Krystal Sanders

Seasoned Clinical Research Coordinator with a proven track record at Care Access, adept in Good Clinical Practices and patient recruitment. Excelled in enhancing patient safety and study accuracy, showcasing exceptional interpersonal communication and meticulous attention to detail. Demonstrated expertise in trial management and data evaluation, ensuring compliance and quality assurance in fast-paced environments. Results-driven research professional prepared for challenges of overseeing clinical studies. Proven track record of managing complex projects and ensuring compliance with research protocols. Known for fostering team collaboration and adapting to evolving project needs, while excelling in data management and regulatory adherence.

• National Registered Certified Medical Assistant
• Georgia Certified Nursing Assistant
• Florida Certified Nursing Assistant
• Certified Phlebotomy Technician
• Electrocardiogram Tech (EKG)
• Patient Care Tech
• Cardiopulmonary Resuscitation (CPR)
• NIDA GCP
• Syneos IATA

Black Women In Clinical Research (BWICR)

ACNE ROSACEA DIABETES MELLITUS TYPE I DIABETES MELLITUS TYPE II HYPOGONADISM SECONDARY HYPOGONADISM BONE DENSITY CONSTIPATION IRRITABLE BOWEL SYNDROME ULCERATIVE COLITIS | CROHN’S DISEASE ENDOMETRIOSIS UTERINE FIBROIDS ALZHEIMER’S DISEASE | MILD COGNITIVE IMPAIREMENT | DEMENTIA MIGRAINE OSTEOARTHRITIS LOWER BACK PAIN ASTHMA ATTENTION DEFICIT HYPERACTIVITY DISORDER MAJOR DEPRESSION DISORDER NOCTURIA OVERACTIVE BLADER

DERMATOLOGY:

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of

Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects with Facial Acne Vulgaris

AN OPEN-LABEL, LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY OF CORTEXOLONE 17α-PROPIONATE (CB03-01) CREAM, 1% APPLIED TWICE DAILY IN SUBJECTS WITH ACNE VULGARIS

A Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Local Tolerability of DFD-03 (tazarotene) Lotion, 0.1% compared to Tazorac® (tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris for 12 Weeks

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects with Acne Vulgaris

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY, COMPARING AZELAIC ACID FOAM 15% (TARO PHARMACEUTICALS U.S.A., INC.) TO FINACEA® (BAYER HEALTHCARE

PHARMACEUTICALS INC.) AND BOTH ACTIVE TREATMENTS TO A PLACEBO CONTROL IN THE TREATMENT OF MODERATE FACIAL ROSACEA

ENDOCRINOLOGY:

A Randomized, Multi-center, Double-Blind, Parallel-Group Clinical Study Comparing the Efficacy and Safety of MYL-1501D Produced by Two Manufacturing Processes in Type 1 Diabetes Mellitus Patients”

A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D with NovoLog® in Type 1 Diabetes Mellitus Patients

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of

Long-term Treatment with BELVIQ (lorcaserin HCl) on the Incidence of Major Adverse

Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight

Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors

Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity and type 2 diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects without or with Type 2 Diabetes

Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® both in Combination with Insulin Degludec with or without Metformin in Adults with Type 2 Diabetes (onset® 9)

A Phase IIb multicentre, double-blind, dose-ranging, randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism

A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

Testosterone Replacement therapy for Assessment of long-Term Vascular Events and efficacy ResponSE in hypogonadal Men (TRAVERSE) Study

A 6 month, double-blind safety extension study of MBGS205 evaluating the effects of long term treatment with BGS649 on bone mineral density

GASTROENTEROLOGY

A Prospective, Randomized, Multi-center, Single-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding

Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients with

Diarrhea-predominant Irritable Bowel Syndrome

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's

Disease (AIDA)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as

Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307)

GYNECOLOGY:

Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain

A randomized, double-blind, placebo-controlled, phase 2 trial assessing the efficacy, safety and dose-response of quinagolide extended-release vaginal rings administered sequentially for 8 menstrual cycles in women with moderate to severe endometriosis related pain.

A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the

Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women

Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids

A Phase 3, multicentre, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of daily oral administration of OBE2109 alone and in combination with add-back therapy for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

A Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone

Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women

NEUROLOGY:

A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for

Prognosis of Risk of Developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI due to AD in Cognitively Normal

Subjects (IND #112,403)

Tolerability, Pharmacokinetics, and Efficacy of MP-101 in the Treatment of Psychosis in Patients with Alzheimer’s Disease

A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

A Blinded Long-term Extension Study to Evaluate the Safety and Efficacy of Pioglitazone (AD-4833 Sustained Release 0.8 mg Daily) to Slow the Progression of Cognitive Decline in Subjects Who Have Completed the AD-4833/TOMM40_301 Study

With Diagnosis of MCI Due to Alzheimer Disease. AD-4833/TOMM40_303 Extension Study of the Safety and Efficacy of Pioglitazone to Slow Cognitive Decline in Subjects with MCI due to Alzheimer Disease. (IND #112,403)

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients with Mild to Moderate Alzheimer’s Disease (IND #133281)

An Open-label Long term Safety Study of Lasmiditan (200 mg and 100 mg) in the Acute Treatment of Migraine

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability of Oral Atogepant For The Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)

A Phase 3, Multicenter, Open-Label 40-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Episodic Migraine

ORTHOPEDICS:

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED,

MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF

SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH

OSTEOARTHRITIS OF THE HIP OR KNEE

PAIN:

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE CONTROLLED,

MULTICENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFICACY AND

SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

PULMONOLOGY:

A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma.

PSYCHIATRY:

A Multicenter, Dose-Optimized, Open-Label Safety Study with KP415 in Children with Attention-Deficit/Hyperactivity Disorder

A phase 3, randomized, double-blind, placebo-controlled, parallel group, adult workplace environment study to evaluate the safety and efficacy of prc-063 compared to placebo in adults diagnosed with adhd

“Dasotraline (2mg) in Children Aged 6 to 12 Years with Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety in a Laboratory Classroom Setting”

Open-Label Extension Study to Evaluate the Long- Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects with Attention Deficit/ Hyperactivity Disorder (ADHD) in Conjunction with Standard ADHD Treatment

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients with Attention Deficit/Hyperactivity Disorder (ADHD).

A Randomized, Double-Blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relaspe in Patients with Major Depressive Disorder.

UROLOGY:

"A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, with Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia due to Nocturnal Polyuria in Adults"

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects with Overactive Bladder (OAB)

VACCINES:

Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection