Melissa Sexton Email & Phone Number

Yuma, Az, Us

United States

I 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.

United States

During 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.

United States

During 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.

Fargo, North Dakota Area

Assisted 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.

Green Bay, Wisconsin Area

I 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.

Dilworth, Mn

During 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.

Fargo, North Dakota Area

Assisted Study Mangers with study conduct for dermatological studies. Screening potential study subjects. Performing chromameter, adhesion and irritation assessments as required per study protocol.

Fargo, North Dakota Area

I 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.

Fargo, North Dakota Area

Here, 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.

East Grand Forks, Mn And Fargo, North Dakota Area

Monitoring 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.

East Grand Forks, Mn

Monitor 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.

East Grand Forks, Mn

Collection 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.

Education record

Education record