MIA E. SHARPE

CareAccess

Cell: 407-***-****

Office:

Email: adzcx7@r.postjobfree.com

January, 2023

Education:

Sanford Brown Institute Cardiovascular Ultrasound Tech

**** ********* ** ******* ***ence

Orlando Vocational Tech Medical Assistant

1992

Professional Experience:

CareAccess Orlando, Fl

Clinical research Coordinator 1/2023-present

Assisting in screening patients, obtaining Informed Consent from the patient, maintaining patient charts organized

Formulate observations, note results in CRF/eCRF/Source documentation systems

Draw inferences about trial assessments and report on conclusions

Prepare lab specimens for delivery to reference laboratory

Ensure proper handling of specimens according to in-house/reference laboratory protocols

Ensure lab specimens are appropriately labeled with proper test(s) ordered, correct accession number, tube type, etc. required to perform necessary procedures

Provide research support by preparing trial assessments, analyzing data, perform comparative analyses from former experimental data

Notify lab processor of any issues with orders and/or lab specimens

Develop research papers for publication based on experimental results and analysis

APG Research, LLC Orlando, FL

Clinical Research Coordinator 02/2022 – 11/2022

Assisting in screening patients, obtaining Informed Consent from the patient, maintaining patient charts organized

Formulate observations, note results in CRF/eCRF/Source documentation systems

Draw inferences about trial assessments and report on conclusions

Prepare lab specimens for delivery to reference laboratory

Ensure proper handling of specimens according to in-house/reference laboratory protocols

Ensure lab specimens are appropriately labeled with proper test(s) ordered, correct accession number, tube type, etc. required to perform necessary procedures

Provide research support by preparing trial assessments, analyzing data, perform comparative analyses from former experimental data

Notify lab processor of any issues with orders and/or lab specimens

Develop research papers for publication based on experimental results and analysis

SIH Research – Mumtaz Kissimmee, FL

Clinical Research Coordinator 06/2019 – 01/2022

Obtained Informed Consent Forms, enrolled subjects into clinical trials where eligible

Scheduled/obtained patient information including medical history, EKG information and any biological samples as specified in each respective protocol

Formulated, prepared, and maintained source documentation while preparing patients for specific trial assessments as specified per the protocol

Assist Principal Investigator with patient examination and administration of investigational product

Collected and processed patient specimens for select diagnostic tests

Serves as liaison between physician and other business affiliates

Managed practice finances and inventory of office materials/equipment

Rheumatology Associates Orlando, FL

Clinical Research Coordinator 09/2015 – 05/2019

Received/logged each specimen received in EDC system with proper identification, collection dates and sample types

Formulated observations and made note of results of experiments

Reported on conclusion of experiments conducted

Prepared biological specimens for pick-up to reference lab and ensured proper handling according to in-house or reference laboratory protocols

Ensured all specimens sent out to reference labs were appropriately labeled with proper test(s) ordered, correct accession number, tube type, and number of types required to perform the required tests

Provided research support by preparing experiments, analyzing data, and performing comparative data analyses from previous experimental data

Research Experience:

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease. NCT03464097

An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease. NCT02513459

A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) NCT04277546

A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in). NCT03616821

A 6-Month, Multicenter, Double-Blind, Randomized, Flexible-Dose, Parallel-Group Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy. NCT03321526

A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type. NCT02446132

AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis. NCT03028740

A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma. NCT03769090

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease. NCT03467958

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease. NCT03464097

A Prospective, Multicenter, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (Protocol: LND3000) (NCT03887715)

A 12-Week, Multicenter, Randomized, Double-blind Trial Evaluating the Efficacy, Safety, and Tolerability of Fixed-Dose Brexpiprazole + Sertraline Combination Treatment in Adult Subjects with Post-Traumatic Stress Disorder (Protocol: 331-***-*****) (NCT04174170)

A Phase 2, Double-blind, Randomized, Placebo Controlled Study in Major Depressive Disorder (MDD) Participants Currently Treated with Antidepressant Therapy (Protocol: CLE100-MDD-201) (NCT04103892)

Phase 3, Multicenter, Randomized, Double-blind,Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant or the Treatment of Migraine (With or Without Aura) in Children and Adolescents 6 to <18 Years of Age (Protocol: BHV3000-311) (NCT04649242)

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder (Protocol: BHV4157-302) (NCT04641143)

A Multicenter, 48-week Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder (Protocol: BHV4157-209) (NCT04708834)

An Exploratory, Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder (Protocol: GWND19189) (NCT04745026)

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression (Protocol: 54135419TRD4005) (NCT04599855)

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy and an Open-labeled Long-term Safety Extension Treatment With Seltorexant (Protocol: 42847922MDD3001) (NCT04533529)

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER) (Protocol LND-300) (NCT03887715)

A Phase IV, Open-Label, Flexible-Dose Safety Trial Evaluating SPN-812 Administered With Psychostimulants in Children and Adolescents (6 to 17 Years of Age) (Protocol: 812P412) (NCT04786990)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Adolescents With Attention-deficit/Hyperactivity Disorder (Protocol: 405-***-*****) (NCT05257265)

A Phase 3, Multicenter, Open-label, Long-term Trial Evaluating the Long-term Safety and Tolerability of Once Daily Centanafadine Capsules in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD) (Protocol: 405-***-*****) (NCT05279313)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Children With Attention-deficit/Hyperactivity Disorder (ADHD) (Protocol: 405-***-*****)

A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY) (Protocol: MDD2020) (NCT05165394)

An 8-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Cariprazine in the Treatment of Pediatric Subjects (5 to 17 Years of Age) With Autism Spectrum Disorder (Protocol: M21-465) (NCT05439616)

A Phase 2a, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-1942 Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (Protocol: MK-1942-006) (NCT04663321)

The RECOVER sub-study, which leverages quantitative and credible research tools from Verily, will provide assessment measures for Depressive Episodes (Protocol: LND300) (NCT04753385)

A Phase 3, Randomized, Doubleblind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents 6 to <18 Years of Age (Protocol: BHV3000-315) (NCT05156398)

A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth) (Protocol: ALKS 3831-A312) (NCT05303064)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder (Protocol: ACP-103-06) (NCT05523895)

A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD). (Protocol: ML-004-002) (NCT05081245)

A Phase II Multicenter, Randomized, Double-Blind, 12-Week Treatment, 3-Arm, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) (Protocol: BP41316) (NCT04299464)

Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study (Protocol: COMP 401) (NCT05481736)

A Randomized, Double-Blind, Placebo-Controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Protocol: TV50717-CNS-30080) (NCT03813238)

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults with Tourette’s Disorder (Protocol: EBS-101-TD-301)

A Short-term Exploratory Study to Evaluate Safety, Tolerability and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to SSRI Monotherapy and Psychotherapy (Protocol: 42847922MDD1016) (NCT04951609)

Certifications:

2015 IV Certification 2021 Good Clinical Practice ICH E6, Revision 2

2021 IATA Dangerous Good Regulations 62nd Edition 2022 Registered Medical Assistant

Mia E. Sharpe Date

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