Summary
Overview
Work History
Education
Skills
Publications
Affiliations
Accomplishments
Work Availability
Interests
Timeline
Nada Saleh

Nada Saleh

North Potomac,MD

Summary

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

19
19
years of professional experience

Work History

Clinical Research Operations and Quality Management support

Axle Informatics
07.2022 - Current
  • Provide technical operational clinical research support to investigators at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) at the National Institutes of Health (NIH)
  • Develop clinical protocols and manage the protocol approval cycle
  • Support the design, planning, scientific review and approval, and implementation of clinical research protocols
  • Spearhead the development of clinical protocols, consent forms, CRFs
  • Prepare manuals of procedure (MOPs) and SOPs that guide the implementation of study procedures
  • Lead recruitment and retention efforts through collaborations with the NIH Patient Recruitment group and digital media vendors outside the NIH
  • Collaborate with data managers and programmers to develop study eCRFs, electronic data capture platforms and databases
  • Monitor research participants’ progress, data collection, adverse events, and protocol deviations or any non-compliance and complete proper follow up and reporting per protocol and regulatory requirements
  • Support the development and implementation of quality management systems to improve quality assurance and protocol and regulatory compliance
  • Prepare IRB submissions for amendments, continuing reviews, reporting of adverse events, and other IRB submission packets
  • Train research team members on protocol implementation, CGP and good documentation practices
  • Maintain clinical research essential documents and keep regulatory binders up to date.

Clinical Trials Specialist

Social and Scientific Systems, A DLH Corp Company
03.2021 - 07.2022
  • Managed the development of phase I and phase II clinical protocols funded by the Division of AIDS at NIAID/NIH.
  • Supported clinical scientists to develop clinical protocols, consent forms, CRFs, study plans and timelines
  • Coordinated efforts across functional groups to resolve issues related to drug supply, budget, and clinical operations
  • Prepared submission packets for scientific review committees and coordinate with protocol teams to address stipulations/comments
  • Prepared amendments, clarification memos and letters of amendment
  • Spearheaded the development of study manuals of procedure (MOPs)
  • Served as a liaison and study point of contact for sites
  • Lead protocol team meetings and site conference calls
  • Prepare meeting agendas/minutes, and track action items
  • Supported day-to-day study execution and track timelines.

Protocol Navigator

Social and Scientific Systems, A DLH Corp Company
07.2018 - 03.2021
  • Managed the development and implementation of clinical protocols for investigators at the National Institute of Nursing Research, NINR/NIH.
  • Developed clinical protocol sections, consent forms, and case report forms (CRFs)
  • Assisted in preparing submission packets for scientific and ethics/IRB reviews; and collaborated with principal investigators to address stipulations/comments
  • Prepared submission packets for amendments, continuing reviews, and ancillary submissions
  • Facilitated the development of patient letters, recruitment materials, and participant retention plans
  • Spearheaded the development of study manuals of procedure (MOPs) and quality management systems
  • Assisted data managers during database development, ensuring systems for collecting, validating, and managing data are in place
  • Assisted investigators in preparation for site initiation visits, study implementation and close-out
  • Coordinated with monitors to facilitate monitoring visits and addressed monitoring findings or escalated them as needed
  • Reported adverse events and protocol deviations per guidelines
  • Managed accurate record-keeping and maintained regulatory binders, ensuring a site is inspection ready
  • Facilitated protocol team meetings
  • Prepared meeting agendas/minutes and tracked action items
  • Supported the development of SOPs and guidelines to standardize processes and promote efficiency.

Research Associate

Evidera Inc.
01.2014 - 01.2015
  • Assisted in the design, development, and implementation of outcomes research studies to assess efficacy and treatment benefit in phase 4 confirmatory trials
  • Provided coordination and technical support for research protocols on testing and validating PRO (Patient-Reported Outcomes) instruments and instrument migration (ePROs)
  • Developed case report forms (CRF), informed consent documents, pre-screening questionnaires, and recruitment materials
  • Prepared IRB submissions, i.e., initial reviews, amendments, and continuing reviews
  • Prepared submission packets for scientific review committees (SRC) review
  • Coordinated recruitment and retention efforts/strategies, identifying target populations and clinical sites
  • Pre-screened participants, scheduled study visits, and administered consent
  • Coordinated with CRAs and project leads during site initiation activities
  • Spearheaded data collection activities and served as a liaison for clinical sites
  • Coordinated with programmers and statisticians to develop study databases
  • Coordinated with site investigators and staff to resolve protocol/data issues and resolve queries
  • Collaborated with CRAs to establish quality management systems that ensure adherence to ICH/GCP and IRB guidelines; thus, minimizing monitoring findings and protocol deviations
  • Coded data and performed analysis
  • Compiled reports.

Associate Outcomes Researcher

ICON PLC
01.2013 - 01.2014
  • Assisted in the design, development, and implementation of outcomes research studies
  • Drafted protocol sections, CRFs, consent forms, patient instruction letters, and recruitment materials
  • Drafted study proposals and budgets
  • Pre-screened participants and obtained and documented consent
  • Prepared structured and semi-structured interview guides
  • Prepared and submitted amendments to IRB
  • Reviewed literature, synthesized information, and presented findings
  • Conducted in-depth telephone and in-person interviews with patients, caregivers, and clinicians
  • Coded qualitative data and performed analysis and interpretation
  • Compiled reports
  • Prepared descriptive and multivariate statistical analysis.

Research Associate

Global Resources Development Consultants
01.2009 - 01.2010
  • Designed and implemented research projects on sustainable development programs sponsored by UNICEF and UNDP Eritrea
  • Reviewed literature and synthesized information; conducted interviews, focus groups, and surveys; and compiled reports and deliverables.

Social Worker

Ministry of Labor and Welfare
01.2005 - 01.2008
  • Supported the management of community-based rehabilitation and integration programs for disabled people
  • Conducted baseline studies on disabled people in various disadvantaged communities, including demographics, socioeconomic status, depression, and other psychosocial problems
  • Supported the monitoring and evaluation of rehabilitation and integration programs and prepared reports to project funders.

Research Assistant

Private Sector Subcontracts
01.2005 - 01.2008
  • Supported multiple research projects through subcontracting to complete tasks such as questionnaire/CRF development, data collection in the field, data analysis, and report writing.

Education

MS - Clinical Research Administration

George Washington University, Washington, DC
2019

MA - Sociology

New Mexico State University, Las Cruces, NM
05.2012

Skills

Ethics and Compliance

ICH Guidelines

Operational Efficiency

Analysis and research

Teamwork and Collaboration

Problem-Solving

Attention to Detail

Organizational Skills

Technical Documentation

Documentation Development

Electronic Data Capture

Data Collection

Site Management

Coordinating site operations

Informed Consent Process

Project management

Adverse event reporting

Patient Safety

Site monitoring

Publications

Understanding the Patient Experience of ALK+ Non–Small Cell Lung Cancer, 2014, JCCN Vol. 12:3

Affiliations

  • Member of the Association of Clinical Research Professional (ACRP)

Accomplishments

  • Supervised team of 5 staff members.
  • Achieved 100% compliance by completing IRB submissions on time and with accuracy and efficiency.

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Interests

Process improvement, regulatory compliance, quality management

Timeline

Clinical Research Operations and Quality Management support - Axle Informatics
07.2022 - Current
Clinical Trials Specialist - Social and Scientific Systems, A DLH Corp Company
03.2021 - 07.2022
Protocol Navigator - Social and Scientific Systems, A DLH Corp Company
07.2018 - 03.2021
Research Associate - Evidera Inc.
01.2014 - 01.2015
Associate Outcomes Researcher - ICON PLC
01.2013 - 01.2014
Research Associate - Global Resources Development Consultants
01.2009 - 01.2010
Social Worker - Ministry of Labor and Welfare
01.2005 - 01.2008
Research Assistant - Private Sector Subcontracts
01.2005 - 01.2008
George Washington University - MS, Clinical Research Administration
New Mexico State University - MA, Sociology

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Nada Saleh