Well versed and detail-oriented individual with a successful track record of showing good clinical administrative support through active listening, problem solving and multi-tasking skills. I would enjoy the opportunity to work within a clinical research organization that performs a variety of clinical research tasks to compile, gather and organize research data for a greater cause.

EXPERIENCE

SEP 2021 – CURRENT

CLINICAL TRIAL ASSISTANT, ICON PLC

RALEIGH, NC

I act as a central contact for the clinical research service team. I perform general administrative duties for Project Managers, Clinical Trial Managers and also assist Clinical Research Associates with time sensitive deliverables. I attend all project team and client team meetings all while taking attendance and the meeting minutes. I assist the clinical team with review of study files within the TMF for completeness and accuracy on a bi-annual basis. I also assist the clinical team with tracking by updating the Clinical Trial Management systems (i.e. ICOTrial, Veeva Vault, BOX, ICOMaster, etc.). I have the ability to work within a system that moves fast and makes changes at the flip of a switch. I work well at adapting to changes.

JAN 2021 – JUL 2021

OPERATIONS SPECIALIST I, IQVIA

DURHAM, NC

I receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. I perform data entry for tracking and Lifecycle Safety databases, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. I help with the preparation of material for submission of secondary review. Assess Lifecycle Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local IQVIA offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting. Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements. At times I mentor less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow. I sometimes provide oversight role to impart technical and process information to the LSM point of contact and members of operational team. I may also provide an oversight role to perform operational and collaborative LSM tasks as directed by Lifecycle Safety Infrastructure. I always participate in team meetings and provide regular feedback to operations team manager and life cycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes. Ensure compliance to IQVIA high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables. Continually participate in training across Lifecycle Safety service offerings. Provide project-specific operational process training to junior team members, monitors and investigative site personnel, as appropriate. I have to liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues. Daily contribution achievement of departmental goals e.g. utilization realization and productivity metrics. I make sure to read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. I ensure all required training is executed in a timely fashion and documented, while working towards ensuring my individual training plan and training transcripts are reconcilable. Perform other duties as assigned.

OCT 2020 – NOV 2020

SAMPLE COLLECTIONS TECHNICIAN, WAKE TOXICOLOGY LAB

DURHAM, NC

This role allowed me to interact with customers daily by collecting each patient’s Real Time RT-PCR COVID 19 (SARS-CoV-2) test sample, contact information, secure billing information and payments for services rendered. My duties included: speaking with customers to ease their fears of the procedure they were to undergo; making sure all paperwork was completed correctly without any missing information; administering the test and packing it properly with the correct paperwork; entering each sample’s details into the database; and generating daily reports for each patient to receive their test results in a timely manner. I also determined the acceptability of specimens for testing according to established criteria, performed routine and complex technical procedures and functions according to departmental Standard Operating Procedures (SOPs), and I demonstrated the ability to make technical decisions regarding testing and problem solving, reported accurate and timely test results in order to deliver quality patient care, performed and documented preventive maintenance and quality control procedures, identified and reordered testing supplies as necessary. I always maintained a safe work environment and wore appropriate personal protective equipment while mostly working independently and sometimes within a team environment when the situation called for it. I remained proficient with computers and was familiar with laboratory information systems and jargon while holding a high level of attention to detail along with strong communication and organizational skills.

MAY 2018 – OCT 2020

HOME HEALTH AIDE

BURLINGTON, NC

This position was a personal choice to take care of my mother who became physically disabled from a fall and began to deteriorate at a rapid pace. So, I made the decision to take a leave of absence from work to move into her home and be a live-in 24 hour nurse’s aide to take care of my mother. She is doing much better now and can move around of her own free will. I can now make the transition back into the workforce to continue my professional career.

JAN 2016 – MAY 2018

SAFETY AGGREGATE REPORT & ANALYTICS COORDINATOR, IQVIA

DURHAM, NC

Former role within the SARA department included supporting the SARA literature services and

individual project teams with sorting mailboxes, completing administrative requests (i.e. submit

GetIT requests, file uploads/downloads; granting application systems access (ELVIS and

DistillerSR), updated literature trackers, etc.), Became a controller in the Oracle ARGUS platform for my department, compiled literature reviews and articles using Google Scholar and other paid subscriptions, scheduled literature projects in the APEX LR/AR/PM tracker(s), scheduled monthly/weekly meetings and attending monthly/weekly meetings for my individual team and department to improve our existing systems and applications. Actual therapeutic areas depended upon which of our 40+ clients we were contractual with, but included: Dermatology, Urology, Gastroenterology, Pulmonology, Cardiology, Obstetrics and Gynecology, Neurology, Radiology, Oncology, Psychiatry and more. Used Trackwise software for complaint management when late in the review process. Uploaded weekly MLM results, gathered team training transcripts for audits, sent out monthly metrics in Excel spreadsheet format to PVS leads and Literature Team and provided administrative support when needed. Worked with international team members in England, Ireland, India and Japan. An integral part in a data integration initiative.

FEB 2015 – JAN 2016

SAFETY ADMINISTRATOR, PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD)

MORRISVILLE, NC

I provided administrative support to the Post-Approval Pharmacovigilance (PVG) department.

Our therapeutic areas included: Cardiovascular, Hematology, Oncology and Gastroenterology. My Responsibilities included: ARISg safety database entry in order to generate reports on AEs and SAEs, quality control, report distribution, usage of MedWatch and CIOMS forms, program file creation and maintenance, and document management. I effectively communicated with project team members, colleagues and client contacts while maintaining company integrity, vision and values. I had a plethora of responsibilities and always managed to meet my deadlines in a timely manner.

AUG 2008 – MAR 2014

DATA ENTRY CLERK II, DUKE UNIVERSITY MEDICAL CENTER

I worked directly with the Administrative Director of Finance and Business Services to verify and

distribute requested financial reports and billing reports, entered clinical data, provided clerical and technical support as required while using Microsoft Office (Outlook, Word, PowerPoint, and Excel). Worked with the implementation team that introduced EPIC to DUMC. I was always able to complete my daily tasks within the given timeframes.

PROFESSIONAL INTERNSHIPS

Clinical Research Coordinator, UNC Liver Program (Fall 2011, 16 weeks)

Enjoyed patient interaction while implementing ICFs, MOPs, and CRFs

Used the Inform EDC successfully to input case data on each Hepatology subject

Assisted in re-developing protocols and updated them for IRB approval

Completed an IRB study renewal form

Completed CITI training and HIPAA regulations review in order to adhere to job requirements

Collected lab specimen samples and added them to a centrifuge in order to be packaged and mailed to an external lab for analysis

Made potential study subject appointments and preparations for established study subjects to get reimbursed for their participation

Clinical Trial Assistant, Triangle Orthopaedic Associates (Spring 2011, 16 weeks)

Learned facility SOPs, Protocol and HIPAA regulations

Completed an IRB study renewal form

Conducted initial phone questionnaires to potential Orthopedic surgery study participants

Understood and implemented inclusion/exclusion criteria for each subject interviewed

Administered feasibility questionnaires to subjects during their 2nd or 3rd visits

Helped explain Informed Consent Forms to study participants

Understood the importance of revenue tracking throughout a study

Entered data from Case Report Forms into the Clindex EDC

Discussed relevant SAEs with team members while inputing data into the ArisG interface

Involved in potential co-workers’ interviewing processes

EDUCATION

MAY 2012

A.A.S. IN CLINICAL TRIAL RESEARCH ASSOCIATE, DURHAM TECHNICAL COMMUNITY COLLEGE

I had a great experience at DTCC. I was challenged and encouraged to think outside the box and

graduated with a 3.2 GPA.

SKILLS

•Multi-tasking

•ICH-GCP Compliant

•Orthopedics (Spinal fusion)

•Study Devices

•Organization

•Cardiology

• Hematology

•EPIC

•Team Player and Communicator

•Hepatology (Liver failure)

•Detail oriented

•Oncology

•Microsoft Office

•ARGUS

•Gastroenterology

•ARISg

•EMA-MLM User

•Trackwise

•InForm EDC User

•Independent worker

•Efficient

ACTIVITIES

I am an avid community outreach volunteer. I work with Justice United (a non-profit organization) to improve the quality of life for individuals in my local area; as far as local jobs being allocated and disseminated equally, fair housing and available transportation. I also love to read, cook and spend time with my loved ones.

Contact this candidate