JOHANNA SALOM, BS, CCRC, CCRA

Baytown, TX ad06ob@r.postjobfree.com

972-***-****

https://www.linkedin.com/in/johanna-salom/

I am an experienced Clinical Trial Manager who has been working in clinical trials research since high school where I began at the ground floor obtaining ECGs, a phlebotomy certification and recording on old-fashioned 3-page NCR CRFs. Since then, I have accumulated extensive experience in the clinical research industry gained from key roles in leadership, conflict resolution, transition management and technical proficiency supporting cross functional teams. I have worn the study coordination, QA/ QC Compliance, monitoring, study team management hats and developed policies and procedures across the gamut. Successfully navigating them all while constantly learning new skills, systems and also helping to roll out innovative changes as a SME when needed.

Authorized to work in the U.S. for any employer (U.S. Citizen)

LEO Pharma, Inc. Madison, NJ - LEO Pharma A/S Ballerup, Denmark – Remote

CTM_Global Lead/Principal CRA

December 2020 - August 2023

●Proactive CRO oversight

●Review clinical operations/ execution of site monitoring activity ensuring high quality clinical trials meeting ICH-GCP guidelines, LEO Pharma’s global and local SOPs and other national regulations and laws

●Updated best practices to ensure quality research resulting in optimal healthcare outcomes

CTM_Global/ National Lead/ NCTM_Senior CRA

July 2016 - December 2020

●Lead North American/ Global Clinical Trial Management

●SME - CTMS/ eTMF, ICH-GCP guidance & local regulations

●Superuser/Mentor on LEO processes & systems

●Led on-boarding/ refresher training.

●Conducted/ coordinated site management activity (e.g., qualifying, initiating, interim monitoring, close-out)

●Performed Quality Site Visits to assess new CRA(s) site management and confirm site staff performance met standard requirements per feasibility and clinical trial agreements

National Clinical Trial Manager_ Lead CRA/Senior CRA (via InVentiv Health)

March 2016 - July 2016

●Managed North American CRA Team

●Assisted with site budget negotiations & execution per grant plans.

●Study start-up and clinical trials site conduct (initiation/ activation & oversight monitoring)

●Initiated process improvements and QA/QC internal processes for Global Clinical Operations Team.

Advanced Clinical, Deerfield, IL, USA - Remote

Clinical Trial Lead

September 2014 - March 2016

●Engaged in successful bid-defense meetings as CRA team lead

●Accelerated clinical operations management building quality by design during kick off and investigator meetings

●Conduct project-specific training and client meetings (Phase 1 Safety Monitoring Boards, KoMs)

●Conduct demos of CFR Part 11 compliant Business Process Automation System (MAC) to prospective clients

●Develop the Clinical Trial Monitoring Plan (CMP), Study Specific Plan for IP release, ICF Templates, Study Specific Site/ CRA Materials (Investigator Site File, Site Operations/ Pharmacy Manuals, Project Training)

●Create materials (Clinical Monitoring Plan, Blinding Plans, Study Templates/Trackers) to assist with site management, performance of source document verification, review of regulatory documentation, and assessing protocol/ regulatory compliance.

●Mentor/ Train Clinical Research Associates and Clinical Trial Assistants and act as SME

●Review/Prepare reports (e.g., Visit, Follow Up letters, MV trip reports)

Parexel International, Durham, NC, USA – Remote

Senior Clinical Research Associate

October 2013 - September 2014

●Illustrated functional role during external client meetings and presentations such as investigator meetings and bid defenses

●Performed feedback for formal staff review processes.

●Performed on-site visits per monitoring plan with proactive issue resolution

●Recommended appropriate clinical site follow-up responses including potential deficiencies in documentation, communication and the need for additional training

●Identified and evaluated potential data quality issues to determine and implement appropriate follow-up responses including corrective action plans (CAPAs)

Senior Clinical Monitoring Associate

August 2012 - October 2013

●Acted as country level CMA Coordinator

●Mentored project and/ or local team members

●Facilitated internal/external cross functional team meetings

●Represented function in external client meetings and presentations (e.g., bid defense, investigator meetings, etc.)

●Managed remote site visits, staff training, CAPAs, for designated projects

●Defined/Revised and monitored study metrics

ICON (formerly PRA & Research Pharmaceutical Services, Inc.) Fort Washington, PA USA – Remote

Senior Site Manager

April 2010 - August 2012

●Reviewed and annotated Protocol/CRF, developed study manuals, tracking forms, study site tools.

●Conducted site management activities – PSV/ QVs, SIVs/ staff training, MVs, COV/ TVs

●Conducted training/mentoring for SMs, CRAs and CTAs

●Review reports, site communications, follow-up letters of other CRAs

INC Research (formerly Kendle International, Inc.) Thousand Oaks, California, USA - Remote

Clinical Research Associate II

May 2007 - Feb 2010

●Lead CRA responsibilities in order to assist the project team with challenging global rescue study

●Revised CRF guidelines and training presentations ensuring transparency.

●Populated, organized and maintained US project team safety database (IND/ CIOMS reports and corresponding IRB notifications/ acknowledgement letters)

●Managed study site activities to ensure the integrity of clinical data

MedTrials, Inc. Dallas, Texas USA*

Clinical Research Associate I

May 2005 - May 2007

●Lead CRA for first in-human clinical trial conducted upon successful petition from Senator Hilary Clinton to assist patients suffering from chronic gastroparesis

●Supervised a team of 15+ CRA(s) for cardiovascular device trials

●Responsible for project status reports, team metrics, and identifying/ implementing site performance improvements

●Trained/Mentored CRA(s) in the clinical research process, corporate policies and procedures.

Research Assistant (Comparable to In-house CRA)*

Apr 2004 - May 2005

●Served as a liaison between clinical trial sponsor(s) and sites

●Compiled/ tracked project metrics; Reported the status of clinical studies

●Wrote/Revised documents related to clinical research projects (e.g., telephone contact reports, sponsor and investigator correspondence, study file notes, meeting agendas and minutes, etc.)

●Trained/Mentored others in the clinical research process, corporate policies and procedures.

NextPhase Clinical Trials, Inc. Miami, Florida, USA

Clinical Trial Consultant

Jan 2004 - Apr 2004

●Assisted Co-Founder with project management and quality assurance tasks

●Performed business development including site management, human resources, networking with CRO(s)/ Pharmaceutical companies and attending investigator meetings

AFP Clinical Research, Inc. Davie, Florida, USA

Clinical Research Coordinator

Mar 2003 - Dec 2003

●Organized research department for thriving family practice office

●Trained research naive staff including ARNP(s), RA(s), office manager and PI

●Coordinated all aspects of Phase II-IV clinical trials

●Created SOPs ensuring site compliance with GCP/ ICH guidelines as well as state and federal regulations in the conduct of clinical trials research

South Florida Bioavailability Clinic, North Miami, Florida, USA

Study Coordinator

Jan 2000 - Aug 2000

●Coordinated Phase I & II clinical trials for NDA submissions of narcotic/non-narcotic analgesics & contrast agents

●Recruited inpatient & outpatient study participants (9 months - 80+ years)

●Monitored protocol compliance and reported AEs.

●Attended initiation meetings and generated site trial specific source documents

●Performed protocol training of staff

Clinical Therapeutics Corporation, Coral Gables, Florida, USA

Assistant Coordinator

Jun 1994 - Dec 1999

●Provided complete clinical site management and clinical support functions, managed multiple cardiovascular/ endocrinology trials

●Supervised six research assistants

●Wrote/Revised site standard operating policies and procedures

●Developed company safety training programs (OSHA, ICH, GCP)

●Coordinated public relations, developing web sites for networking with site management organizations

Research/Medical/Administrative Assistant

Nov 1992 - May 1994

●Determined patient eligibility, recording/ updating CRFs and regulatory documents

●Performed visit procedures (e.g., vitals, ambulatory blood pressure monitoring, exercise tolerance testing, QOL surveys, pharmacokinetics, drug accountability) and administration.

New Orleans Adolescent Hospital, New Orleans, Louisiana, USA

Human Resources Department Trainee

Jun 1997 - Jun 1998

●Analyzed employee evaluations of mandatory programs for the Staff Training and Development Department

●Compiled employee training compliance, quality assurance & quarterly CEU reports

Tulane Center for Bioenvironmental Research, New Orleans, Louisiana, USA

Research Assistant

Jan 1996 - Aug 1996

●Member of data acquisition team working on a grant to create a water quality database for the Mississippi River

●Performed remote data entry, data management, file transferring and updating utilizing Excel, Word, PowerPoint and FTP

EDUCATION

Tulane University – New Orleans, LA, United States

Bachelor of Science - Psychology, Minor - Microbiology 2004

PROFESSIONAL CERTIFICATIONS

Clinical Research Associate (ACRP)

Sep 2006

Expires: May 2024

Clinical Research Coordinator (ACRP)

Apr 2000

Expires: May 2024

PROFESSIONAL AFFILIATIONS

Association Clinical Research Professionals

Member since: Apr 2000

Drug Information Association

Member: Jan 2006

LANGUAGES

English, Haitian Creole, Basic French & Spanish

PUBLIC PUBLICATIONS & PRESENTATIONS

Salom, Johanna. "Transition Planning: Don't Let Turnover Threaten Your Project."

ACRP 2007 Global Conference and Exhibition, Seattle, WA, USA, 20-24 Apr. 2007.

THERAPEUTIC EXPERIENCE

Cardiovascular

Hypercholesterolemia

Hyperlipidemia

Stable Angina Pectoris

Drug-Drug Interaction

Dose Ranging Study

Prevention Restenosis

Angina

Multiple Dose Safety Study

Hypertension

Systolic Hypertension

CNS Neurology

Transient Insomnia

Migraine Headache

Epilepsy

CNS Psychiatry

Depression

Schizophrenia

Premature Ejaculation

Erectile Dysfunction

Dermatology

Great/ Small Saphenous Vein Insufficiency

Acute Burn injury

Actinic Keratosis

Psoriasis

Atopic Dermatitis

Chronic Hand Eczema

Atopic Hand Eczema

Endocrinology

Type 1 Diabetes Mellitus

Type 2 Diabetes Mellitus

Gastroenterology

Gastric Ulcer

Gastric Motility

Hematology

Deep Vein Thrombosis

Hematological Malignancies

Hepatic Disorders/Liver

Spine MRI Imaging

Immunology

Rheumatoid Arthritis

Graft versus Host disease

Stem Cell, Allogeneic Transplant

Inflammatory Diseases

Crohn's Disease

Knee Osteoarthritis

Gout

Nephrology

End-Stage Renal Disease Anemia

Renal Insufficiency

Oncology

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Advanced Solid Tumor

Synovial Sarcoma

Nut-Midline Carcinoma

Urology

Benign Prostatic Hyperplasia

Lower Urinary Tract Symptoms

Women's Health

Vulvovaginal Candidiasis Infection

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