Regulatory Affairs and Data Management Professional

LUCY LASHER

Olive Branch, MS *******@*****.*** 901-***-****

To capitalize on pre-existing capabilities in a professional setting that allow career development, longevity, and work ethics from conception to completion.

SKILLS

Administrative - Microsoft Office proficiency - Great communication skills - Attention to detail - ONCO EMR

WORK EXPERIENCE

REGULATORY AFFAIRS ASSOCIATE II

West Cancer Center & Research Institute Germantown, TN 06/16 – Present

Works closely with the Sponsor, CRO, Investigator, and appropriate staff across departments, including Project Management, Site Data Services, Contracts, Quality Assurance, and Statisticians. I am running a few minutes late; my previous meeting is running over.

Coordinates the initial submission and ongoing approval of network and/or CRO studies.

Assists the Director of Regulatory Affairs with reports, updating site documents, and meetings as needed. Responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts. Work is performed under the general direction of the Director, Regulatory Affairs.

Collects and maintains all site-specific regulatory documents (Curriculum Vitae for each Investigator, licenses, laboratory certifications, normal lab ranges, delegation of authority information, FDA Form 1572, etc.) Quality control of regulatory documents and processes.

Creates and submits all applicable study documents to the Institutional Review Board, Sponsor, and/or FDA as appropriate. Maintains study binders to include all required documents and correspondence collected throughout the study.

Coordinates and participates in internal and external meetings with project management, site data services, Sponsor/CRO monitoring visits, audits, and other meetings.

DATA MANAGER

Baptist Cancer Center Memphis, TN 10/2013 – 06/2016

Coordinated activities related to sponsor monitoring visits, data collection, investigational drug accountability, and clinical supply monitoring.

Worked with investigators and coordinators (CRC) on case report form (CRF) completion, scheduling monitor visits, and maintaining required clinical supplies.

Worked closely with research staff on various data reports.

Maintained screening logs for sponsors and maintained confidentiality in all interactions with both internal and external contacts.

Maintained data in various EDCs, such as Rave, InForm, Trialmaster, DataTrak, and OnCore.

ADMINISTRATIVE ASSISTANT

West Cancer Center & Research Institute Memphis, TN 12/2012 – 10/2013

Provided administrative support and data manager assistance, maintained shared drive consent folders, protocol binders, filing of original consent forms, screening log for research staff, research patient database, and lab certificates and normal lab values for protocols.

Responsible for ordering supplies, scanning patient documents into EMR, obtaining signatures from investigators, sub-investigators, and nurse practitioners for protocol regulatory documents, distributing protocol amendments and revised consent forms to research staff, and requesting tissue samples from various local laboratories.

MEDICAL ADMINISTRATIVE SPECIALIST

University of Tennessee Health Science Center Memphis, TN 06/2009 – 10/2012

Supervised, advised, and coordinated the work of three administrative assistants in the Department of Pediatrics.

Provided administrative support for the Scientific Director, Administrative Director, Director of Bioinformatics Core, and the Biostatistician of the Children’s Foundation Research Institute, three PhD faculty members, and two MD faculty members in the Department of Pediatrics.

Responsible for correspondence, maintaining schedules, creating PowerPoint presentations, typing manuscripts, coordinating travel, and scheduling meetings.

Coordinated faculty interviews, special events, meetings, departmental seminar schedules, and Administrative Board Meetings with the Children’s Foundation of Memphis and typed and distributed minutes for Board Meetings.

Managed all small grant applications, collected and distributed applications to reviewers, obtained reviews from reviewers, and sent out acceptance or denial letters.

SENIOR ADMINISTRATIVE SERVICES ASSISTANT

University of Tennessee Health Science Center Memphis, TN 08/2000 – 5/2009

Supervised, advised, managed, and coordinated the work of office staff (two secretaries) and approximately 35 faculty/physicians (Critical Care, Endocrinology, Gastrointestinal, General Pediatrics, and Infectious Diseases) in the absence of a supervisor.

Assisted the coordinator in the preparation of M3 clerkship student schedules: clinic schedules, team assignments, notification of all clinics/attending physicians involved, student conference schedules, gathering all pertinent information from Academic Affairs/Oracle.

Prepared and distributed monthly call schedules for Gastrointestinal, Infectious Diseases, and General Pediatrics divisions.

Provided administrative support for the Critical Care Division, General Pediatrics, and Infectious Diseases (12 physicians), which included correspondence, grant preparation, scheduling appointments, creating PowerPoint presentations, managing references via EndNote, typing manuscripts, and handling travel arrangements for out-of-town meetings (travel authorizations, airline reservations, hotel accommodations, meeting registration, reimbursement, etc.).

Worked closely with the Medical Director of Le Bonheur Child Assessment Program (scheduling depositions, court dates, maintaining consults and legal files, and correspondence).

Coordinated activities of Le Bonheur Children’s Medical Center Bereavement Committee. Coordinate Community Pediatrics Schedule for residents.

Scheduled itineraries for faculty candidates in the Department of Pediatrics, Divisions of General Pediatrics and Critical Care, which includes coordinating interview schedules, completing travel authorizations, making airline reservations, arranging hotel accommodations, and reimbursement.

Prepared H1-B visa applications for new faculty in Critical Care, requested copies of journal articles from the library, and troubleshot computer problems for office computers.

Coordinated Critical Care Fellowship Program: developed and maintained accreditation documents for the program, served as primary contact for applicants, and sent and received application packets.

Coordinated applicant interviews, itineraries (travel authorizations and hotel accommodations, notifying and supplying interview documentation to the proper persons involved, and maintained applicant files.

EDUCATION

NURSING PROGRAM

Southwest Tennessee Community College Memphis, TN

BUSINESS CLASSES

Northwest Junior College Southaven, MS

GENERAL CURRICULUM

Delta State University Cleveland, MS

HIGH SCHOOL DIPLOMA

Cleveland High School Cleveland, MS

HONORS

Inducted into Phi Theta Kappa Society, International Scholastic Order of the Two-Year College, Southwest Tennessee Community College, 2004

Thomas C. Lichterman Outstanding Employee of the Year Award, 2000

This award is presented annually to a University of Tennessee Health Science Center or UT Medical Group nonexempt employee who demonstrates the high standards, positive characteristics, and commitment to excellence exemplified by Tommy Lichterman.

Nominated to participate in Secretarial Development Program – completed April 24, 1991

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