April Morago

**** *. ****** ***

Denver, CO *****

303-***-****

adbqjr@r.postjobfree.com

Detailed-oriented and quality-driven Clinical Research Coordinator (CRC), Medical Assistant (M.A) with seventeen years’ experience in the medical field and seven plus years’ experience as a Clinical Research Coordinator, looking for a long term clinical research position with a reputable research site. Research and Clinical experience include Oncology research, Women’s health research, and Internal medicine. Involvement in Phase I-IV Clinical trials such as, breast, lung, brain, prostate and ovarian cancers. Sexual dysfunction, vasomotor symptom treatment, dyspareunia, weight loss, birth control, a verity of menopausal and oncology clinical trials. Academic achievements include 4.0 GPA and Dean’s List while furthering my education as a Medical Assistant. Hands on and work experience as a supervising Medical Assistant at two different medical facilities and a leader CRC position with a research site over the last 17 years.

QUALIFICATION HIGHLIGHTS:

• 7+ years’ experience as a clinical research coordinator.

• Experienced in Phase 1 and up Clinical trials. Oncology, women’s health and internal medicine.

• Managed multiple studies simultaneously at multiple sites around Colorado; Colorado Cancer Research Program offers over 90 Oncology trials to the Colorado Community, and extends out to Wyoming. Many studies ranging 4-10 years for each participant.

• Performing Informed Consent Process for clinical trials, in accordance with International Review

Board (IRB), Independent Ethics Committee (IEC), Ethical Review Board (REB) and Good

Clinical Practice (GCP) standards.

• Assisted with Quality Assurance Departments with Registration/Randomization process after eligibility criteria is reviewed and verified. Review Baseline and cycle completion for any corrections, missing source documents, data error, or other information required.

• Experience as a back office Medical Assistant/Supervisor, at two different medical practices. As well as a lead CRC role at a research site.

• Coordinate clinical trials for pharmaceutical companies and National Cancer Institution under supervision of the Principal Investigator. Communicate closely with representatives with various pharmaceutical companies, and multiple sites with Rocky Mountain Cancer Centers, and The Women’s Imaging Center, as well as other research partners.

• Interview and recruit patients for clinical trials, following protocol guidelines. Maintain all

Patient files, as well as patient retention.

• Responsible for drug accountability for each study. Communicate closely with study personnel, to

Ensure adherence to sponsor protocols.

• Maintain extensive patient contact, via telephone and written correspondence. Monitor patient

Follow-up visits record any adverse events, SAE’s, medication and health changes.

• Data collection for patient visits, examinations, and procedures.

Additional experience with various Vendors, EMR systems and Electronic data entry programs including, Inform, Datalabs, Oracle, eClincalOS, MedidataRAVE, EMR systems: OncoEMR, IKNOWMED, and EPIC. Vendors: BioClinica, Covance, PPD, ERT, Quintiles, ACM-Pivotal Central Laboratory

EDUCATION:

CONCORDE CAREER INSTITUTE Denver, CO

MEDICAL ASSISTING DIPLOMA 7/2003 GPA 4.0/Dean’s List

SOUTH HIGH SCHOOL Denver, CO

DIPLOMA 5/2001 GPA 3.4

COMPUTER SKILLS and CERTIFICATIONS/TRAINING:

Microsoft Word

Excel

Microsoft Outlook

IATA certified

CITI GCP Training completed OCT/2018

NIH Clinical Research Training completed OCT/2017

ACRP Member

WORK HISTORY:

DOWNTOWN WOMEN’S HEALTH

Clinical Research Coordinator

FEB2019-JAN2020

Recruiting, interviewing, and screening research subjects for various women’s health clinical trials.

Responsible for obtaining Informed Consent from research participants, maintaining source documents,

Protocol adherence, patient retention, and ensuring patient privacy protection. Collection of laboratory

Specimens such as, venipuncture, specimen processing and shipping. Obtaining ECG’s, data collection

And EDC entry and eCRF/CRF completion. Maintaining regulatory documents for ISF binders. IRB

Submissions for study start up and study closures.

COLORADO CANCER RESEARCH PROGRAM

Clinical Research Coordinator

OCT 2016- DEC2018

Recruiting, interviewing, and screening research subjects for various Oncology clinical trials at multiple research sites around Colorado.

Responsible for obtaining Informed Consent from research participants, maintaining source documents,

Protocol adherence, patient retention, and ensuring patient privacy protection.

Collection of laboratory Specimens such as, venipuncture, specimen processing and shipping. EDC entry and eCRF/CRF completion.

AE and SAE reporting to CTSU.

Registration and randomization on subject’s who meet eligibility criteria through OPEN (A process through the National Cancer Institution.

Chart review for Baseline and completed cycles for treatment trials, to verify information is accurate and meets protocol guidelines.

DOWNTOWN WOMEN’S HEALTH

Clinical Research Coordinator

JAN 2016-OCT 2016

Recruiting, interviewing, and screening research subjects for various women’s health clinical trials.

Responsible for obtaining Informed Consent from research participants, maintaining source documents,

Protocol adherence, patient retention, and ensuring patient privacy protection. Collection of laboratory

Specimens such as, venipuncture, specimen processing and shipping. Obtaining ECG’s, data collection. And EDC entry and eCRF/CRF completion. Maintaining regulatory documents for ISF binders. IRB

Submissions for study start up and study closures.

GENESIS CENTER FOR CLINICAL RESEARCH

Clinical Research Coordinator (Lead CRC)

MAY 2013 – NOV 2015

Recruiting, interviewing, and screening research subjects for various women’s health clinical trials.

Responsible for obtaining Informed Consent from research participants, maintaining source documents,

Protocol adherence, patient retention, and ensuring patient privacy protection. Collection of laboratory

Specimens such as, venipuncture, specimen processing and shipping. Obtaining ECG’s, data collection

And EDC entry and eCRF/CRF completion. Maintaining regulatory documents for ISF binders. IRB

Submissions for study start up and study closures.

MEDICAL ONCOLOGY ASSOCIATES OF SAN DIEGO

Back Office Medical Assistant Supervisor

FEBURARY 2011- MAY 2013

Assist nurses in infusion center, injections (Drawing up medication as well as mixing medication for

injection/vial uses), phlebotomy, assist in minor procedures, prescription refill authorizations, cleaning

And stocking exam rooms. Oversee all duties of other medical assistants. Cleaning and sterilizing surgical

Instruments.

COLUMBINE FAMILY PRACTICE Littleton, CO

Back Office Medical Assistant Supervisor

SEPTEMBER 2003- FEBURARY 2011

Guiding patients to examination rooms for routine doctor visits. Collecting vital signs, injections,

Phlebotomy, assist in minor procedures, prescription refills and authorizations, cleaning and stocking

Exam rooms. Notifying and explaining laboratory/radiology reports to patients. Oversee all duties of other Medical assistants.

CLINICAL TRIAL EXPERIENCE:

Protocol - NN9068-3697: Dual Action of XXX and Insulin XXX in Type 2 Diabetes; A trial comparing

the efficacy and safety of insulin XXX/XXX, insulin XXX and XXX in subjects with type 2 diabetes

Sponsor: Novo Nordisk

Protocol - 27018966IBS3001: A Randomized, Double-blind, Placebo-Controlled, Phase III Study to

Evaluate the Efficacy, Safety, and Tolerability of XXXX in the Treatment of Patients with Diarrhea-

Predominant Irritable Bowel Syndrome

Sponsor: Furiex Pharmaceuticals

Protocol - PR-05812: A Randomized, Multicenter, Double-Blind, Vehicle-Controlled, Study to

Evaluate the Safety and Efficacy of XXXX in Post-Menopausal Women

Sponsor: Warner Chilcott

Protocol - PR-08112: A Randomized, Multicenter, Double-Blind, Vehicle-Controlled, Study to

Evaluate the Safety and Efficacy of XXXX in Post-Menopausal Women with Dyspareunia

Sponsor: Warner Chilcott

Protocol - MK-8175A-022: A phase III, randomized, open-label, active-controlled, multicenter trial to

study the contraceptive efficacy and safety of the commercial batch of oral tablets XXXX in healthy,

sexually-active women aged 18-50 years

Sponsor: Merck Sharpe & Dohme Corp.

Protocol – MK-4618-008-11: A 52 week Extension to: A Phase IIb Randomized, Placebo and Active

Comparator (XXX) -Controlled, 2-Part Clinical Study of the Efficacy and Safety of XXX in Patients with

Overactive Bladder.

Sponsor: Merck Sharpe & Dohme Corp.

Protocol: 71342602: A Randomized, Investigator-Blind, Placebo-Controlled, Parallel Design, Multiple-

Site Study Comparing Sun Pharmaceutical Industries, LTD XXXX Vaginal Tablets with XXXX

(Estradiol) Vaginal Tablets in the Treatment of Atrophic Vaginitis

Sponsor: Novum Pharmaceuticals

Protocol: AR08.100: A Randomized, Double-Blind, Placebo-Controlled, Forced Titration, Dose-

Ranging Study of XXXX in the Treatment of Vasomotor Symptoms (VMS) in Menopausal Females: A

proof-of-concept Study

Sponsor: Arbor Pharmaceuticals

Protocol: ERC-238: Intravaginal Prasterone (XXXX) against vulvovaginal atrophy associated with

menopause (Placebo-controlled, double-blind and randomized phase III study)

Sponsor: Endoceutics

Protocol: BAY 15788: A randomized, parallel-group, double-blind, placebo-controlled, multi-center

study to assess the efficacy and safety of BAY XXXXXX in subjects with uterine fibroids over 3 months

Sponsor: Bayer Health Care

Protocol: ATI-CL23

A single-arm, open label, multicenter, Phase 3 study of the contraceptive efficacy, safety, and tolerability

of the XXXXX-XX transdermal contraceptive delivery system (TCDS)

Sponsor: Parexel International LLC

Protocol: RFX-VAG/003/2012

A Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, and Safety, and

tolerability of XXXXXXXXX Vaginal Tablets in the Treatment of Bacterial Vaginosis

Sponsor: Alfa Wassermann

Protocol: BMT-301

A Phase 3, Multicenter, Double-Blind, Placebo-controlled, Parallel-group trial with an Open-label

Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Administered

XXXXXXXXXXXXX in Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD)

(with or without Deceased Arousal)

Sponsor: Palatin Technologies, INC

Protocol: COL-1077-07

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a

Single Dose of XXX-XXXX in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy

Sponsor: Juniper Pharmaceuticals

Protocol: VMT-VT-1161-CL-006

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the

Efficacy and Safety of XX-XXXX Oral Tablets in the Treatment of Patients with Recurrent Vulvovaginal

Candidias

Sponsor: Viamet Pharmaceuticals, Inc

Protocol: MTC-001

Solubilizied Metronidazole And/oR Terconazole Gels Intra-vaginal Efficacy and Safety (SMART GIVES)

Phase III

Sponsor: Curatek Pharmaceuticals, LLC

Protocol: MK-8342B-061-00

A Phase 3, single arm, clinical trial to study the contraceptive efficacy and safety of the XX-XXXXX

Vaginal ring in healthy women 18 years of age and older, at risk for pregnancy

Sponsor: Merck Sharpe & Dohme Corp.

Protocol: CF111/303

A Pivotal Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability and Pharmacokinetics of LF111 (XXXXXXXXXXX 4.0mg) During 13 Cycles

Sponsor: SCOPE

Protocol: 71436001

A Randomized Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of XXXXXXXX Vaginal Cream USP, 0.01% (TEVA Pharmaceuticals, USA) to XXXXXXX Vaginal cream USP, 0.001% (Warner Chilcott) in the Treatment of Atrophic Vaginitis

Protocol: 71462901

A Randomized Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of XXXXXXXX Vaginal Cream USP, 0.01% (Alvogen Pine Brooke LLC) to XXXXXXX Vaginal cream USP, 0.001% (Warner Chilcott) in the Treatment of Atrophic Vaginitis

Protocol: 1517I0231

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients with Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) due to Menopause

Protocol: NRG-GY004

A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Protocol: S1007 (CTSU/SWOG)

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial RX for Positive Node, Endocrine Responsive Breast Cancer.

Protocol: EA1131

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

Protocol: EA1151 (TMIST)

Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Protocol: EA1141

COMPARISON OF ABBREVIATED BREAST MRI AND DIGITAL BREAST TOMOSYNTHESIS IN BREAST CANCER SCREENING IN WOMEN WITH DENSE BREASTS

Protocol: NRG-BR003

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Protocol: AFT-05 (PALLAS)

PALBOCICLIB COLLABORATIVE ADJUVANT STUDY: A RANDOMIZED PHASE III TRIAL OF PALBOCICLIB WITH STANDARD ADJUVANT ENDOCRINE THERAPY VERSUS STANDARD ADJUVANT ENDOCRINE THERAPY ALONE FOR HORMONE RECEPTOR POSITIVE (HR+) / HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE EARLY BREAST CANCER

Protocol: S1320

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma

Protocol: S1207

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer.

Protocol: A011401

RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF WEIGHT LOSS IN ADJUVANT TREATMENT OF OVERWEIGHT AND OBESE WOMEN WITH EARLY BREAST CANCER

Protocol: A011502

A randomized phase III double blinded placebo-controlled trial of aspirin as adjuvant therapy for node-positive HER2 negative breast cancer: The ABC trial

Protocol: S1416

PHASE II RANDOMIZED PLACEBO-CONTROLLED TRIAL OF CISPLATIN WITH OR WITHOUT ABT-888 (VELIPARIB) IN METASTATIC TRIPLE-NEGATIVE BREAST CANCER AND/OR BRCA MUTATION-ASSOCIATED BREAST CANCER

Protocol: S1418

A RANDOMIZED, PHASE III TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MK-3475 (PEMBROLIZUMAB) AS ADJUVANT THERAPY FOR TRIPLE RECEPTOR-NEGATIVE BREAST CANCER WITH 1 CM RESIDUAL INVASIVE CANCER OR POSITIVE LYMPH NODES (YPN+) AFTER NEOADJUVANT CHEMOTHERAPY

Protocol: E3A06

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma.,

Protocol: MNGX-102

A Randomized Double Blinded, Placebo Controlled Phase 1b Study to Assess the Safety and Effect of Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; Filgrastim) on Hot Flashes and other Vasomotor Symptoms of Menopause in Postmenopausal Women

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