Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

LaSasha Merrimon

Clinical Research Professional
Nashville,TN

Summary

Resolute and experienced clinical research professional with over 10 years of extensive experience within cross functional teams ranging from Data Management, Quality and Compliance Assurance, Project Management, and Pharmacovigilance across multi-therapeutic areas. Meticulous with history of exceeding company goals utilizing consistent and organized practices. Successfully meets aggressive deadlines and challenges producing quality to best enhance the organizational brand.

Overview

17
17
years of professional experience
7
7
years of post-secondary education

Work History

Coordinator

American Cancer Society, ACS
Nashville, TN
03.2024 - Current
  • Ensures timely and accurate reporting including ensuring data is entered into applicable software and systems (HMS, Salesforce, Marketplace, Concur, ADP, etc.).
  • Assists in the recruitment, training, retention and utilization of volunteers in an appropriate manner to support Hope Lodge program delivery.
  • Serves as a spokesperson for the Hope Lodge and actively promotes community relations and awareness of Hope Lodge activities including tours for civic, community and health care groups.
  • Identifies development opportunities with Hope Lodge guests and community leaders that interact with Hope Lodge; assists with solicitation when appropriate.
  • Reviews and updates patient information, current lodge status, and maintenance logs at the beginning and end of each shift.
  • Improves team productivity with regular communication and progress updates, fostering a collaborative work environment.
  • Manages project timelines for successful completion, ensuring milestones were met and deadlines were adhered to.
  • Collaborates with department heads to develop strategic plans aligning with overall company objectives, fostering a unified approach toward shared goals.
  • Coordinates cross-functional teams, resulting in seamless project execution and enhanced outcomes.
  • Enhances guest satisfaction by responding promptly to inquiries and addressing concerns professionally.
  • Enhances operational workflows by maintaining well-organized documentation systems and updating records accurately as needed.
  • Performs all guest interactions and processes including referrals, screening, check-in, orientation, stay, and check-out in strict adherence to Hope Lodge Operations policies.
  • Ensures safe operation of a Hope Lodge operating 24/7/365 and implements constituent relationship management principles as standard business practice.
  • Partners with area hospitals, clinics and health systems in maintaining guest referrals.
  • Collaborates with ACS staff to ensure financial and volunteer support of the lodge.

CLINICAL SAFETY COORDINATOR

MCKESSON, SARAH CANNON RESEARCH INSTITUTE
Nashville , TN
08.2021 - Current
  • Provides support to Safety Lead for study level activities with Sponsor
  • Proficient in SAE data entry into Argus Safety Database along with providing preliminary assessment for medical coherency of SAE reports
  • Conducts all pharmacovigilance and study level activities according to company SOPs, ICH-GCP, and FDA regulations and guidelines
  • Process incoming serious adverse event (SAE) reports
  • Enters SAE report data, both initial and follow-up reports into SAE tracking data base
  • Performs preliminary assessment for medical coherency of SAE reports
  • Drafts clinical narrative for SAE reports for further review and assessment by Medical Monitor or Sponsor
  • Follows SAE reports until resolution of events
  • Submits necessary SAE report queries to study sites and track for resolution
  • Generates, review, and distributes routine SAE Report
  • Facilitates study level meetings as the Pharmacovigilance/Safety representative
  • Provides guidance and oversight to junior level Safety Specialists
  • Provides guidance on SAE reporting to study site colleagues
  • Performs quality checks in SAE safety database
  • Generates Cover sheets for Pharmacovigilance Safety Department electronic repository
  • Coordinates project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to PM and management
  • Develops and Maintains Contract Modification processes
  • Supports the administrative and financial management of allocated projects
  • Audit preparation and execution at the internal and federal level

CLINICAL PROJECT ASSISTANT

DOCS/ICON PLC
Nashville , TN
06.2020 - 07.2021
  • Provided Clerical Review and assistance in processes in accordance with incoming SOPs
  • Reviewed Serious Adverse Event (SAE) forms, including site follow-up for resolution of data queries, assist in distribution of IND Safety Letters to investigators and tracking of necessary Follow-up Report, as appropriate.
  • Coordinated with clinical project team distribution, retrieval and review of regulatory documents required for initiation of clinical trial
  • Assured currency of required clinical trial documents within Central
  • Filed CVs, FDA 1572s, Lab Certifications, Financial Disclosures, and lab normal ranges, etc. throughout clinical trial
  • Maintenance of project specific regulatory documents inventory systems
  • Prepared investigator grant payment requests and corresponding cover letters for distribution to Sponsor´s Finance and Clinical Investigators
  • Maintained clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites
  • Assisted the Clinical Project Leader/Clinical Research Associate(CRA) in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals
  • Confirmed site receipt of shipped IP, alerts responsible CPL whenever IP inventory requires review/re-order and assists with drug reconciliation
  • Assisted in securing necessary non drug administrative supplies for clinical trials and processes site requests for shipping supplies, as needed
  • Maintenance of clinical trial monitoring and management tracking systems
  • Worked with the US Clinical Project Team to assure successful completion of trials in the US and globally
  • Assisted with CRA/RCRA during routine monitoring visits and follow-up
  • Generated, populated and maintained clinical trial monitoring/management tracking systems
  • Produced project-specific status reports for management

CLINICAL RESEARCH DATA SPECIALIST

VANDERBILT INGRAM CANCER CENTER
Nashville, TN
05.2016 - 06.2020
  • Input, reviewed, and submitted eligibility documentation into data capture systems for portfolio of studies
  • Identified and resolved documentation discrepancies
  • Correctly and efficiently abstracted information from EMR for multiple studies
  • Identified AEs from EMR, provided support to correctly and completely record AEs and serves as resource to CTA II staff
  • Assisted with trending and metrics reports on AEs for each trial and across teams
  • Submitted to sponsor all pertinent data into database accurately and efficiently for Phase I/II/III trials
  • Acted as a preceptor for CTA II staff
  • Reviewed and approved responses to sponsor queries from CTA staff
  • Supported complex queries and works with sponsors on issues; supported initiatives to reduce queries through identification on ongoing issues
  • External Sponsor Monitoring and Visit Management
  • Coordinated monitor scheduling for multiple studies, including fast accruing studies with increased monitoring demand and studies with data locks for FDA submissions and/or national meeting presentations
  • Met with monitors to review data monitoring results, answer questions and resolve queries
  • Demonstrated effective communication with external monitors
  • Monitored study metrics
  • Performed independent reviews of DM deliverables for management staff, PM, and external clients on a regular basis
  • Developed and delivered study specific training for Data Management Project Staff
  • Mentored data team on resolving issues
  • Quality Assurance/Internal Monitoring
  • Queried research team to clarify, reconcile and complete data issues
  • Developed assessment tools to assist clinical staff during patient visits
  • Mentored and trained DM staff to communicate effectively with research team as needed
  • Identified and resolved discrepancies with research team
  • Mentored and assisted data team in effective discrepancy resolution as needed
  • Coordinated data entry, data lock, monitoring and audit deadlines for multiple studies
  • Trained DM staff in good clinical and research practices as it relates to data management as needed
  • Encouraged input as it relates to process improvement
  • Prepared for and participated in clinical trial audits
  • Mentored and trained DM staff to prepare for and participate in internal and external audits as needed

PHARMACY TECHNICIAN

WALGREENS PHARMACY
Nashville, TN
02.2019 - 12.2019
  • Utilized pharmacy systems to obtain patient and drug information and process prescriptions
  • Assisted with and coach's pharmacy technicians in operation of pharmacy systems and cashiers in operation of pharmacy cash registers
  • Developed strong relationships with most valuable customers and patients
  • Performed duties as assigned by Pharmacy Manager and Staff Pharmacist
  • Utilized pharmacy systems to enter patient and drug information, ensuring information is entered correctly, filling prescriptions by retrieving, counting and pouring pharmaceutical drugs, verifying medicine is correct, and checking for possible interactions
  • Assisted in streamlining communication that does not require personal attention of pharmacist, including those to physicians
  • Processed manual claims for third party program prescription services in timely and efficient manner, and performs other clerical duties, as assigned by Pharmacy Manager
  • Assisted and supported Pharmacy Department with inventory management activities

DATA MANAGEMENT SPECIALIST

VANDERBILT INGRAM CANCER CENTER
Nashville, TN
02.2015 - 05.2016
  • Correctly and efficiently abstracted information from electronic medical record (EMR) for multiple studies to include Phase I - Phase 3 clinical trials
  • Input eligibility documentation into data captures system, whether paper or electronic
  • Identified and resolved any documentation discrepancies
  • Identified adverse events from EMR and correctly and completely enter EDC
  • Responded to sponsor queries in timely manner (per SOP or protocol requirement)
  • Scheduled and coordinated all aspects of monitor scheduling for multiple studies
  • Prepared charts and EDC for clinical trial audits
  • Met with monitors to review data monitoring results
  • Exhibited effective communication with external monitors and sponsors

PHARMACY TECHNICIAN

WALGREENS PHARMACY
Nashville, TN
01.2012 - 02.2015
  • Utilized pharmacy systems to obtain patient and drug information and process prescriptions
  • Assisted with and coach's pharmacy technicians in operation of pharmacy systems and cashiers in operation of pharmacy cash registers
  • Developed strong relationships with most valuable customers and patients
  • Performed duties as assigned by Pharmacy Manager, Staff Pharmacist and Store Manager including utilizing pharmacy systems to enter patient and drug information, ensuring information is entered correctly, filling prescriptions by retrieving, counting and pouring pharmaceutical drugs, verifying medicine is correct, and checking for possible interactions
  • Assisted in streamlining communication that do not require personal attention of pharmacist, including those to physicians
  • Processed (corrects and resubmits) manual claims for third party program prescription services in timely and efficient manner, and performs other clerical duties, as assigned by Pharmacy Manager
  • Assisted and supported Pharmacy Department on inventory management activities, such as, ordering, unpacking, checking and storing shipment of pharmaceuticals
  • Maintained knowledge of company asset protection techniques, and files claims for warehouse overages (merchandise received, but not billed), shortages (merchandise billed, but not received), order errors or damaged goods involving Rx drugs
  • Assisted pharmacists with scheduling and maintaining work flow
  • Assisted in preparing for pharmacy audits
  • Worked as part of team to provide support to other members of healthcare team
  • Enhanced pharmacy workflow by assisting pharmacists with medication dispensing, labeling, and packaging.

SALES ASSOCIATE

WALGREENS PHARMACY
Nashville, TN
01.2008 - 01.2012
  • Provided customer service and community outreach
  • Modeled and shared customer care best practices by proactively helping, asking questions to determine customers' needs, and informing customers of options
  • Greeted, listed, and engaged with customers to identify their needs, making them aware of appropriate products and services, and providing warm transfers to other areas of store when necessary
  • Lead and delivered in-store events to promote brand awareness
  • Built relationships with customers; provides authentic closure of customer interaction and built and fostered relationships.

Education

Bachelor of Science - Health Administration

Trevecca Nazarene University
Nashville, TN
02.2023 - 05.2026

HIGH SCHOOL DIPLOMA -

John Overton High School
Nashville, TN
08.2005 - 05.2009

Skills

  • Adherence to SOP's

  • Critical thinking in problem-solving

  • Regulatory Knowledge

  • Comprehensive reporting on metrics

  • Research methodology and data oversight

  • FDA and State Regulations

  • Quality assurance expertise

  • Adaptability and flexibility

  • Relationship building

  • Project coordination

  • Process improvement

  • Workflow management

Accomplishments

  • Excellent Time Management, Organizational and Team Building, Site Relationship building
  • Leadership, Clinical Workflow and Development, Change Management
  • Strategic Planning, Process Design and Implementation, ICH-GCP, FDA Audit experience
  • Quality and Compliance Knowledge/ OSHA Trained
  • Proficient in Windows Excel, Access, One Note, Teams, Outlook Publisher, Word and Adobe
  • EPIC, Starpanel EMR, Oncore, Vestigo, Medidata RAVE, and Inform
  • Report Form Databases (Inform, Rave, Bioclinica, etc.), CTP(Clinical Trial Portal)
  • SharePoint, Veeva Vault, IMPACT, CSAM & Edentity, Argus, MEDRA, and JReview, MedDRA.

Timeline

Coordinator

American Cancer Society, ACS
03.2024 - Current

Bachelor of Science - Health Administration

Trevecca Nazarene University
02.2023 - 05.2026

CLINICAL SAFETY COORDINATOR

MCKESSON, SARAH CANNON RESEARCH INSTITUTE
08.2021 - Current

CLINICAL PROJECT ASSISTANT

DOCS/ICON PLC
06.2020 - 07.2021

PHARMACY TECHNICIAN

WALGREENS PHARMACY
02.2019 - 12.2019

CLINICAL RESEARCH DATA SPECIALIST

VANDERBILT INGRAM CANCER CENTER
05.2016 - 06.2020

DATA MANAGEMENT SPECIALIST

VANDERBILT INGRAM CANCER CENTER
02.2015 - 05.2016

PHARMACY TECHNICIAN

WALGREENS PHARMACY
01.2012 - 02.2015

SALES ASSOCIATE

WALGREENS PHARMACY
01.2008 - 01.2012

HIGH SCHOOL DIPLOMA -

John Overton High School
08.2005 - 05.2009

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LaSasha MerrimonClinical Research Professional