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Chicago-based Sr Clinical Research Associate

Location:
Chicago, Illinois, 60620, United States
Posted:
March 16, 2011

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ANGELA M. PINKNEY

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CHICAGO, IL 60620 (773) ***-****

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SUMMARY OF CLINICAL EXPERIENCE

Ten years experience in clinical trial monitoring, including study initiation through closeout. Provide on-site clinical trial monitoring and full site management at investigational sites in the conduct of Phase II-IV clinical trials. Recruited and trained investigators and site staff, assuring investigator integrity through proper monitoring and adherence to ICH and GCP guidelines. Extensive experience with various electronic systems, including: EDMS, CTMS, InFORM, Medidata, eTrials, Oracle Clinical/MACRO, eCaselink

Other clinical responsibilities include Remote Trial Master File Reconciliation:

• Responsible for executing assigned tasks to ensure project deliverables are met.

• Maintain internal metrics based on the established guidelines.

• Perform eTMF Review and QC activities using the Sponsor systems and tools.

• Confirm Presence of Essential Documents per study utilizing the TMF Essential Documents List.

• Review relevant Sponsor systems (including EDMS) to locate required documents.

• Use Essential Document list guidance to determine whether or not a document is applicable to and therefore required for each study.

• Perform relational QC amongst documents where applicable.

• Identify any documents as “missing” once all available systems have been reviewed.

• Provide an inventory listing any missing docs and documents with discrepancies.

• Perform QC on all studies including country, protocol and center -level documents.

THERAPEUTIC EXPERIENCE

• Cardiology: CABG, Hypertension, Coronary Stent, Peripheral Artery Disease

• CNS: Incontinence, Schizophrenia, Neuropathy, Sleep Apnea, Major Depressive Disorder

• Endocrinology: Obesity, Diabetes, Polycystic Ovarian Syndrome

• Gastrointestinal: Opioid-based Constipation, GERD, Irritable Bowel Syndrome

• Immunology/Anti-Infective: Rheumatoid Arthritis, Pediatric Vaccines, Hepatitis, Common Cold

• Medical Device: CABG, Coronary Stent

• Oncology (co-monitoring only)

• Respiratory, Asthma/Allergy: Sinusits, Rhinitis, Pediatric nasal spray, Nasal Polyps, Conjunctivitis, Pharyngitis

• Women’s Health: Infertility, Endometriosis, Uterine Fibroids, Urinary Incontinence, PCOS

EXPERIENCE

Independent Consultant

12/03-present Senior Clinical Research Associate/Lead Clinical Research Associate

CNS/Psychology

A phase III, multi-center, randomized, 3-month, double-blind,

parallel-group, placebo-controlled study to evaluate efficacy and

safety of XXXX in stable patients with sub-optimally controlled

symptoms of schizophrenia treated with antipsychotics, followed by a

9-month double blind treatment period.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXXX Evaluating Time to Relapse in Subjects With Schizoaffective Disorder

A phase III, randomized, double-blind, parallel-group, placebo-controlled, fixed-dose study comparing the efficacy and safety of 2 doses of XXXX in acute treatment of Adults with major depressive disorder

Cardiology

A Phase IIB, double-blind, randomized, placebo-controlled, study assessing efficacy of XXXX, a CETP inhibitor, on progression or regression of Carotid Artery Disease using Carotid MRI and FDG-PET/CT technique in patients with coronary heart disease (CHD) including patients with other CHD risk factors such as diabetes and peripheral arterial disease.

Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP): A Multicenter, Randomized, Open-label, 2-Arm Parallel Group Study to Evaluate the Efficacy of Moderate Vs. Aggressive Antihypertensive Therapy with XXXX and XXXX to Reduce Blood Pressure and Plasma hsCRP levels in Patients with Stage 2 Hypertension

The XXXX Carotid Stent System: A Post Market Approval Evaluation Study In Conjunction with the XXXX Embolic Protection System

An Evaluation of the Efficacy and Safety of Different Doses of XXXX in the Reduction of Blood Loss in Subjects Exposed to Cardio-Pulmonary Bypass during primary Coronary Artery Bypass Graft (CABG) surgery

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Arm Study to Assess the Long-Term Effects of XXXX V. Placebo Administered Orally to Patients with Intermittent Claudication Secondary to Peripheral Artery Disease

Gastroenterology (GI)

Phase III, Multicenter, Randomized, Placebo-controlled, Double-blind study of the Safety and Efficacy of XXXX in Patients with Opioid-induced Bowel Dysfunction

A randomized, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of XXXX in patients with active Gastroesophageal Reflux Disease (GERD)

Oncology (co-monitoring)

Randomized, phase III trial of XXXX in patients with squamous cell lung cancer

A Phase II Double-Blind, Randomized, Multi-center Study of XXXX in Subjects with Advanced or Metastatic Breast Cancer

Asthma/Allergy/Respiratory

A Phase 3 Double-Blind, Randomized, Multi-center Study of the Efficacy and Safety of 200 mcg BID XXXX vs. Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis

Pilot Polysomnography Study in Subjects With Seasonal Allergic Rhinitis Who Report Sleep Disturbances and Daytime Somnolence

Pilot Efficacy and Safety Field Trial of XXXX Administered Concomitantly With XXXX, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip

Safety Study of XXXX Nasal Spray.

Efficacy and Safety of Combination XXXX vs. Pseudoephedrine and Placebo in the Treatment of Subjects with Seasonal Allergic Rhinitis

Crossover Study of the Decongestant Effect of XXXX Compared With Placebo and XXXX as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber

A two-week, randomized, double-blind study assessing the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose in adult subjects (> 18 years of age) with mild to moderate asthma, receiving XXXX x 2 actuations twice daily or XXXX x 2 actuations twice daily

A Randomized, Double- Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of XXXX for Symptomatic Therapy in Patients with Acute Upper Respiratory Tract Infections Who Seek Treatment

Women’s Health/Endocrinology

A phase III, randomized, double-blind, active-controlled, non-inferiority clinical trial to investigate the efficacy and safety of a single injection of XXXX to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference.

Pilot Polysomnography Study in Subjects with Polycystic Ovarian Syndrome (PCOS) and Sleep Apnea

A Study to Characterize the Properties, Safety, and Tolerability of XXXX in PCOS subjects with Metabolic Syndrome X

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of XXXX in Endometriosis

A Phase III, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of XXXX Versus Placebo in Subjects with Uterine Leiomyomata

A Multicenter, Randomized, Double-Blind Placebo-Controlled Study Comparing the Safety and Efficacy of XXXX and Placebo in Obese Subjects

A phase III, randomized, double-blind study to evaluate the efficacy and safety (including bone density assessments) of XXXX versus placebo in subjects with uterine leiomyomata

Long Term Monitoring of Safety in Subjects Treated with XXXX for Stress Urinary Incontinence and XXXX Long-Term Monitoring of Safety in Female Subjects Treated with XXXX for Stress Urinary Incontinence

Assistant Clinical Team Lead, conduct site screening, initiation, monitoring and close-out visits for Phase II endometriosis study

Assistant Clinical Team Lead, conduct site screening, initiation, monitoring and close-out visits for double-blind phase III study of the role of Insulin Resistance in Polycystic Ovarian Syndrome (PCOS)

Immunology

A randomized, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of XXXX in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.

A phase II, randomized, double-blind trial of the safety, tolerability and immunogenicity of XXXX vaccine in healthy infants

A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of XXXX in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.

A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of XXXX in Combination with Ribavirin Compared with XXXX in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1.

Medical/Technical Writing

Assist with the review and editing of study protocols and amendments

Assist with the writing, review, editing and approval of informed consents (IC)

Full Site Management

Enact post-audit Corrective Action Plans

Conduct site selection, initiation, monitoring and close-out visits

Training of Investigators and site staff

Assist with the review and submission of regulatory and IRB documentation

CRO training and management

Manage study budgets and contracts for study sites, vendors and CRO

Conduct query resolution

Created SAE database

Responsible for SAE tracking

QUINTILES, Chicago, IL

11/00-12/03 Clinical Research Associate

Conducted monitoring and close-out visits for a multi-center, double-blind Phase III study for a pediatric vaccine

A randomized, Phase III, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of XXXX in Pediatric Subjects with Persistent Asthma

A randomized, Phase III, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of XXXX in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis

Biomechanical Effects of XXXX on Bladder Function and Sphincter Resistance During the Emptying Phase and on Urethral Function During the Filling Phase of the Micturition Cycle in Women with Pure Genuine Stress Incontinence

Treatment of Peripheral Neuropathy in Diabetes Patients

Performed site selection visits for IBS, Asthma, Pharyngitis and Conjunctivitis studies

Experienced with electronic data capture and remote data entry (Web-based)

Perform training/mentoring visits for new hires and recently promoted CRAs

CLINICAL TRIALS INTERNSHIP, University of Chicago

2/00-5/00 Therapeutic Areas

Endocrinology

Asthma/Allergy

Renal

CERTIFICATIONS

Association of Clinical Research Professionals September, 2006

EDUCATION

PTI INTERNATIONAL March, 2007

Conducting Internal Audits

UNIVERSITY OF CHICAGO, GRAHAM SCHOOL May, 2000

Clinical Trials Management Program (includes the following courses)

Drug Development Process

Good Clinical Practices

Fundamentals of Site Management

Fundamentals of Clinical Monitoring

Statistical Concepts for Clinical Research

Writing for Clinical Research

Project Management in Clinical Research

SAINT XAVIER UNIVERSITY OF CHICAGO, Chicago, IL May, 1997

Bachelor of Arts, English

Bachelor of Science, Biology

RICHARD J. DALEY COLLEGE, Chicago, IL August, 1993

Associate of Science, Biology

AWARDS/ASSOCIATIONS

Drug Information Association (member)

Association of Clinical Research Professionals (member)

References are furnished upon request



Contact this candidate