Clinical Research Associate

Sandra Rosenberg

USA-California-Home-Based

Sr CRA II

Biography

Rosenberg, Sandra, RN, BA

Sr. Clinical Research Associate II

Long Beach, CA

Sandra Rosenberg has 21 years experience in a clinical research organization (CRO) as a Clinical Research Associate II, Clinical Field Assessor/Trainer, Senior Clinical Research Associate and Lead CRA in domestic/international trials. Sandra Rosenberg also has 17 years experience as a registered nurse and eight years experience as a study coordinator. Sandra Rosenberg has been instrumental in training/mentoring new CRAs as well as entry level CRAs.

Her therapeutic area experiences include:

CNS:

-ADHD; multiple studies

-MDD; one study

-Diabetic neuropathy; one study

-Parkinson's disease; two studies

-Alzheimer's disease; multiple studies

-Ophthalmology; several studies, wet AMD and diabetic retinopathy

-Pain; several studies

-MS; one study

Professional Experience

Sep 2001 - Nov2023 Syneos Health (formerly INC Research), Austin TX; position eliminated

Sr Clinical Research Associate II (SCRA retitled Apr 2017) Senior Clinical Research Associate

2001 - March, 2007

January 2009-present

-Expertise in Phases I through IV in a variety of therapeutic areas

-Experienced with Schedule II drug (narcotics) studies

-Nursing background in a variety of roles and facilities

-Well acquainted with electronic data capture and remote data entry systems as a monitor and coordinator

-Primary responsibility is site management and performance (including documentation) according to ICH guidelines (and country specific guidelines and government regulations), as well as FDA regulations (state and local laws), GCPs, and SOPs. Site management activities include all in-house and on-site monitoring for all visit types. Therapeutic focus: CNS (includes Ophthalmology) and Pediatrics Clinical Field Assessor

March 2007—January 2009

(position eliminated)

-Worked with the project teams to assess the quality of field Clinical Operations staff.

-Responded rapidly to resolve acute clinical/ project needs.

-Ensured CRAs are competent to conduct on-site monitoring visits according to INC Research Standard Operating Procedures, Work Instructions, internal business practices, study-specific protocols, Good Clinical Practice and ICH guidelines, and regulatory requirements.

-Performed on-site assessments of Clinical Operations staff. Therapeutic Experience

Analgesia - Fibromyalgia

- Headache, Migraine

- Pain

- Pain, Diabetic Peripheral Neuropathy

- Pain, Low Back

- Pain, Neuropathic

- Pain, Postherpetic Neuralgia

CNS Neurology - CNS Neurology - Attention Deficit Hyperactivity Disorder

- CNS Neurology - Cervical Dystonia

- CNS Neurology - Headache

- Rheumatoid Arthritis

- CNS Neurology - Transient Ischemic Attack

CNS Psychiatry - Anxiety

- Anxiety, General Anxiety Disorder

- CNS Psychiatry - Attention Deficit Hyperactivity Disorder

- CNS Psychiatry - Opioid Addiction

- Panic Disorder

- CNS Psychiatry - Smoking Cessation Addiction

Cardiovascular - Cardiovascular - Acute Ischemic Stroke

- Vascular Disease, Peripheral

Immunology /

Inflammatory

- Osteoarthritis

Infectious Disease - Immunization, Vaccinia

- Infection, Influenza

Neurology - Alzheimers Disease

- Epilepsy

- Multiple Sclerosis

- Neuropathy, Diabetic Peripheral

- Parkinson's Disease

- Seizure Disorders

- Stroke

Nutrition - Obesity

Oncology - Cancer, Lung

Ophthalmology - Diabetic Retinopathy

-wet AMD; two different protocols (both blinded). First study approximately 2020. Most recently participated in wet AMD study at the end of 2023

Other - Electronic Diaries

- Medidata EDC Rave (With Role)

CTMC

Psychiatry - Anxiety

- Anxiety, General Anxiety Disorder

- Cognitive Impairment

- Cognitive Impairment, Mild

- Depression

- Depression, Major Depressive Disorder

- Insomnia

- Insomnia, Transient

- Mood Disorders

- Panic Disorder

Respiratory - Chronic Obstructive Pulmonary Disease Skeletal Diseases - Osteopenia

- Osteoporosis

- Osteoporosis, Postmenopausal

- Spasm, Muscle

Women's Health - Women's Health - Inhibition of Pre-Term Labor Languages

English - Speaking, Reading, Writing

Additional Experience

- CRA Trainer/Assessor

- Dose Escalation

- Dose Ranging

- EDC-Other

- Fecal Bacteria

- IMPACT Experience

- IWRS

- InForm EDC

- Multiple Dose Safety

- Multiple Rising Dose

- Pharmacokinetic

- Phase 1 - Healthy Subjects

- Rave EDC

Professional Certifications & Licensures

RN license not current

Education

Colorado Christian College - United States

Bachelor - human resources

Barnes Hospital School of Nursing - United States

Registered Nurse - Nursing

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