Kaitlyn Cobb

Kaitlyn.Cobb@researchsitesupport.com

Education

BS Public Health                       University of North Carolina                 2009

Skills and Competencies

CTMS (CRIO. REALTIME. COMPLION)

Data Entry and Query Resolution

EKG/ECG Collection

Informed Consent Process

IP Administration (oral + injection+ IV)

IP Inventory Control (IRT. accoutability temperature monitoring)

IRB + IBC Initial, Continuing, Termination Review Submission

Lab Collection

Lab Processing and Shipment

Medical History Collection

Patient Recruitment and Retention

Patient Stipend Tracking (Greenphire. CTPayer. Payment App)

Phlebotomy

Quality Control

Regulatory Site File Maintenance

SAE/Adverse Event reporting

Site Operations

Skill training and assessment of site staff

Source design and revision (paper and e-source)

Vendor Systems (iMedidata. Medpace. Endpoint. Perspectum. ERT. Oracle etc)

Vital Sign Collection

Professional Experience

 Objective Health                                                                                         Remote

Quality Control Data Entry Specialist                                    Jan/2024 – Aug/2024

Objective Health/NE GI Research Division                          Concord, NC

Clinical Research Coordinator                                                   Jun/2021 – Jan/2024

Nola Research Works                                                                              New Orleans, LA

Clinical Research Coordinator                                                   Aug/2019 – Jun/2021

Unified Women’s Clinical Research                                          Winston-Salem, NC

Clinical Research Coordinator                                                   Aug/2016 – Jun/2019

Women Under Study                                                                               New Orleans, LA

Clinical Research Coordinator                                                  Feb/2016 – Aug/2019

New Orleans Center for Clinical Research                            New Orleans, LA

Patient Recruiter & Marketing                                                     Feb/2015 – Feb/2016

Professional Training

Good Clinical Practice                                                                                  CITI

Dangerous Goods Shipping                                                                    Mayo Clinic

Research Experience

2024 - 89BIO-231 Quality Control Data Entry Specialist
BIO89-100-231 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX in Subjects with Severe Hypertriglyceridemia (SHTG)

2024 - AK-US-001-0105 Quality Control Data Entry Specialist
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of xxx in subjects with non-cirrhotic nonalcoholic steatohepatitis (nash)/metabolic dysfunction- associated steatohepatitis (mash) and fibrosis

2024 - AK-US-001-0107 Quality Control Data Entry Specialist
A phase 3, randomized, double-blind, placebo-controlled study Evaluating the safety and efficacy of xxx in subjects With non-invasively diagnosed nonalcoholic steatohepatitis (nash)/metabolic dysfunction-associated steatohepatitis (mash) And nonalcoholic fatty liver disease (nafld)/metabolic Dysfunction-associated steatotic liver disease (masld)

2024 - ABK464-105 Quality Control Data Entry Specialist
A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of xxxx once daily for induction Treatment in subjects with moderately to severely active ulcerative colitis

2024 - KAN-101-02 Quality Control Data Entry Specialist
A phase 1b open-label/ phase 2 double-blind placebo [1] controlled study for pharmacodynamic activity, Pharmacokinetics, safety and tolerability of xxx in Patients with celiac disease

2024 - MGL-3196-19 Quality Control Data Entry Specialist
A randomized double-blind placebo-controlled phase 3 Study to evaluate the effect of xxx on liver-related Outcomes in patients with well-compensated (child-pugh A) non-alcoholic steatohepatitis (nash) cirrhosis (maestro-nash outcomes)

2024 - K-001-201 Quality Control Data Entry Specialist
A phase 2, multicenter, placebo-controlled, randomized, double-blind, 48-week study to evaluate the efficacy and safety of combination therapy of xxx and xxx in patients with noncirrhotic nonalcoholic steatohepatitis (nash) with liver fibrosis

2024 - PFM064 Quality Control Data Entry Specialist
A clinical biospecimen collection to support biomarker Research

 2024 - NN9500-4656 Quality Control Data Entry Specialist
Efficacy and safety investigation of xxx co-administered with Semaglutide in subjects with non- alcoholic steatohepatitis: a dose-ranging, Placebo-controlled trial

2024 - RNLC3132 Quality Control Data Entry Specialist
Randomized, double-blind, placebo-controlled, multicenter Study to assess the efficacy and safety of xxx soluble Solid dispersion (ssd) tablets for the delay of encephalopathy Decompensation in cirrhosis (red-c)

2024 - SARO.20.002 Quality Control Data Entry Specialist
A phase 2b, prospective, multicenter, randomized, double-blind, placebo [1] controlled study to evaluate efficacy and safety of xxx in subjects with nonalcoholic steatohepatitis and fibrosis

2023 - AK-US-001-0103 Clinical Research Coordinator
A phase 2b, randomized, double-blind, placebo-controlled study Evaluating the safety and efficacy of xxx in subjects with compensated cirrhosis due to nonalcoholic Steatohepatitis (nash)

2023 - GO44296 Clinical Research Coordinator
Roche cancer screening collection study

2022 - GS-US-454-6075 Clinical Research Coordinator
A phase 2, randomized, double-blind, double-dummy, Placebo-controlled study evaluating the safety and efficacy of Semaglutide, and the fixed-dose combination of xxx and xxx alone and in combination, in subjects with Compensated cirrhosis (f4) due to nonalcoholic steatohepatitis

2021 - EDP-305-102 Clinical Research Coordinator
A Phase 2b Randomized, Double Blind, Placebo-Controlled, Multicenter Study Evaluating Safety and Efficacy of XXX in Subjects with Liver-Biopsy Proven Non-Alcoholic Steatohepatitis (NASH)

2021 - VK2809-202 (VOYAGE) Clinical Research Coordinator
A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of XXX Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects with Biopsy Proven Non-Alcoholic Steatohepatitis with Fibrosis

2021 - NN9931-4553 (ESSENCE) Clinical Research Coordinator
The effect of XXX in subjects with non-cirrhotic non-alcoholic steatohepatitis

2021 - BI 1404-0043 Clinical Research Coordinator
Multicenter, double-blind, parallel-group, randomized, 48 weeks, dose-ranging, placebo- controlled phase II trial to evaluate efficacy, safety and tolerability of multiple subcutaneous (s.c.) doses of XXX in patients with non-alcoholic steatohepatitis (NASH) and fibrosis.

2021 - SB2640-CLIN-007 Clinical Research Coordinator
A Phase 2b, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of XXX in Subjects with Nonalcoholic Steatohepatitis (NASH)

2021 - AK002-021 Clinical Research Coordinator
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX in Patients with Moderately to Severely Active Eosinophilic Duodenitis who have an Inadequate Response with Lost Response to, or were Intolerant to Standard Therapies

2021 - 02-GI-002 (ECLIPSE) Clinical Research Coordinator
Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode

2021 - BIO89-100-122 (ENLIVEN) Clinical Research Coordinator
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of XXX in Subjects with Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)

2021 - BIO89-100-002 Clinical Research Coordinator
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of XXX Administered Subcutaneously in Subjects with Nonalcoholic Steatohepatitis (NASH) or with Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

 2021 - 337HNAS20011 (NATiV3) Clinical Research Coordinator
A randomized, double-blind, placebo-controlled, multicenter, Phase 3 study evaluating long-term efficacy and safety of XXX in adult patients with non-cirrhotic non- alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

2019 - M14-234 Clinical Research Coordinator
A Study to Evaluate the Safety and Efficacy of XXX for Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis (UC)

2019 - M14-430 Clinical Research Coordinator
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of XXX in Participants with Crohn's Disease Who Completed the Studies M14-431 or M14-433

2019 - M14-431 Clinical Research Coordinator
A Study of the Efficacy and Safety of XXX Participants with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

2019 - M14-433 Clinical Research Coordinator
A Study of the Efficacy and Safety of XXX in Participants with Moderately to Severely Active Crohn's Disease

2019 - M14-533 Clinical Research Coordinator
A Study of the Efficacy and Safety of XXX in Participants with Ulcerative Colitis (UC)

2019 - MlS-991 Clinical Research Coordinator
A Study to Assess the Efficacy and Safety of XXX in Participants with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

2019 - M16-000 Clinical Research Coordinator
A Long-Term Extension Trial of XXX in Patients with Moderately to Severely Active Crohn's Disease

2019 - M16-006 Clinical Research Coordinator
A Study to Access the Efficacy and Safety of XXX, in Patients with Moderately to Severely Active Crohn's Disease

2019 - M16-066 Clinical Research Coordinator
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and Open-Label Extension Study of the Efficacy and Safety of XXX in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

2019 - M16-067 Clinical Research Coordinator
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of XXX in Subjects with Ulcerative Colitis

2019 - 16T-MC-AMAN Clinical Research Coordinator
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of XXX in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis

2019 - 16T-MC-AMBG Clinical Research Coordinator
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of XXX in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

2019 - 16T-MC-AMAM Clinical Research Coordinator
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat- Through Study to Evaluate the Efficacy and Safety of XXX in Patients with Moderately to Severely Active Crohn1s Disease

2019 - 16T-MC-AMAP Clinical Research Coordinator
A Study to Evaluate the Long-Term Efficacy and Safety of XXX in Participants with Moderately to Severely Active Ulcerative Colitis (Lucent 3)

2019 - 3152-301-002 Clinical Research Coordinator
A Phase 3 Study to Evaluate the Efficacy and Safety of XXX for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis

2019 - SERES-201 Clinical Research Coordinator
A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of XXX in Adults with Active Mild-to-Moderate Ulcerative Colitis

2019 - VMT-VT-1161-CL-017 Clinical Research Coordinator
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX Oral Capsules in the Treatment of Subjects with Recurrent Vulvovaginal Candidiasis

2019 - SCY-078-304 Clinical Research Coordinator
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral XXX Compared to Placebo in Subjects with Recurrent Vulvovaginal Candidiasis (VVC)

2019 - M16-283 Clinical Research Coordinator
Long-Term Safety Study of XXX in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women

2019 - M14-702 Clinical Research Coordinator
A Phase 3 Study to Evaluate the Safety and Efficacy of XXX in Combination with Estradiol/Norethindrone Acetate in Subjects with Moderate to Severe Endometriosis- Associated Pain

2019 - 2693-CL-0302 Clinical Research Coordinator
A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, followed by a Non- Controlled Extension Treatment Period, to Assess the Efficacy and Safety of XXX in Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause

2019 - J2X-MC-PYAB Clinical Research Coordinator
A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of XXX and XXX in Participants with Mild to Moderate COVID-19 Illness

2019 - J2X-MC-PYAH Clinical Research Coordinator
A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy with XXX in Participants with Mild to Moderate COVID-19 Illness (BLAZE-4)

2019 - OBE2109-18-002 Clinical Research Coordinator
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of XXX in Subjects with Moderate to Severe Endometriosis-associated Pain.

 
2019 - OBE2109-19-002 Clinical Research Coordinator
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of XXX Alone and in Combination with Add- back Therapy for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women

 
2019 - MWP-HPV-159 Clinical Research Coordinator
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening

2018 - ProVATE PT 103 Clinical Research Coordinator
Pilot Study for the Evaluation of the ProVATE (ProTIPI) Pessary Designs in the Temporary Management of Pelvic Organ Prolapse (POP) in Women

2018 - MVT-601-034 Clinical Research Coordinator
A Prospective Observational Study of Bone Mineral Density in Women with Uterine Fibroids or Endometriosis

2018 - MVT-601-3101 Clinical Research Coordinator
An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate XXX Administered with and Without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain

2018 - MVT-601-3002 Clinical Research Coordinator
An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate XXX Co-Administered with and Without Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids

2017 - IMPROVE-100 Clinical Research Coordinator
The study will observe and quantify shifts in colposcopy practice and outcome improvements inU.S. community-based cervical screening colposcopy examinations after the introduction of the DySIS colposcope with Advanced Cervical Scan

2016 - CDlOl.TP.2.01 Clinical Research Coordinator
A Phase 2, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of XXX Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

2016 - 18649 Clinical Research Coordinator
Multi-center, Open-label, Uncontrolled Study to Assess Contraceptive Efficacy and Safety of XXX During Extended Use Beyond 5 Years in Women 18 to 35 Years of Age Including a Subgroup Evaluation of Treatment Effect on Heavy Menstrual Bleeding.

2016 - SP304-20212 Clinical Research Coordinator
A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXX in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)

2016 - ALD403-CLIN-006 Clinical Research Coordinator
A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of XXX Administered Intravenously in Patients with Frequent Episodic Migraines

2016 - 16953 Clinical Research Coordinator
An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of XXX in Subjects with Uterine Fibroids Versus Standard of Care

2016 - GLK 1502 Clinical Research Coordinator
A 4 week Randomized double blind placebo controlled clinical trial study of efficacy and safety in estradiol tables, XXX and placebo in post-menopausal women with VVA.

2016 - AMAG-FER-IDA-304 Clinical Research Coordinator
A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of XXX Compared to Ferric XXX for the Treatment of Iron Deficiency Anemia (IDA)

2016 - AMG 181 Clinical Research Coordinator
A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of XXX in Subjects with Moderate to Severe Ulcerative Colitis

2016 - 20120296 Clinical Research Coordinator
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX in Migraine Prevention