Clinical Research Coordinator

LAUREN STANTON CCRP, MLS

**** ***** *** **, ***** City, OH 43123 614-***-**** **********@*****.***

EDUCATION AND TRAINING

2020

2018

Master of Legal Studies: Healthcare Law

The University of Oklahoma – Norman Oklahoma

The Society of Clinical Research Associates (SoCRA)

2011

Bachelors of Science: Multidisciplinary Studies (focus on Health Science)

The University of Oklahoma – Norman Oklahoma

CURRENT WORK EXPERIENCE

10/2016 to 12/2019

CLINICAL RESEARCH COORDINATOR

The Ohio State University Medical Center Columbus, Ohio

Identified patients for trials by screening patient medical history in EPIC.

Enrolled subjects for random, open label, and blind trials.

Obtained Informed Consent from patients ensuring understanding of possible benefits, risks, side effects, appointment and treatment obligations.

Dispensed medication and monitored patients through the trial for efficacy, side effects and Serious Adverse Events (SAEs).

Collected and processed all blood/urine specimens for onsite and outsourced evaluations.

Submitted regulatory documentation, correspondence and protocol updates to the Regulatory and Clinical Trials Office.

Collected and recorded patient data and lab results for statistical analysis.

Interacted with multi-disciplinary team to coordinate necessary study evaluations for patients including appointments, radiology, laboratory, outpatient and in-patient services.

Scheduled all follow-up and supportive care for patient discharge referrals.

Provided study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.

Created Standard Operating Procedures for each study or protocol.

Administered/Interpreted psycho-social standardized tests.

Conducted Phase I clinical trial protocols in the department of oncology.

Performed phlebotomy and processing of patient specimens for pharmaco- kinetics, including centrifugation, aliquoting, storage, and shipping to outside facilities per FDA regulations.

Ensured all code of ethics were met for regulatory documentation per GCP guidelines, including case report forms and Investigator Files, collection of data and data transfer, monitoring and reporting SAE's.

Continuously updated skills at conferences to learn and incorporate new practices into daily operations.

Tracking and billing of patients in OnCore

Managed various CNS, GU, and IBD drug trials (phase II, III, IV, open label

compassionate use) including screening appropriate patient placement, enrollment, clinic appointments, obtaining informed consent, collection and recording data for CRFs.

Performed reconciliation of queries from Sponsor and IRB.

Cross referenced site-related essential documents reviewing them for content, consistency with other documents, and compliance with appropriate local regulatory bodies, ICH guidelines, project SOPs and Sponsor requirements.

Reported Adverse/Serious Adverse Events to Sponsor/IRB.

Verified drug accountability logs and storage requirements.

Trials Conducted:

GU Phase I

GU Registry

Alliance

GU Phase II

Abbvie

SWOG

GU Phase III

Tocagen

BeiGene

CNS Investigator Initiated

CNS Multi-site Phase I

IBD Phase II

CNS Phase I

CNS Multi-site Phase II

IBD Phase III

CNS Phase II

Celgene

IBD Registry

CNS Phase III

Janssen

RTOG

NCI

ECOG

RELEVANT WORK EXPERIENCE

11/2011 to 11/2013

2/2008 to 9/2009

TISSUE ARCHIVE ASSISTANT

The Ohio State University Medical Center – Columbus Ohio

Maintain the off-site Surgical Pathology Archive, including organizing, filing, and pulling blocks and slides

Prioritize tasks according to deadlines/workload.

Fulfillment and documentation of specimen requests.

Mail material requests to requesting external institutions

Physical and digital inventory management

Data collection and management from clinical and research sources

Follow HIPAA guidelines to ensure high-level of confidentiality while handling and maintaining records and specimens

Preparation and release of legal requests pertaining to preserved medical device and tissue samples

OFFICE MANAGER

Print Source Graphics – Westerville Ohio

Accounts receivable

Accounts payable

Developed a concise filing system

Developed an inventory-monitoring database

Copy editing

Organize and schedule meetings

Payroll

Manage relationships with vendors and clients

PROFESSIONAL MEMBERSHIPS

The Society of Clinical Research Associates (SoCRA) Current Certification 2018-Present

CONTINUING EDUCATION UNITS

Aromatherapy: Clinical Use of Essential Oils

IBD Horizons Conference

Improving Subject Retention and Data Quality: Studytrax & REDCap

Authorship, Collaborative Research and Peer Review

Beyond Regulations: Ethics in Human Research

RECIST v RANO

OSUMC Phlebotomy certificate

VOLUNTEER WORK

Local Matters Columbus Ohio. From 2014 to present I bought groceries and supported the community in cooking healthy low cost food at home. Additionally planning and using their own garden or a community garden.

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