What I bring• Over 15 years in clinical research starting as a phlebotomist to my most recent role as Region Manager• Extensive Phase 1 Bioequivalence/Bioavailability trials for new generics in both oral and dermatological medications (over 100 trials)• Adhesion and irritation/sensitization dermatology trials• Phase 2/3 in Gastroenterology, Women’s Health, Alzheimer’s, COVID and more recent Cardiology and pulmonology • Management of Clinical Teams • Oversight/monitoring of decentralized trials • Working closely with CRAs • SOP writing and review• Training/work instruction creation• Source and Case Report Form creation• Screening participants• Data Collection, entry and review• Sample collection, processing and shipping• eSource experience – CRIO and One Study Team• eRegulatory experience – Complion and Florence• EDC – Medidata, Inform, Veeva• ISF/TMF Maintenance• IRB submissions • Training• Staff reviews/performance evaluations• Interviewing• Staff allocation/scheduling• Strong desire to expand experience and knowledge everyday by taking on new challenges • And much more
Care Access
View- Website:
- careaccessresearch.com
- Employees:
- 799
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Senior Study Start Up ManagerCare AccessYuma, Az, Us
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Region ManagerCare Access Nov 2023 - Present
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Associate Director, Study ManagementCare Access Jun 2022 - Apr 2023United StatesI prove myself by directing the study management division to provide proper decentralized principal investigator supervision over clinical trials. I worked across many procedures and ensured that the department met the sponsor's objectives, while adhering to the highest industry standards. My Signature highlights of this role include:• Strategized internal goals, processes, and procedures within a fast-growing company, while working with Senior Level Executives and Management across all departments.• Grew department to more than double previous size.
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Decentralized Team Manager Of Study ManagementCare Access Dec 2021 - May 2022United StatesDuring this role, I ensured the study management team met expectations and goals by providing support, guidance, and feedback on performance. Moreover, I communicated with high management on corporate goals and strategy.My major initiatives to produce a favorable result include:• Drove oversight of Study Managers - approximately 30 staff members.
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Certified Clinical Research CoordinatorUnified Women'S Healthcare Jul 2019 - Nov 2021United StatesDuring this experience, I performed a number of duties, including recruiting, screening, data collection, lab collection and shipping, and data input, in accordance with the protocol's criteria. Moreover, I ensured appropriate study materials were available and facilitated site visits with Clinical Research Associates.Some highlights of my efforts to bring a positive outcome include:• Played vital role as primary or backup research coordinator on Phase II and III clinical trials concentrating on health of women, including HPV, recurrent yeast infections, Endometriosis, Bacterial Vaginosis, and Pre-eclampsia. -
Certified Clinical Research CoordinatorFargo Gastroenterology And Hepatology Pc, Inc Dec 2017 - Jun 2019Fargo, North Dakota AreaAssisted a private practice with starting up a research division of the clinic. Reviewed company SOPs. Cataloging and maintenance of necessary equipment. Facilitate and lead site visits. Document creation. Screening study subjects, collection and shipping of laboratory specimens, collection of study data as well as data entry, and study drug dispensing per protocol requirement. Performing the duties of a Project Manager, Regulatory Contact, and Clinical Coordinator as well as being the first point of contact for any research related communications as I am the sole research-only employee for the practice. -
Clinical ManagerAzidus Laboratories Ltd Oct 2016 - Feb 2017Green Bay, Wisconsin AreaI assisted a new startup company in developing and reviewing standard operating procedures (SOPs) in accordance with any applicable federal legislation and recommendations. Additionally, I researched the necessary equipment/supplies, as well as the associated expenses. I developed positive relationships with vendors in order to achieve the best results.Some highlights of my efforts to bring a positive outcome include:• Provided training to staff on the creation of SOPs, as well as created and reviewed training documents/work instructions. -
Sr. Certified Clinical Research CoordinatorAxis Clinicals Usa Apr 2014 - Sep 2016Dilworth, MnDuring this tenure, I coordinated with the main investigator to ensure that clinical research and related activities were carried out in accordance with federal regulations, policies, and procedures. I made sure that all essential participants in research projects had received the required training, in accordance with federal standards and sponsoring agency regulations and procedures. Apart from that, I interviewed coordinators and other support personnel.Among my key efforts to achieve a favorable outcome are:• Served as trainer/mentor to new staff members.• Responded to any audit findings and implement approved recommendations• Collected clinical trial data and ensured subject safety in accordance with GCP.• Supervised general study conduct; clinical research coordinators' preparation and data collecting support.• Acquired additional professional development through management training, ongoing education, and relevant experience. -
Reseach TechnicianNovum Pharmaceutical Research Services Jan 2014 - Apr 2014Fargo, North Dakota AreaAssisted Study Mangers with study conduct for dermatological studies. Screening potential study subjects. Performing chromameter, adhesion and irritation assessments as required per study protocol. -
Customs SpecialistInternational Trade Solutions Aug 2013 - Jan 2014Fargo, North Dakota AreaI ensured that all applicable trade laws were followed by shipping. In accordance with Customs' requests, I created customer invoices, e-manifest trips, and other papers. My major initiatives to produce a favorable result include:• Contacted shipping businesses to collect any necessary information as needed.
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Knowledge Management Data Entry ClerkRestaurant Technoology Services Oct 2011 - Jul 2013Fargo, North Dakota AreaHere, I helped the finance and contracts department make sure that all pertinent data was accurately and completely recorded. I wrote Knowledge Articles for usage by technicians.My Signature highlights of this role include:• Edited and formatted knowledge articles for usage by technicians.• Contacted Owner/Operators if needed to complete missing paperwork.
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Certified Clinical Research CoordinatorPracs Institute Oct 2009 - Aug 2011East Grand Forks, Mn And Fargo, North Dakota AreaMonitoring dermatological and Phase I studies ensuring subject safety. Collect, transcribe, maintain, and ensure the accuracy of study data in accordance with specific protocol while adhering to Good Clinical Practices and Standard Operating Procedures. Training staff members. Scoring skin blanching, assessing irritation and sensitization, scoring adhesion, study drug dosing, and performing chromameter readings during vasoconstriction and patch studies. -
Clinical Study Monitor I, Ii, And IiiPracs Institute Jan 2007 - Sep 2009East Grand Forks, MnMonitor studies ensuring subject safety. Collect study data, transcribe, maintain, and ensure the accuracy of case report forms. Collect lab specimens as required per protocol. Adhering to Good Clinical Practices and Standard Operating Procedures. Training staff members.
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Phlebotomist I, Ii, And IiiPracs Institute Jan 2005 - Jan 2007East Grand Forks, MnCollection of lab specimens as required per protocol and Good Clinical Practices. Collection of Electrocardiograms. Sample processing as required per protocol and Good Clinical Practices. Training new phlebotomists.
Melissa Sexton Education Details
Frequently Asked Questions about Melissa Sexton
What company does Melissa Sexton work for?
Melissa Sexton works for Care Access
What is Melissa Sexton's role at the current company?
Melissa Sexton's current role is Senior Study Start Up Manager.
What schools did Melissa Sexton attend?
Melissa Sexton attended Le Cordon Bleu College Of Culinary Arts, Northland Community And Technical College.
Who are Melissa Sexton's colleagues?
Melissa Sexton's colleagues are Gabriela Gallegos, Holly Dickens, Edward Olko, Fatima Sanchez, Hazel Villagrana, Aisha Cooper-Hill, Sherwin Younge.
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Melissa Sexton
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Melissa Rodriguez
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Melissa Sexton
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Melissa Sexton
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