CANETTE ALEXIS-LOUIS SUCCE

ad4jta@r.postjobfree.com / 252-***-****

EDUCATION

UNIVERSITY OF FLORIDA; Gainesville, FL December 2020 Master of Science in Microbiology and Cell Science Concentration: Medical Biochemistry and Medical Microbiology EAST CAROLINA UNIVERSITY, Greenville, NC May 2016

Master of Education in Middle Grades in Language

Arts Concentration: Middle/Secondary Grades Science and English

UNIVERSITY OF FLORIDA; Gainesville, FL May 2013

Bachelor of Science in Family, Youth, and Community Sciences Concentration: Certified Family Life Educator

INTERNATIONAL DOULA INSTUTITE; Merion Station, PA December 2023 Breastfeeding counselor

Perinatal nutrition Educator

Postpartum Care

Childbirth educator

IDI Birth care

PUBLICATIONS/MANSCRIPT

• Multicenter Analysis of Mechanisms of Resistance to Osimertinib (O) in EGFR Mutated NSCLC: An ATOMIC Registry Study (2020)

• Overcoming Antibiotic Resistance in 21st Century (2019) RESEARCH EXPERIENCE

Elligo Health Research; Raleigh, NC May 2022-Current Senior Study Manger/ Senior Clinical Research Coordinator

• Developed strong working relationships and maintained communication with All study team members and stakeholders within the psychiatric office at Mindpath Clinic in Raleigh, NC

• Supervised and trained other study coordinator/managers and CRAs across different eTMF systems and EDC intELLIGO, CASTOR, IBM, Firecrest, PRIA, CRIO-RIMS, VEEVA, Florence within the company and outside the organization.

• Current liaison for study coordinator/managers, clinics and sponsors for study and clinic related activities such LIVANOVA, AKILI, BIOGEN, LUMOS, ICON, PROTRIALS, APERIO for study acquisition and start-up

• Provided supervision of study coordinators/managers on multiple concurrent trials on ADHD, Bipolar and Depression and Atopic dermatitis studies and alopecia

• Project manager for 6 study startups from regulatory management to coordinating meetings to ensuring all requirements for site activation for ICH, GCP compliancy

• Confirmed principal investigator renewals and licensure, quoted insurance liabilities for clinical sites, requested marketing approvals applications for sites such as Facebook meet ups and ads running on Instagram

• Mentored and trained study team members from other site locations on multiple RIMS systems for regulatory assembly of binders in TMFs- FLORENCE

• Assisted in the informed consent process of research subjects for all active studies via docusign and FirstDoc

• Supported the safety of research subjects, reported adverse events and coordinated contact with investigators and IRB and submitted continuing reviews, created TMF content of tables and protocol deviations to Advarra, WCG and Firestcrest and SAEs systems

• Administers biologics, vaccines and injections for study subjects

• Coordinated protocol related research procedures, study visits, and follow- up for six studies

• Completed all study activities such pre/screening, recruiting and enrollment of research subjects over 80 subjects

• Facilitated pre- study, site qualification, study initiation, monitoring visits, site feasibilities and study close out activities for ADHD, bi-polar and depression studies and medical device installations and training

• Completed close-out visits for eight studies and took care six studies and reconciled over 300 queries, PDs and NTFs and discovered a CAPA for an assessment that was completed without patient consent form on file.

• Created and reviewed paper Case Report Forms (CRFs) for studies associated with two clinical sites UNIFIED WOMEN’S HEALTHCARE; Raleigh, NC November 2021-May 2022 Clinical Women’s Research

Clinical Site Manager/ Study Start Up Associate

• Reason for leaving: This position was during my internship while getting several certifications for Midwifery and Doula certification. I was offered a permanent position with Elligo and benefits.

• Managed 12 PI initiated and Sponsored initiated Studies about endometriosis, conception, and urine incontinence Recruited subjects into studies and completed patient study visits

• Managed regulatory through TMF system CLARIO

• Processed UPT, dipstick, urinalysis, and other vaginal specimen for Abbie, Pfizer studies

• Responsible for site maintenance and IRB compliance as regulatory assistant

• Project manager for 6 clinical research coordinators and collaborated with PIs in study completion and follow up and close outs visits Completed drug accountability tasks

• Shipping out regulatory binders back to CRO and sponsors and for new sites or transferred sites

• Data management specialty and auditing regulatory, created visual presentations for regulatory via SPOTFIRE and Qlik Sense

• Collected regulatory documentation from all relevant study staff

• Collaborated with monitors for SMVs and IMVs also regulatory maintenance and study start up invoicing

• Responsible for source review for EDCs and Study start-up and for site qualification visits

• Process all initial regulatory documents for submission to the Pharmaceutical Sponsors and Institutional Review Board (IRB)

• Prepared and processed all regulatory documentation through the IRB, CTSRMC, FDA for Abbvie pre-start up study and study delivery timelines SOPs

• Prepared and processed all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA for upcoming post-CTA

• Assist in the development and review of protocols, study budgets, investigator brochures, clinical study reports and other clinical documents and regulatory filings as needed in accordance of ICG and GCP compliancy

• Created and reviewed paper Case Report Forms (CRFs) all studies associated with two clinical sites to better correspond with source

WAKE RESEARCH ASSOICATES; Raleigh, NC October 2021-May 2022 Women’s Studies

Lead Clinical Research Coordinator/ Clinical research monitor

• Reason for leaving: This was a contract job for a temporary hold for an employee that was on FMLE.

• Managed 3 research assistants in lactation studies for Syneos, ORALMED, Protrials, Covance, BIOGEN

• Maintained regulatory documents and complete study follow-ups and study visits via CRIO

• Managed regulatory binders and annual reviews, reporting INDs

• Completed CTA reviews

• In-house CRA monitoring experience

• Startup industry sponsored study for oral insulin: ORAMED study

• Used GENERIS and Encounters in RIMS; managed regulatory system CRIO

• Directly oversaw contract CRAs from ORALMED, BIOGEN studies

• Developed study training materials, case report forms and study tools for assigned women’s studies

• Conduct training for logistics of the clinical trial including protocol contents and coordinating trial materials

• Oversaw monitoring activities and conduct clinical site initiation visits, co-monitoring and close-out visits, as needed

• Manage study timeline and provide study progress reports to management

• Plan ahead and provide solution options for handling problems that develop

• Oversee to ensure that paper and electronic filing systems are maintained appropriately and in a timely manner

• Maintain tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and data cleaning information, etc.)

• Maintained code of ethics and quality control of tasks assigned according to GCPc and SOPs

• Created and reviewed paper Case Report Forms (CRFs) all studies associated with two clinical sites

• Assist in the development and review of protocols, study budgets, investigator brochures, clinical study reports and other clinical documents and regulatory filings as needed in accordance of ICG and GCP compliancy UNIVERSITY NORTH CAROLINA; Chapel Hill, NC January 2019-October 2021 Department of Surgery, Abdominal Transplant Research Clinical Research Coordinator/Team Clinical Lead

• Reason for leaving: This is a permanent position and I transitioned out of this position because of the private sector opportunity to grow into a more management position as a study manager.

• Managed 8 Industry-Sponsored drug treatment studies with a total of 20 patients and two Investigator-Initiated studies

• Closed out two drug treatment clinical trials

• Managed own regulatory portfolio and project management for all active enrolling studies

• Lead coordinator on NOVARTIS Liver study and ProKidney studies and starting enrollment in liver pre- transplant patients

• Completed four in-patient VIR/OR injection procedures for study subjects to disperse biologics

• Prepared for federal audit

• Poster-presentation to Department of Surgery for Site Initiation visits for new ProKidney/InRegen Sponsor

• Completed two start-up 004 and 006 drug treatment trials within a three-month span and currently screened 80 patients for kidney and liver drug treatment trials

• Scheduled and completed research clinic follow-up visits and procedures, maintaining subject research source files, and facilitating study monitor visits

• Collected, processed, and sent shipments of study lab samples including biopsies to Covance and reviewing patient labs and confirming clinic significance with Principal investigators and monitored -80 freezer, and fridges

• Preparing, submitting and maintenance of IRB submissions through WCG (WIRB) commercial IRBs, ADVARRA and UNC IRB, trial sponsor, including financial disclosures, delegation of authority logs, training logs, consent forms, HIPAA forms, IRB application and CVs/licenses

• Regularly conducting subject telephone visits and follow-ups

• Preparing regulatory documents such as amendments, handouts, COIs disclosure, initial reviews, amending UNC IRB contingencies, coordinating revisions with Principal Investigator and sponsor and annual reviews and eReg binders

• Data managed of SAEs and AEs including outcome monitoring and reporting in addition abstracting data into CRFs such as TrialMaster and iMedidata

• Created and reviewed paper Case Report Forms (CRFs) all studies associated with two clinical sites UNIVERSITY NORTH CAROLINA; Chapel Hill, NC

UNC Lineberger Cancer Center, Office of Clinical Translational Research Clinical Study Coordinator

• Reason for leaving: I was given an opportunity to grow into another role while at UNC and was promoted across the division.

• Responsible for coordinating and managing 8 studies simultaneously and creating RedCap databases for breast cancer and working with multiple PIs within the UNC REX and UNC Healthcare Systems.

• Managed and developed 200 sample biobanking of tissue samples

• Developed registries for Neck, Lung, and Head Cancer patients’ tissue procurement

• Trained new research coordinators and research assistants for investigator-initiated studies and industry- sponsored.

• Developed and created Academic Thoracic Oncology Medical Investigators Consortium

(ATOMIC consortium) database for the study

• Recruited, enrolled, and consented 98 study participants for multisite study with UNC healthcare system

• Maintained a tracking log of the statuses of collected samples with several studies

• Monitored recruitment targets for multiple studies and reviewed consent forms

• Monitored and logged the request, retrieval, and review of study images, pathology reports and tissue slides, and conducted data abstraction for ATOMIC study via EPIC and Care-Everywhere EMRs.

• Trained new research assistants and study coordinators for onboarding onto Investigator-Initiated studies

• Data managed of SAEs and AEs including outcome monitoring and reporting in addition abstracting data into CRFs such as TrialMaster and iMedidata

• Created and reviewed paper Case Report Forms (CRFs) all studies associated with two clinical sites

• Assist in the development and review of protocols, study budgets, investigator brochures, clinical study reports and other clinical documents and regulatory filings as needed in accordance of ICG and GCP compliancy

• Collected regulatory documentation from all relevant study staff UNIVERSITY NORTH CAROLINA; Chapel Hill, NC

UNC BioSpecimen Processing Facility, Michael Hooker Research Center Clinical Research Specialist/Study Coordinator (Temporary)

• Reason for leaving: I transitioned as this was a temporary role for the site that ended with a grant.

• Performed laboratory processing and analysis tasks on routine basis

• Cataloged inventory and processed shipping and boxing of samples and equipment

• Maintained a Laboratory Information Management System (LIMS) for biospecimen across multiple projects

• Used LIMS to identify and prepare samples for testing by research collaborators

• Completed DNA and RNA extraction from human biospecimens, such as whole blood and saliva

• Performed quantity and quality assessments of the extracted nucleic acids using Nanodrop and Dropsense

• Completed elution of blood spots and preparation of aliquots from stored human biospecimens such as whole blood, urine, saliva

• Implement research standard operating procedures

• Submitted IND reports and SUSARS reports requiring PI signature and review

• Created and reviewed paper Case Report Forms (CRFs) all studies associated with two clinical sites

• Collected regulatory documentation from all relevant study staff UNIVERSITY NORTH CAROLINA; Chapel Hill, NC

UNC Aiello Research Group, Michael Hooker Research Center Clinical Research Specialist/Study Manager Coordinator

• Reason for leaving: I transitioned as this was a temporary role for the site that ended because of funding.

• Performed quantity and quality assessments of the extracted nucleic acids using Nanodrop and Dropsense

• Completed elution of blood spots and preparation of aliquots from stored human biospecimens such as whole blood, urine, saliva

• Used LIMS to prepare samples and catalog them in freezers

• Monitored cross campus freezers for multiple projects

• Created and coordinated inventory data sets for samples from Germany

• Coordinated packing slips and packaged samples to dozens of facilities and labs associated with biospecimen processing

• Created and reviewed paper Case Report Forms (CRFs) for Aiello studies

• Collected regulatory documentation from all relevant study staff EAST CAROLINA UNIVERSITY; Greenville, NC August 2016-December 2018 Oral Maxillary Disease, Dental School of Medicine

Senior Clinical Research Coordinator, Dr. Heather Sorrows Lab

• Reason for leaving: I was accepted into a second graduate program for Microbiology and Cell Science in Florida.

• Abstracted patient demographics, medical and lab results complete CRFs for data collection on EDC platforms

• Oral maxillary diseases running samples of DNA from buccal tissues

• Completed DNA extraction using Gentra Puregene Blood Kits, Oragene saliva collection kits and plasmid isolation and protein restrictions using ELISA assays

• Assisted in managing a Genologic LIMS system to track sequencing data and get appropriate metrics froma run and help import reports to their HiSeq

• Maintained ultra-low temperature freezers, such as -38 Celsius freezers and kept logs and inventory of equipment used within the lab and ran datasets through SPSS (Statistical Package for the Social Sciences) and NVIVO, a software program used for qualitative and mixed-methods research

• Documented project progress, follow up with actions owners via EXCEL Trackers, and monitor risk mitigation health and status.

• Was responsible for meeting manager and scheduling coordinator meetings, creating staff agenda creation, wrote and distributed meeting minutes

• Created and reviewed paper Case Report Forms (CRFs) via OnCORE EAST CAROLINA UNIVERSITY; Greenville, NC July 2013-May 2016 Culturally Responsive Teaching, College of Education Surveyor/Graduate Clinical Research Specialist, Dr. Christy Rhodes Lab

• Reason for leaving: I transitioned as my internship was finished.

• Processed data sets for English as a Second Language instructors

• Ran 10 datasets through SPSS for statistical analysis on comparative demographics and population evaluation of self-efficacy and NIVO

• Maintained detailed dashboards via PIVOT and risk/action trackers using SPSS and REDCAP

• Documented project progress, follow up with actions owners via EXCEL Trackers, and monitor risk mitigation health and status.

• Was responsible for meeting manager and scheduling Dr. Rhodes coordinator meetings, creating staff agenda creation, wrote and distributed meeting minutes

• Created and reviewed paper Case Report Forms (CRFs) CRT subjects EAST CAROLINA UNIVERSITY; Greenville, NC July 2013-May 2016 FINANCE 101: HOW TO BUDGET, College of Interdisciplinary Professions Graduate Research Specialist, Dr. Scott Williams LAB

• Reason for leaving: I was accepted into a second graduate program for Microbiology and Cell Science in Florida.

• Created quizzes and jeopardy html pages for course textbook

• Cataloged journal articles

• Created and reviewed paper Case Report Forms (CRFs) for culturally responsive subject participants

• Created grading report system

• Evaluated course material for future examinations

• Collaborated on dissertation on CRT, culturally responsive teaching mechanisms

• Trained coordinators on medical device installations

• Ran 10 datasets through SPSS and NIVO, created a short guides review of ISO IDMP standards and xEVMPD UNIVERSITY OF FLORIDA; Gainesville, FL May 2011-May 2013 DEPARTMENT OF CLINICAL AND HEALTH PSYCHOLOGY

Clinical Research Specialist, Dr. Catherine Price LAB

• Reason for leaving: I was accepted into Teach for America and moved to Mississippi and then North Carolina.

• Processed and cataloged intracranial samples for Reaction Time Task in Parkinson’s disease

• Collaborated on abstracts for LVADs

• Received and did processing of CNS tissues samples and cataloged for tissue analysis for PI and CLEAR-LVAD study

• Wrote literature review on compliance and psychological effects of Left Ventricular Assist Device

• Facilitated program developments for IT-SNAP, a skull and muscular tissue program

• Edited poster presentations on left ventricular assist device for stage 4 of heart disease patients

• Follow up on study maintenance on regulatory start up docs

• Assisted lead study coordinator on Barostim Heart Failure Device

• Created and reviewed paper Case Report Forms (CRFs) for LVAD patients within CLEAR study UNIVERSITY OF FLORIDA; Gainesville, FL August 2011-December 2012 DEPARTMENT OF FAMILY, YOUTH AND COMMUNITY SCIENCES INSTITUTE OF FOOD AND ARGICULTURAL SCIENCES LAB

Clinical Research Assistant

• Reason for leaving: I was accepted into Teach for America and moved to Mississippi and then North Carolina.

• Counseled women and men in martial relationships through “Healthy Marriages” Course as IFAS program

• Drafted consent forms for the study

• Managed four study participant tracking databases for implementation & maintenance of Regulatory Information Management Systems

• Wrote literature review on for Family Life practices

• Recruited and consent study participants for multisite study

• Maintained a tracking log of the statuses of collected samples with several studies

• Monitored recruitment targets for multiple studies and reviewed consent forms

• Created 2000 slides CD program for balancing work, family and marriage life

• Created distributions lists for IFAS Extension programs

• Generated Qualtrics surveys for South Florida programs for married couples

• Compiled data sets for immigrant families from Southern part of Florida WORK EXPERIENCE

EAST CAROLINA UNIVERSITY; Greenville, NC June 2018-April 2019 BRODY SCHOOL OF MEDICINE: DEPARTMENT OF PEDIATRICS PEDIATRIC UNIFIED RESEARCH ENTERPRISE

Clinical Study Manager/Clinical Administrative Associate Support

• Reason for leaving: I was accepted into a second graduate program for Microbiology and Cell Science in Florida.

• Reviewed IRB contracts, did track changes amendments, and protocols

• Created SOPS for invoicing industry-sponsored started studies and clinical trials

• Created invoices for all stakeholders

• Processed all research-related travel for PURE (Pediatric Unified Research Enterprise) staff and patients

• Coordinated all research expenses with PURE (Pediatric Unified Research Enterprise) Leadership

• Managed study timelines and provided study progress reports to P.U.R.E management

• Collaborated with team for advanced solutions options for keeping within timelines for deliveries of SOPs, study metrics and meeting enrollment

• Oversaw study coordinators and research assistants to ensure that paper and electronic filing systems are maintained appropriately and timely

• Maintained tracking for study metrics essential to managing the study closely via OnCore for patient visit information, data entry, monitoring and data cleaning information EAST CAROLINA UNIVERSITY; Greenville, NC June 2018-August 2018 DENTAL SCHOOL OF MEDICINE, OFFICE OF THE DEAN

Clinical Administrative Associate Support

• Reason for leaving: I was a graduate student in Education and was doing across the university different work study positions that changed throughout my 3-year education at East Carolina University.

• Developed trackers for Faculty evaluations

• Created evaluation forms for Continuing Medical Education sessions

• Processed all CME credits for Dental faculty

• Created an all-faculty dataset for Continuing Medical Education

• Scheduled and coordinated Dean activities within Staff cohort EAST CAROLINA UNIVERSITY; Greenville, NC July 2017-April 2018 BRODY SCHOOL OF MEDICINE, OFFICE OF MEDICAL EDUCATION Clinical Administrative Support

• Reason for leaving: I was accepted into Teach for America and moved to Mississippi and then North Carolina back again during my training.

• Prepared curriculum presentations for M2 classes

• Collected data sets for M1/M2 classes for quizzes, course evaluations

• Coordinated feedback luncheons

• Provided extensive technical support via blackboard for basic science coordinators

• Facilitated group discussions within OME office and coordinated special event across Student Affairs EAST CAROLINA UNIVERSITY; Greenville, NC December 2016-June 2017 JOYNER LIBRARY, RESEARCH, AND INSTRUCTIONAL SERVICES University Library Technician

• Reason for leaving: I was accepted into Teach for America and moved to Mississippi and then North Carolina back again during my training.

• Processed data sets for Research instruction sessions

• Created lesson plan formats and provided instructional training to faculty librarians

• Created instructional matrices for department

• Taught several library service sessions

• Coordinated outreach events for Joyner Library

EAST CAROLINA UNIVERSITY; Greenville, NC August 2016-December 2016 OFFICE OF UNDERGRADUATE ADMISSIONS

Business Service Coordinator

• Reason for leaving: I was a temporary replacement for employee on short leave.

• Processed reimbursements for admission counselors

• Coordinated Recruiting counselors Travel

• Trained counselors on using BANNER and PORT

• Facilitated travel orders/requests

EAST CAROLINA UNIVERSITY; Greenville, NC July 2015-May 2016 COLLEGE OF NURSING, OFFICE OF RESEARCH AND CREATIVE ACTIVITIES Graduate Clinical Research Assistant

• Reason for leaving: I transitioned because grant funding ended for my position.

• Wrote literature reviews for various faculty and staff

• Edited poster presentations for faculty and staff

• Editorial review of grant proposals and assisted with online submission of grants

• Conducted data entry such as SPSS, data analysis, and provided statistical consultation

• Created data sets for Travel study for African American population with children cohort that collaborated with Dept Peds study groups

• Help submit NIH grants and create bibliographies for proposals

• Transcribed faculty interviews into share sources for committees

• Managed two other graduate assistants

• Monitored vaccines in -30 fridge

• Reviewed paper Case Report Forms (CRFs) all studies associated with two clinical sites EAST CAROLINA UNIVERSITY; Greenville, NC July 2015-May 2016 COLLEGE OF NURSING, LEARNING RESOURCE CENTER

Graduate Assistant-Lab Monitor

• Reason for leaving: I transitioned because grant funding ended for my position.

• Monitored two sections of labs for graduate students

• Coordinated scheduling of students and teachers for the purpose of maintaining computer lab operations and activities.

• Instructs students and teachers in computer lab technology and software applications for the purpose of enhancing their understanding of lab operations and reinforcing academic concepts

• Administer NLN testing for College of Nursing

TEACHING EXPERIENCE

BERTIE EARLY COLLEGE HIGH SCHOOL, Windsor, NC.

Science Teacher/Corps Member

June 2013-June 2015

• Reason for leaving: I was accepted into graduate school in another city.

• Taught honors Earth and Environmental Science, honors Chemistry, and honors Physical Science

• Co-directed a Yearbook Club and served as Advisor for the Yearbook Sub-Committees

• Developed curriculum guides for all teachers instructing honors Chemistry, and honors Physical Science

• Developed instructional templates for exams, quizzes and daily agendas for beginning teacher’s cohort

• Coordinated professional development for beginning teachers in Year 1 and Year 2

• Developed Honors chemistry and Honors physical science curriculum as a board member on teacher advisory for Bertie County

FRIENDS OF THE MICANOPY LIBRARY, Micanopy, FL

Tutor

August 2012-May 2013

• Reason for leaving: I transitioned because grant funding ended for my position.

• Developed lessons plans for African American students that were at-risk youth in rural Ocala region

• Tutored in math, science, biology, physics, and handwriting

• Developed curriculum and instructional guides for undergraduate student tutors

• Created weekly objectives for newly hired tutors

• Coordinated tutor meeting reviews for monthly quarterly teacher/tutor evaluations BEACON CENTER, Lantana, FL

Camp Counselor

• Developed daily lessons plans for Camp Counselors

• Tutored in basic math and language arts

• Developed curriculum map for language arts and math

• Taught Conflict Resolution course to new teaching assistants

• Coordinated end of the summer field trips

April 2006-September 2009

LANGUAGE SKILLS

• Fluent in English, Haitian-Creole

• Intermediate in Spanish and French

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