Michelle Storms Email & Phone Number

Wentzville, Mo, Us

Research Nurse Navigator for Vanderbilt Coordinating Center.

United States, Remote

St. Louis, Mo

• Recruit, screen and enroll subjects for research trials• Conduct Informed Consent process with subject prior to any study related procedures• Conduct subject visits according to protocol; perform procedures as required- collect medical & surgical history, obtain vital signs; ECGs; patient education; study medication instruction, prep and administration; schedule all required appointments and required testing; complete all EDC entry; answer all queries• Collect all Adverse Events and Serious Adverse Events; continue follow-up and update sponsor; complete all reports• Laboratory Specimen collection, processing and shipment; Review all lab results with Investigator and follow up as needed• Creation and completion of Source Documents; Accountability of Investigational Product; • IRB submissions, Study start up, Continuing review, Safety reporting, Closeout of studies; Maintain Regulatory binders• Interact with sponsor/monitors for study purposes

St. Louis, Mo

• CRC for a Site Management Organization (SMO)- multiple offices, various therapeutic areas• Performed Subject Visits as per protocol- Consent, Screening, Randomization etc• Performed: Subject assessments, Vital Signs, ECGs, specimen collection, IV insertions; assisted with procedures such as colonoscopies; IP Accountability• Monitored all subject lab results; Provided subject instruction and education; monitored for all AE and SAEs; collected and submitted all AE and SAE data • Created & Completed all sources; completed CRFs & data entry; • Proficient at various EDC systems and multiple vendors for various study suppliers• Interacted with PI/SubI (physicians) continuously during study with study plan, study update, subject updates, etc• Performed QC of subject charts; Maintained/reviewed regulatory documents• Managed each study from start-up to close; attended all sponsor meetings• Phase II-III and Device

St. Charles, Mo

• New company bought old Cetero/PRACS facility through bankruptcy and hired to help start up procedures. Assisted with SOP development, office and clinic set up, planning, and organizing equipment & supplies. • Performed subject Screening visit and assessments- Consent, Screening• Performed: Subject assessments, Vital Signs, ECGs, specimen collection, IV insertion as required• Monitored all subject lab results; Provided subject instruction and education; AE & SAE data collection and monitoring• Completed all sources & CRFs; Maintained/reviewed regulatory documents• Interacted with PI/SubI (physicians) continuously during study with study plan, study update, subject updates, etc• Performed QC of subject packets• Phase I, Generics

St. Charles, Mo

• Performed Feasibility Assessments for Potential Studies; Assisted with Budget Review, as needed• Managed each study from start-up to close; • Lead of daily operational tasks for Innovator Team members • Scheduled & Attended all Sponsor visits- SIV, IMV, Close out Visits• Performed: subject visits and assessments, Vital Signs, ECGs, specimen collection, IV insertion ; Consent, Screening, Randomization, Follow-up & End of Study/Termination Visits; Dispensed & Collected Study Product; Performed Study Product Accountability; AE & SAE collection• Provided education to study subjects regarding study specific items such as: study conduct, study product, diary completion, dietary restrictions, questionnaires, etc. Monitored all subject lab results• Created & Completed all sources; completed CRFs; Maintained regulatory documents• Interacted with PI/SubI (physicians) continuously during study with study plan, study update, subject updates, etc.• Position eliminated then company closed due to bankruptcy

Chesterfield, Mo

• Clinical Research Coordinator for Women’s Health Private Medical Practice• Performed subject visits - Consent, Screening, Randomization, Follow-up & End of Study/Termination Visits • Performed subject assessments, Vital Signs, ECGs, specimen collection, IV insertion • Provided education to subjects regarding study specific items such as: study product, diary completion, dietary restrictions, questionnaires, etc• Monitored all subject lab results• Completed all Source Documents & CRFs; Maintained regulatory documents• Interacted with Sponsors & monitors• Interacted with PI/SubI on daily basis with study plan, update & subject status• Performed QC on subject charts• Worked here part-time while Cetero slow• Phase II-IV

St. Louis, Mo

• Office Nurse & Clinical Research Coordinator for Private Plastic Surgery Office• Assisted Physician with various Plastic Surgery Patients in an office setting- assisted with prescriptions, changed dressings, removed sutures, scheduled appts, patient education on all different procedures offered & specific instructions on scheduled procedures, etc• Assisted with surgeries, assisted &/or performed laser procedures, office procedures, drew subject labs, obtained V/S, took subject pictures; injected Botox/Fillers • Recruited subjects for studies• Conducted all subject outpatient research visits• Provided education to subjects regarding study specific items such as: study product, diary completion, dietary restrictions, questionnaires, etc• Monitored all subject lab results; Completed all Source & CRFs; Maintained regulatory documents• Interacted with Sponsors & monitors• Interacted with PI/SubI on daily basis with study plan, update & subject status• Performed Study Feasibility, Questionnaires & Budget review• Phase II-IV

Bsn, Registered Nursing/Registered Nurse

Associate'S Degree, Registered Nursing/Registered Nurse