ALICIA MARGGRAF
Quincy,MA
Summary
Experienced Clinical Research Professional with over 5 years managing regulatory and operational functions of Phase I–III oncology trials. Led cross-functional teams through start-up and closeout phases while ensuring compliance with FDA, ICH-GCP, and institutional standards. Expertise in patient recruitment, regulatory compliance, and data analysis supports successful outcomes in complex research environments.
Overview
15
15
years of professional experience
1
1
Certification
Work History
CLINICAL REGULATORY CONSULTANT
K36 Therapeutics
Cambridge, MA
01.2026 - Current
- Conducted quality control reviews of protocols, informed consent forms, and regulatory materials to ensure compliance and accuracy.
- Identified discrepancies, providing actionable feedback that facilitated compliant revisions and streamlined IRB submissions.
- Supported regulatory readiness and ensured accuracy of participant-facing materials for sponsors.
LEAD CLINICAL RESEARCH ASSOCIATE
Massachusetts General Hospital
Boston, MA
05.2021 - Current
- Lead regulatory and operational planning for multiple Phase I–III oncology clinical trials, ensuring compliant IRB submissions, protocol amendments, continuing reviews, and safety documentation.
- Drive cross‑functional communication with sponsors, investigators, and study teams to align deliverables, timelines, and regulatory expectations.
- Maintain inspection‑ready trial documentation and manage eTMF accuracy and completeness.
- Review informed consent forms and participant‑facing materials to ensure regulatory accuracy and clarity.
- Identify regulatory risks and implement proactive mitigation strategies.
- Support sponsor audits and regulatory inspections, coordinating documentation responses and corrective actions.
- Collaborate with Quality and Compliance to align SOPs and workflows with updated regulations.
- Mentor junior staff and optimize documentation processes to improve submission efficiency.
- Conducted pre-study site evaluations, site initiations, interim monitoring, and study close-out visits to ensure thorough collection of regulatory documentation.
- Coordinated clinical trial activities to maintain compliance with regulatory standards and facilitate smooth study progression.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Supported development of informed consent forms, patient diaries, and study manuals to enhance participant understanding and engagement.
OPHTHALMIC TECHNICIAN MANAGER & MEDICAL SCRIBE MANAGER
VitreoRetinal Consultants
Brookline, MA
08.2017 - 05.2021
- Supervised clinical workflow and staff in a high‑volume ophthalmology practice.
- Documented comprehensive examinations and procedures in Epic EMR.
- Trained and managed clinical staff to improve documentation quality and efficiency.
MEDICAL ASSISTANT
Allergy, Asthma and Sinus of NOVA
Aldie, VA
07.2016 - 06.2017
- Assisted physicians with consultations and diagnostic testing, including spirometry, allergy testing, and immunotherapy.
- Educated patients on asthma, allergies, inhaler use, and EpiPen administration.
- Managed scheduling, insurance verification, and clinical supply ordering.
- Facilitated allergy testing procedures, ensuring patient comfort and accuracy of results.
- Coordinated patient appointment scheduling to enhance workflow and reduce wait times.
- Collected and recorded patient medical histories, contributing to comprehensive patient care.
ASSISTANT MANAGER
The Beach Plum
North Hampton & Portsmouth, NH
03.2011 - 05.2016
- Managed inventory ordering, scheduling, and cash reconciliation to maintain optimal stock levels and operational efficiency.
- Trained and supervised staff across multiple locations to enhance daily operations and customer service.
- Completed all tasks during restaurant opening and closing to ensure smooth operational transitions.
Education
Master of Science - Clinical Research
Massachusetts College of Pharmacy And Health Sciences
01-2025
Bachelor of Science - Biomedical Sciences
University of New Hampshire
01-2016
Skills
- Clinical trial management
- Regulatory submission management
- Regulatory risk management
- FDA & ICH-GCP Compliance
- IRB / Ethics Committee Submissions
- Protocol & Amendment Review
- Safety Reporting & Documentation Oversight
- Inspection readiness
- Site activation
- eTMF management
- IND documentation
- SOP development
- eTMF / EDC Systems / Veeva
- Clinical Data Management
- Vendor management
- Team leadership
- Microsoft Office (Word, Excel, PowerPoint)
Certification
- Good Clinical Practice (GCP)
- Human Subjects Protection (HSP)
- Epic EMR
Timeline
CLINICAL REGULATORY CONSULTANT
K36 Therapeutics
01.2026 - Current
LEAD CLINICAL RESEARCH ASSOCIATE
Massachusetts General Hospital
05.2021 - Current
OPHTHALMIC TECHNICIAN MANAGER & MEDICAL SCRIBE MANAGER
VitreoRetinal Consultants
08.2017 - 05.2021
MEDICAL ASSISTANT
Allergy, Asthma and Sinus of NOVA
07.2016 - 06.2017
ASSISTANT MANAGER
The Beach Plum
03.2011 - 05.2016
Master of Science - Clinical Research
Massachusetts College of Pharmacy And Health Sciences
Bachelor of Science - Biomedical Sciences
University of New Hampshire