Laura Bernal
Kabul
Summary
Dynamic professional with a unique mix of clinical research expertise and a customer-focused background, known for driving efficiency and delivering exceptional service across various industries. Experienced in activating and managing complex clinical drug studies, negotiating contracts, and navigating regulatory requirements with precision. Equally skilled in creating positive, personalized customer experiences, drawing from years of service in fast-paced environments like the spa industry, financial services, and legal offices. Brings an innovative, problem-solving approach to every task, combining a passion for excellence with a genuine commitment to making an impact. I relocated to Kabul, Afghanistan in August 2025 to live with my husband and son, and took time to help my family settle. I am now seeking employment in a humanitarian role in Afghanistan.
Overview
10
10
years of professional experience
Work History
Site specialist and Feasibility Coordinator
ICON (formerly PRA Health)
12.2021 - 08.2025
- Adhere to ICON’s values and industry standards, including ICH/GCP guidelines and applicable country regulations, while assuring timely and accurate communication and documentation of study start-up activities in tracking systems.
- Coordinate the preparation, review and negotiation of Informed Consent Forms (ICF) with study sites, guaranteeing compliance with local requirements and escalating discrepancies to legal and clinical teams for resolution.
- Supervise the execution of Clinical Trial Agreements (CTA), budgets and ancillary agreements, maintaining effective communication with internal teams and study sites while ensuring all approvals are documented.
- Assemble, review and submit regulatory start-up and maintenance packages to ethics committees, institutional review boards and authorities, ensuring all necessary authorizations are obtained within forecasted timelines.
- Oversee preparation, submission and approval of critical document packages (CDP), assuring compliance with ICH/GCP guidelines while facilitating timely communication with sponsors and central review teams.
- Forecast submission and budget negotiation timelines for CTAs, regulatory approvals, and document packages, implementing risk mitigation strategies and contingency plans to address delays and escalating issues as necessary.
Elder Care Consultant / Senior Consultant & Care Coach
Workplace Options
01.2020 - 11.2021
- Rendered expert consultations to families and employees by researching and communicating a wide range of elder care resources, including housing, in-home care, and special needs programs across the nation.
- Refined participant understanding of available senior and disability services by offering comprehensive consultations on Medicare, long-term care, Veteran’s Benefits, and prescription assistance, while addressing specific questions.
- Boosted utilization of community and financial resources for seniors and patients with Alzheimer’s and Cancer by coordinating timely referrals to local service providers and support organizations.
- Surpassed monthly quality and production targets by conducting accurate case research, delivering high-quality consultations, and successfully passing detailed phone call audits.
- Guaranteed participants received prompt and accurate elder care solutions by performing detailed case research and maintaining strict compliance with industry regulations and audit requirements during consultations.
Professional Associate for Club Licensing
Trader Joes
03.2019 - 10.2020
- Improved customer satisfaction by leveraging extensive product knowledge and delivering tailored service via clear communication, attentive listening, and positive language in a fast-paced, high-demand setting.
- Heightened customer retention by resolving inquiries and issues with patience and professionalism, effectively managing high customer volumes and shifting responsibilities throughout each shift.
- Amplified sales and customer loyalty by utilizing deep product expertise to recommend personalized solutions and deliver accurate information that aligned with customer needs and preferences.
- Elevated operational efficiency by quickly adapting to changing tasks and priorities, managing time effectively in a dynamic work environment to maintain smooth service flow.
Financial Associate
Fidelity Investments
02.2016 - 02.2019
- Delivered top-notched client support by managing over 700 inbound calls monthly, addressing retirement savings concerns, and ensuring the highest level of customer satisfaction while providing personalized financial guidance.
- Administered a wide range of 401k plan services, including processing loans, withdrawals, and exchanges, while resolving complex service inquiries and ensuring compliance with IRS regulations and fiduciary laws.
- Leveraged Fidelity Participant Record-keeping System (FPRS) and XTRAC Systems to monitor records and financial structures, assuring seamless integration between front and back-office applications for optimal service delivery.
- Educated clients on 401k plan features, funding options and regulatory requirements, providing comprehensive information on asset management and retirement strategies to enhance client understanding and engagement.
Education
Undergraduate - Communications Public Advocacy & Law, Minor in American History
University of North Carolina
Charlotte, NC05.2010
High School Education - undefined
Sanderson High School
Raleigh, NC05.2006
Skills
- Clinical Research
- Study Activation
- Contract Negotiation
- Regulatory Compliance
- Customer Service
- Remote Work
- Administrative Support
- Document Management
- Budget Forecasting
- Ethics Submissions
- Site Coordination
- Client Relations
- Trial Agreements
- Process Improvement
- Data Entry
CLINICAL TRIAL MANAGEMENT & THERAPEUTIC EXPERTISE
- Therapeutic Experience:
- Hepatology: NASH (Non-Alcoholic Steatohepatitis) - Site Management Associate, 1 Study (Phase IIB), Adult Population
- Internal Medicine: Role in unknown indication - Site Management Associate, 1 Study (Phase Unknown), 1 Month
- Neurology: Myasthenia Gravis - Site Management Associate, 2 Studies (Phase III), Rare Disease, Adult Population, 7 and 9 Months
- Neurology: Epilepsy - Site Management Associate, 1 Study (Phase III), Adult Population, 3 Months
- Oncology (Solid Tumors): Multiple Solid Tumors - Site Management Associate, 3 Studies (Phases I & III), Oncology Subjects, Adult Population, 1 to 10 Months
- Geographic Experience:
- Canada: Neurology, Oncology - Site Management Associate
- United States: Hepatology, Neurology, Oncology, Internal Medicine - Site Management Associate
- Drug Type Experience:
- Biologic: Oncology, Hepatology - Adult Population
- Chemical Entity: Oncology, Neurology - Oncology Subjects, Adults
- Antibody: Neurology - Rare Disease, Adult Population
- System Experience:
- Clinical Trial Management Systems: Medidata CTMS
- Trial Master File Systems: PhlexEview eTMF, Veeva Vault eTMF
Timeline
Site specialist and Feasibility Coordinator
ICON (formerly PRA Health)
12.2021 - 08.2025
Elder Care Consultant / Senior Consultant & Care Coach
Workplace Options
01.2020 - 11.2021
Professional Associate for Club Licensing
Trader Joes
03.2019 - 10.2020
Financial Associate
Fidelity Investments
02.2016 - 02.2019
Undergraduate - Communications Public Advocacy & Law, Minor in American History
University of North Carolina
High School Education - undefined
Sanderson High School