge of developmental behaviors. ● Explore the LMS that powers 5- 12 grade education in the classroom or from a distance. Improve data flow, boost classroom communication, and create a superior family experience. ● Deliver high-quality, engaging instruction in the form of discussion, direct teaching, demonstrations, and independent practice using a variety of proven methods.

● Differentiate lessons when needed to give all students access to the curriculum regardless of disability, instructional level, English proficiency, or level of interest in the subject. ● Evaluate student performance on tasks established by the standards using different methods such as observation, performance-based tasks, or other standard test practices.

● Maintain a safe, orderly, and supportive classroom by modeling expected behavior and standards, promoting positive interactions, and quickly addressing behaviors that are not in line with the school discipline plan.

● Communicate with parents regarding student progress, potential, and behavior periodically through phone or electronic means and at parent and teacher conferences.

● Improve skills and knowledge in teaching by regularly taking classes, attending workshops, and discovering new methods of delivering exciting content to students.

● Teach biology, health, chemistry, and physics to high school grade-level students. Reason for leaving: Because Covid-19 started at that time, and our school did not go online. The school terminated the contract right away, we could not see any students. Ana G. Mendez University, Silver Spring, MD (PART-TIME CONTRACT) Adjunct Professor 12/2019 – 3/01/2021

● Professor of Microbiology, and basic sciences, microbiology professor of nutrition and prevention, fundamental of health services and evaluation, health science research, attitude development & university adaptation.

● Facilitates courses as assigned per semester in his area of academic and experiential preparation.

● Facilitates the exposure of students to learning experiences in compliance with the modules approved by their department or academic unit.

● Informs students of all language and technology resources available to support the learning process of becoming proficient in English and in Spanish.

● Keep students informed as to how they are professing in the course by providing verbal and written periodic reports.

● Makes effective decisions to solve situations in the classroom that ensure compliance of the policies and procedures established by the university.

● Maintains and disseminates current information pertaining to services available to students throughout the institution.

● Participate in all of the professional development workshops required by the institution in order to improve skills, knowledge in content and languages, and investigative practices for the purpose of enhancing and improving the academic performance of the students.

● Contribute to the development of curricula through the planning, development, and evaluation of courses.

● Recommend changes in the curriculum, in the development of new programs, enhancement of the Discipline-Based Dual Language Immersion Model, and in valuation techniques to be incorporated in each of the campus’s course offerings based on current research with the area of discipline expertise.

● Participate in institutional and academic meetings, committees, and other university-sponsored activities.

● Stay current on facilitation techniques, dual language, adult education, curriculum design, instructional technology, and constructivist activities to enhance instructional modules and products.

● Participate in the Discipline based dual language immersion model and the characteristics of the dual language professional.

● Participate in learning styles and facilitation approach for the dual language higher education learner.

● Participate in second language acquisition and learning. Reason for leaving: My contract for Lecturing part-time at night ended in March 2021. North Broward Technical Center, Deerfield Beach, FL (PART-TIME CONTACT) Adjunct Professor of Basic Sciences 01/2019 – 08/2019

● Teach prerequisites for Nursing students, and teach Pharmacology, Medical-Surgical I&II, Psychiatry, and drug dosage calculations.

● Creates, distributes, and reviews the course syllabus.

● Utilizes a variety of instructional strategies to engage students, including cooperative and experiential learning.

● Presents prepared materials and supervises organized activities.

● Maintains records of student attendance, involvement, and progress.

● Teaches assigned class material in accordance with learning objectives that are developed by the department.

● Communicates with students outside of class to provide supplementary instruction, when necessary.

● Participates in faculty meetings involving departmental updates.

● Initiate, facilitate, and moderate classroom discussions.

● Prepare and deliver lectures to students on topics such as pharmacology, mental health nursing, and community health care practices.

● Keep abreast of developments in their field by reading current literature, talking with colleagues, and participating in professional conferences.

● Prepare course materials such as syllabi, homework assignments, and handouts.

● Supervise students' laboratory and clinical work.

● Evaluate and grade student’s class work, laboratory and clinic work, assignments, and papers.

● Collaborate with colleagues to address teaching and research issues.

● Reason for leaving: It was a private institution, and the owner was a friend who allows me to contract for 7 months, he knew my abilities to teach, and I left because my parents were sick in Maryland, even though I could have renewed the contract, but I had to be there due to the episodic hypoglycemia of my father. AFC Urgent Care Bronx Webster Ave (Dr. Ishmael M. Griffin), Bronx, NY Observership (UNPAID) 12/2017 – 10/2018

● Formal shadowing experience.

● Enable the Observer to watch the procedure.

● Discuss medicine topics daily with a mentor.

● Learn on a state-of-the-art Electronic Medical Record

● Improve physical examination skills.

● Improve patient note-taking skills.

● Improve history-taking skills.

● Observe how to perform EKG, Phlebotomy, PFTs, and UA.

● Discuss medicine topics and the latest guidelines daily with a mentor. Reason for leaving: The volunteer position at Urgent Care was totally dependent on each time I wanted to volunteer. I had no contracts with them. I could leave at any time. Hyperbaric Medical Group Inc., Christiansted, USVI

(CONTRACT) Healthcare Consultant 03/2017– 09/2017

● Perform complete analysis within the scope of the medical issues from simple to complex.Supervising assistant physicians and nursing practitioners.

● Ensure integration of medical services into PHC's overall comprehensive services.

● Perform clinical supervision of medical staff, including regular performance appraisals and feedback to staff.

● Provide supervision of clinical scheduling.

● Provide supervision of continuing professional education, in-service training, and orientation of new medical staff. Approval of student affiliation agreements and student rotations, responsible for the overall performance of clinical students in the health center.

● Provide counsel in personnel matters relating to the clinical staff.

● Facilitate medical staff/provider meetings.

● Perform or delegate responsibility for quarterly medical record reviews for all medical staff focusing on the quality of care and appropriate coding.

● Performing timely admissions including a review of medical records.

● Staff with treatment modalities pertinent to PHC patient populations. Reviews input from medical staff on their ideas and concerns with the executive director.

● Maintain high-level oversight on data quality metrics and data management deliverables.

● Provide a reference to clinical data managers in their implementation of high-quality Clinical Data Management processes and is used as a guidance tool for clinical data managers when preparing for CDM training and education.

● Master and expert in creating validation plans and extensive knowledge of GCDMP. Reason for leaving: It was a consultant contract between Dr. Ian Cook and me to set up EMR (Practice Fusion) and perform the following duties above. The contract ended and I left. Claude Mandel Medical Center (Dr. Claudia Johnson), Chicago, IL Clinical Research Externship (UNPAID) 01/2015 – 05/2015

● Clinical trials management / Data collection management.

● Collection of personal data and informed consent.

● Management Modules for Osteoporosis.

● Presentation of Clinical trial data.

● Management and supervision of data collection.

● Maintain high-level oversight on data quality metrics and data management deliverables Reason for leaving: It was a school externship, and it was unpaid, I left because the timing of the externship was only 4 months.

WESTAT, Rockville, MD (CONTRACT)

Certified Bilingual Interviewer 05/2014 – 12/2014

Population assessment study for tobacco and health for the CDC and FDA

● Accurately review observational and health data obtained from the interview.

● Case investigation experience in chronic lung diseases and lung cancer.

● Ask questions about lung cancer for patients and survey about different symptoms to detect lung diseases.

● Contact study participants by phone and data Collection for study.

● Clinical trials coordination and participating in different phases of clinical trials.

● Analyze data submitted by interviewees.

● Handle and protect confidential and sensitive data with integrity.

● Participate in training and team meetings.

● Contact research subjects to recruit participants and schedule meetings.

● Coordinate with teammates to organize efficient travel and two-person interviewing.

● Travel into the cities and neighborhoods of Baltimore to conduct interviews.

● Follow protocols, interviewing research subjects professionally and courteously.

● Clean and enter data from completed questionnaires.

● Respond to special needs of the CSR team related to the field research project.

● Ensure safety data standards and data management plans, and validation plans.

● Master and expert in creating validation plans and extensive knowledge of GCDMP. Reason for leaving: My contract was set for December of 2014; this is the main reason I left. I was a bilingual interviewer for a Population assessment study for tobacco and health. The study was sponsored by the FDA and NIH. I was hired by Westat to perform the duties above. RSA Medical, Naperville, IL (CONTRACT)

Case Manager 09/2013 – 04/2014

● Interview study participants and collect study-related data.

● Manage multiple clinical trials.

● Initiation of clinical trials based on their protocol and study directions.

● Admits new clients by reviewing records and applications, and conducting orientations.

● Determines clients' requirements by completing intake interviews; determining the need for therapeutic medical, psycho-social, and psychiatric evaluations; reviewing therapist evaluations, treatment objectives, and plans.

● Maintains clients' records by reviewing case notes, and logging events and progress. ● Communicates clients' progress by conducting weekly interdisciplinary meetings and evaluations; disseminating results and obstacles to the therapeutic team and family; identifying treatment influences.

● Ensure safety data standards and data management plans, and validation plans. Reason for leaving: My contract ended in April, it was one contract that did not have an extension for more months. Washington Adventist Hospital, Takoma Park, MD

Volunteer (UNPAID) 08/2012 – 08/2013

● Receives and screens telephone callers, provides information per service area/Hospital policy, and/or routes calls to appropriate personnel.

● Greets patients, visitors, and staff to the office/service area, determines their need (s) and assists/directs them accordingly.

● Assists patients with comfort needs and emotional support, as assigned.

● Take instruments to be sterilized in the sterilization room.

● Have access to observe physicians and Physician assistants performing surgeries in OR. Reason for leaving: The volunteer position at the Hospital totally depended on each time I wanted to volunteer. I had no contracts with them. I could leave at any time. INTERNATIONAL FIELD & ENVIRONMENTAL HEALTH

EXPERIENCE Clinical Experience Internship Experience (UNPAID)

● Hospital Dr. Salvador Allende, Havana Cuba (Internal Medicine) 08/2011 – 10/2011

● Polyclinic Heroes of Giron, Havana Cuba (Family Medicine) 10/2011 – 12/2012

● Hospital Pediatric of Cerro, Havana Cuba (Pediatric) 12/2012 – 02/2012

● Hospital Salvador Allende, Havana Cuba (Surgery) 02/2012 – 04/2012

● Hospital Hijas de García, Havana Cuba (OB/GYN) 04/2012 – 06/2012 Clinical Research Experience (UNPAID) 09/2006 – 09/2012 Engaged in Late Phase clinical trials focused on fighting the dengue epidemic in Havana Cuba, collecting epidemiological data from patients, and writing the number of patients who presented with alarming symptoms.

● Participate in Salvador Allende Hospital Havana Cuba in observational research about diabetic gangrene, and collect previous and after treatment data with patients that had been treated with Heberprot-P.

● Collecting real-world evidence data for patients who presented with low CD4 and high viral load as a medical student/research project and a final project.

● Applying epidemiological approaches in global and environmental health research and practice for analyzing the roles, relationships, and resources of the entities influencing global health in Cuba.

● Applying monitoring and evaluation techniques to global and environmental health programs, policies, and outcomes.

● Proposing sustainable ethical and evidence-based multi-sectoral interventions, considering the social determinants of health specific to the local area.

● Designing sustainable workforce development strategies for resource-limited settings.

● Practicing critical self-reflection, cultural humility, and ongoing co-learning in global health. Understand common barriers to the implementation of global and environmental health programs in a developing country and strategies to minimize their impact

. ● Identify strategies for scaling up and sustaining programs in global and environmental health.

● Apply global and environmental health competencies and skills to real-world problem-solving.

● Demonstrate practical skills including collaboration and partnering, ethical reasoning and professionalism, socio-cultural and political awareness, and promotion of health equity and social justice in the context of advancing global and environmental health and international development.

● Define key elements of cultural humility in global and environmental health practice

.● Reflect on one’s cultural identity and values and their influence on one’s values, beliefs, assumptions, and behaviors.

● Assess methods for bridging cultural differences in the context of public health practice. Clinical & Herbal Inc. Alexandria, Virginia

Medical Liaison position 08/2012 – 08/2016

● work with Medical Relations and KOLs regarding investigator-initiated trials

● Serve as an internal medical and scientific resource responsible for developing strategic communications and other materials supporting product information.

● work with the head of Professional Marketing & Relations for the client to share relevant scientific information internally from journal articles to keep the various teams aware of scientific news within the dermatology space.

● Support the use of our client’s products through HCP advocacy development and implementation of peer influence programs.

● Develops and maintains strong scientific knowledge of the current competitive landscape and competitive messaging.

● Upon request, presents clinical data to healthcare professionals (scientific peer to peer) including physicians, academic institutions, researchers, and other health care professionals.

● Provide approved information to customers to ensure access to current medical and scientific information as necessary.

● Upon request, assist or lead regional speaker bureau or online training programs in support of clients.

Reason for leaving: My contract ended

EDUCATION/TRAINING

● B.A in Biology & Minor: Chemistry, Columbia Union College Takoma Park, Maryland (2002-2006)

● M.D. in General Medicine, Escuela Latino Americana de Medicina Cuba, Havana (2006-2012)

● Master of Public Health, Drexel University Dornsife School of Public Health Philadelphia, Pennsylvania (2016-2018)

● Certificate in Global Health, Drexel University Dornsife School of Public Health Philadelphia, Pennsylvania (2018-2019)

● MBA in Pharmaceutical & Healthcare Business, Philadelphia College of Pharmacy, University of The Sciences, Mayes College of Healthcare Business and Policy Philadelphia, Pennsylvania

(2018-2021)

● University of Pittsburgh ( Physician Associate program) (2023-2025) CERTIFICATION

● 2023-2025 ACLS

● 2023-2025 BLS

● 2023-2025 CPR FIRST AID/AED

● 2020- Certificate of completion CWSE5691: Child Abuse and Neglect: Recognizing, Reporting and Responding for Educators offered by Virginia Department of Social Services.

● 2020-Certification of Completion Dyslexia awareness module issued by Virginia Department of Education 2020 Board Certified of Medical Affairs, MLS in process.

● 2020 Covid-19 Study with Eli Lilly J2W-MC-PYAB Certificates: Amendment (j) Delta training, Amendment (i) Delta training, Amendment (f) Delta training, Amendment (e) Delta training, Amendment (c) Delta Training, Protocol Overview, Study Hub Training for Sites, eSAE and SAE Reporting, Direct Data Capture, Compound Overview, Clinical Operations, ICH GCP Investigator Training

● 2020-2023 CITI (Collaborative Institutional Training Initiative) Biomedical Research - Basic/Refresher Certificate under the requirement set by Clinical Consulting Services LLC.

● 2020-2023 CITI (Collaborative Institutional Training Initiative) Good Clinical Practice (U.S. FDA Focus) Certificate under the requirement set by Clinical Consulting Services LLC. DISEASE INVESTIGATOR EXPERIENCE IN CUBA (DENGUE FEVER) 2006-2012 Unpaid Experience

● Use Rapid surveys or other study designs used in outbreak investigations for dengue fever.

● Addressing the operational aspects related to preparing for fieldwork.

● Interviewing the affected persons by dengue fever and contact tracing all people who have been in contact with the affected person.

● Clinical examination of the affected persons by health-care personnel when indicated and possible.

● Reviewing medical records and other pertinent clinical information (e.g., radiography and other imaging studies).

● Confirming the results of laboratory testing for dengue fever.

● Assessing the adequacy, accuracy, or meaning of the



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