Elaina Seemann
Cleveland
Summary
Dedicated Clinical Research Associate with more than 6 years of experience in clinical research and various clinical environments. Possesses broad background in phase I-III trials across diverse therapeutic areas including oncology, pulmonology, cardiology, ophthalmology, dermatology, nephrology, neurology, and rheumatology. Demonstrates proficiency in site management with comprehensive understanding of ICH-GCP Guidelines. Experienced in both blinded and unblinded monitoring roles with expertise in clinical systems including Veeva, Medidata RAVE, and Calyx IRT.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Associate I
Parexel
08.2024 - Current
- Serves as clinical sites' main point of contact, accountable for quality and delivery from Initiation to Close out.
- Oversees trial conduct ensuring subject protection, data integrity, and compliance with protocols, GCP, and regulatory requirements.
- Builds relationships with investigators and site staff while facilitating access to study systems and ensuring training compliance.
- Addresses site issues including documentation deficiencies and training needs.
- Identifies and evaluates data quality issues, implementing appropriate follow-up actions.
- Performs and reports on-site visits and remote contacts per monitoring plans, including Qualification and Initiation visits.
- Manages test article/study supply accountability, follows up on site payments, CRF data entry, query status, and SAEs.
- Conducts on-site training and facility assessments while maintaining working knowledge of ICH-GCP Guidelines, regulations, and SOPs.
Clinical Operations Assistant I
Parexel
04.2024 - 08.2024
- Completes administrative tasks for Project Clinical Team members across clinical trial phases, contributing to trial efficiency, accuracy, and quality.
- Supports site activation by managing staff access to vendor systems, coordinating required training, and handling Investigator's Site File and equipment shipments.
- Manages Trial Master File with quality, uploading documents timely, updating Expected Document Lists, and resolving Quality Issues. Follows up with site staff and study team regarding pending documents and actions.
- Transfers documents to sponsor TMF systems and supports investigator payment management.
- Addresses site issues, recognizes potential problems, and provides input for contingency plans.
- Collaborates with clinical team on database lock activities and site management closeout procedures.
- Maintains working knowledge of and ensures compliance with ICH-GCP Guidelines, and regulatory requirements.
Clinical Research Coordinator
Associated Retinal Consultants
06.2023 - 03.2024
- Coordinated clinical research studies focused on macular degeneration, diabetic retinopathy, and various other macular and retinal diseases.
- Recruited, assessed eligibility, and enrolled patients for clinical trials per investigator.
- Facilitated study drug administration by PI, monitored for adverse events, and participated in drug accountability.
- Communicated with sponsors, contract research organizations (CROs), and regulatory authorities while assisting with study documentation submissions, audits, and inspections.
Graduate Research Assistant
A.T. Still University
07.2022 - 12.2023
- Conducted literature review to understand the mechanisms underlying vascular stenosis after
angioplasty, and the potential role of nebivolol in reducing recurrence. - Designed and implemented experiments to investigate the effects of nebivolol on bFGF-induced
smooth muscle cell proliferation and migration in vitro. - Cultivated and maintained smooth muscle cell cultures, ensuring optimal cell viability.
- Utilized various assays, including cell viability assays, immunocytochemistry, and trans-well migration
assays.
Ophthalmic Assistant
Northwest Eye Clinic
06.2020 - 06.2022
- Assisted ophthalmologists in patient care, including taking patient histories, and recording vital signs.
- Conducted ophthalmic testing procedures such as visual acuity, tonometry, and visual field testing.
- Provided patient education on eye conditions, medications, and post-operative care instructions in a
clear and compassionate manner. - Assisted with basic administrative tasks, such as verifying insurance coverage, managing patient
billing information, and submitting medical codes.
Education
M.S. - Biomedical Science
A.T. Still University
United States of America01.2024
B.S. - Neuroscience
University of Minnesota - Twin Cities
United States of America01.2021
Skills
- Data Integrity
- Risk Management
- Inspection Readiness
- Attention to detail
- ICH GCP Guidelines
- Start-up experience
- Close-out experience
- Site management
Trial Experience
- Oncology - Breast Cancer, Non-Small Cell Lung Cancer, Papillary Renal Cell Carcinoma, Prostate Cancer, Solid Tumors
- Pulmonology - Asthma, Chronic Obstructive Pulmonary Disease
- Cardiology - Cardiovascular Disease, Pulmonary Hypertension
- Ophthalmology - Autosomal Dominant Optical Atrophy, Diabetic Macular Edema, Refractive Disorder, Retinal Detachment, Thyroid Eye Disease, Uveitis, Wet Age Related Macular Degeneration
- Dermatology - Hidradenitis Suppurativa, Psoriasis
- Genitourinary and Nephrology - Chronic Renal Failure
- Neurology - Rett Syndrome
- Rheumatology - Lupus Erythematosus
Affiliations
Association of Clinical Research Professionals (ACRP)
Certification
Entry Level Knowledge Assessment (ELKA) - ACRP
Languages
English - Fluent
Spanish - Basic
Timeline
Clinical Research Associate I
Parexel
08.2024 - Current
Clinical Operations Assistant I
Parexel
04.2024 - 08.2024
Clinical Research Coordinator
Associated Retinal Consultants
06.2023 - 03.2024
Graduate Research Assistant
A.T. Still University
07.2022 - 12.2023
Ophthalmic Assistant
Northwest Eye Clinic
06.2020 - 06.2022
M.S. - Biomedical Science
A.T. Still University
B.S. - Neuroscience
University of Minnesota - Twin Cities