Crystal Tarrago, MS
New York City
Summary
Highly-motivated Biomarker Operations Manager with 7+ years of experience supporting clinical research programs across multiple therapeutic areas. Skilled in end-to-end biosample lifestyle management, including collection planning, vendor oersight, sample logistics, biomarker assay development and coordination, and data delivery. Adept at collaborating with cross-functional teams within clinical research, translational medicine and Bioanalytical sciences, as well ass external CROs/Labs.
Overview
8
8
years of professional experience
Work History
Founder
neuro.yogi LLC
New Jersey
01.2025 - Current
- With scientific based evidence, I teach wellness educators the science behind yoga, breath work and meditation.
- I’ve created workshops, resources and materials around the benefits of holistic modalities through the lens of science and collaborate with other groups to build community around wellness and accessibility.
- I lead and co-lead yoga classes, retreats, workshops, women’s circles and wellness gatherings.
- I developed cutting-edge approaches to science for all ages and all people who are interested in learning but struggle to know where to begin. My business is about accessibility to science, wellness and community.
Biosample Operations Manager/ Senior Manager
Schrodinger Therapeutics
New York City
05.2024 - Current
- Built and scaled a biomarker operations function from the ground up successfully hiring and mentoring a small team of experts to integrate into the clinical team
- Leads the development and implementation of the clinical biomarkers and BioA testing plan, sample inventory and tracking, sample logistics and strategies on multiple oncology programs in alignment with the clinical development goals and corporate goals
- Developed processes for internal and external data workflow with CRO’s, lab vendors and internal stakeholders in compliance to GCP/GLP
- Spearheads the biomarker operations processes, logistics, procedures, SOP’s, Clinical Study ICF’s and GCP/GLP requirements to support clinical trials while maintaining sample data integrity
- Manages and executes the biomarker analysis logistics and timelines from sample collection and processing, shipment, testing, Data transfer specifications (DTS) and final sample disposition in accordance with the study protocol, and country specific regulations
- Develops and maintains effective, collaborative relationships with Clinical Study Team, Data management, BioA, CRO’s, vendors and stakeholders
- Manages the clinical biomarker and BioA/PK lab vendors; oversees the vendor selection process (RFI/RFP), contracts, SOW and budgets
- Responsible for generating study related training documents such as lab training slides, and additional training for the study team, sites, and vendors
- Managed daily operations to ensure efficiency and compliance with industry standards.
- Coordinated cross-functional teams to enhance communication and project alignment.
- Delivers relevant strategic plans pertaining to our clinical biomarkers to internal and external stakeholders and leadership
Senior Biosample Operations Specialist
Denali Therapeutics
South San Francisco
06.2021 - 05.2024
- Manage and oversee Biosample collection, processing, and distribution operations for the lifespan of our biomarkers.
- Coordinate with translational sciences, DMPK, clinical pharm, Data management, and Biostats to ensure quality samples and data are executed within timelines for CTT, BTT and TRAP meetings.
- Develop and implement standard operating procedures (SOPs) and policies for Biosample management and processing in Sample Retention, Unblinding and Blinding, ICF Biosample Use
- Builds studies in Labvantage LIMS system from biomarker studies to phase III studies, create LIMS labels and barcodes, and custom Jasper reports and Manifests.
- Monitor and report on Biosample inventory, quality control metrics, and project timelines to both the SET team and development team.
- Participate in the development and review of Biosample-related study protocols, SOA’s, ICF’s, summary’s, IB’s and reports.
- Provide training and guidance to sites on laboratory techniques and procedures.
- Participate in Central Lab and Analytical Lab Selection with Procurements and Clinical Operations in RFP’s, RFI’s, Bid Defenses, study budgets and onsite visits and inspections
Biosample Operation Specialist
Denali Therapeutics
South San Francisco
12.2020 - 06.2021
- Manage and oversee Biosample collection, processing, and distribution operations for the lifespan of our biomarkers.
- Created GCP and HIPPA compliant portal for internal Sample Management team including Tube Standards, Vendor Contacts, Study Budgets.
- Builds studies in Labvantage LIMS system from biomarker studies to phase III studies, create LIMS labels and barcodes, and custom Jasper reports and Manifests.
- Monitor and report on Biosample inventory, quality control metrics, and project timelines to both the SET team and development team.
- Participate in the development and review of Biosample-related study protocols, SOA’s, ICF’s, summary’s, IB’s and reports.
- Build and procure lab materials for clinical studies and send to vendors for absorption testing.
Clinical Research Coordinator & Lab Manager
Boston Center for Memory
Newton
01.2019 - 12.2020
- Managed 13 phase II and phase III clinical trials carrying out all laboratory procedures as well as clinical study procedures while maintaining top 3 global enrollment.
- Arranging all aspects of the trial from study start-up that includes: SIV’s, 1572, FDF, staff training in GCP, IATA, EDC, delegation log, training log, visit source, pre-screening log and obtaining/collecting all regulatory documentation required for study start-up.
- Ensuring GCP when conducting study specific protocol visits, ensuring correct and cohesive visit documentation, data entry, collecting medical history, medication lists / medical records and, collecting and performing lab duties and all pre-screening procedures prior to enrolling a patient.
- Coordinating all visit procedures from travel reimbursements, visit scheduling, data entry, AE/SAE reporting, transportation services, scheduling MRI’s/PET’s, Lumbar Punctures and any other clinical procedure.
- Training and mentoring of new staff members on the tasks required by a research coordinator and lab coordinator.
- Assisting in the hiring process of new staff members as an interviewer, as well as coordinating SIV for new studies, reviewing SOP’s and CAPA’s.
- Managed all study lab procedures including phlebotomy, IV-line placement, EKG, vitals, HR/BP, sample collection within designated timepoints, sample processing per Lab Manual and sample shipment for over 13 phase II/ III clinical trials.
Neuropsychometrician/ Clinical Research Coordinator
Massachusetts General Hospital / Harvard Research
Charlestown
04.2018 - 01.2019
- Cognitive assessments include C-SSRS, MOCA, ADOS-Cog, Trials A & B, Weschler Memory Scales, MMSE, ADL’s, Zahiert Burden, Winterlight, BBBC, Items list etc.
- Prepared and completed study documentation for IRB submissions and protocols.
- Assisted in recruiting patients to participate in the study in both English and Spanish.
- Entered study data/ testing results into internal and external databases.
- Attended weekly conferences on neurodegeneration hosted by the MGH Memory Disorder Unit.
- Managed patient recruitment and informed consent processes for studies.
- Organized data collection and maintained accurate study documentation.
- Assisted in training new staff on trial procedures and policies.
Education
Master of Science - Brain Behavior and Cognitive Neuroscience
University of Barcelona
Barcelona, Spain01.2018
Bachelor of Art - Early Child Development
Lesley University
Camebridge, MA01.2015
Skills
- Biomarker operations
- Biomarker analysis
- Biosample logistics
- Sample inventory management
- Regulatory compliance
- Communication skills
- Mentoring
- Cross-functional teamwork
- Stakeholder engagement
- Data management
- Clinical trial compliance
- Vendor management
- Cross-functional collaboration
- Strategic planning
- Data workflow integration
- Quality control processes
Languages
- English, Native
- Spanish, Level B1
- Italian, Level A1
References
- Sen Zhang, Executive Director of Clinical Biomarker, Sen.zhang@schrodinger.com, +1-857-544-3793
- Dominque Jacquemet-Engelhart, Director of Biomarker Operations, Jaquemet-engelhart@dnli.com, +1-650-575-3233
- Steve Maxwell, Director of BioA/DMPK, +1-201-787-7689
Timeline
Founder
neuro.yogi LLC
01.2025 - Current
Biosample Operations Manager/ Senior Manager
Schrodinger Therapeutics
05.2024 - Current
Senior Biosample Operations Specialist
Denali Therapeutics
06.2021 - 05.2024
Biosample Operation Specialist
Denali Therapeutics
12.2020 - 06.2021
Clinical Research Coordinator & Lab Manager
Boston Center for Memory
01.2019 - 12.2020
Neuropsychometrician/ Clinical Research Coordinator
Massachusetts General Hospital / Harvard Research
04.2018 - 01.2019
Master of Science - Brain Behavior and Cognitive Neuroscience
University of Barcelona
Bachelor of Art - Early Child Development
Lesley University