Nicole Anderson

Raleigh, NC

adwmcc@r.postjobfree.com• 910-***-****

Clinical/Medical Research Analyst

Experienced clinician facilitating in strategic and operational coordination and planning that have shown demonstrated success and growth. Possess strong organizational skills with the ability to multi-task, prioritize daily tasks, and perform successfully in a fast-paced environment. Excellent time management, organizational and self-planning skills displaying flexibility by adjusting work schedules according to changing priorities, meeting demanding deadlines and producing high quality work. Ability to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situations, and tight deadlines. Ability to make commitments, track and communicate progress, and follow through until completion. Proficient with Microsoft Outlook, Word, Excel and PowerPoint and internet. Strong oral and written communication skills, excellent organization skills with the ability to prioritize tasks. Knowledge of International Conference on Harmonisation – Good Clinical Practice (ICH-GCP).

•Data Management

•Data Analytics

•eTMF Filing

•Rave EDC

•ODQA Reports

•Minute Taking

•Research

•Auditing

•iSite

•Operational Metrics Reports

•Tracker Creator

•Record Maintenance

•Quality Assurance

•Firecrest

•ORACLE Reports

Career Experience

ICON

Clinical Trials Assistant, Jun/2022 to Present

As the CTA, I support the PM, CTM, and other study team members, internal and external, with daily administrative tasks and duties directly related to the conduct of the clinical study according to Good Clinical Practice (GCP). Schedule meetings and preparations for daily, weekly, and monthly meetings, agenda and secretary of meetings including preparing the meeting minutes. Track updates and distribution of products, clinical and laboratory supplies. Perform system updates and data entry for clinical studies, filing documents and maintaining documentation throughout the study period. Create trackers for team members and CTM and PM. Create access to study for team and site members, filing payment codes for sites and vendors, communication, and correspondence with study team members on the updates and outcomes of clinical study trials. Coordinate the filing of Trial Master File (TMF) documents in the electronic Trial Master File (TMF) part of ECO by reviewing completeness and correct use of ECO. Perform email blasts, bulk mailing newsletters, scanning and uploading documents after every trial period, and other tasks as appropriate. Assist with signature collection of Confidentiality Disclosure Agreements, Purchase Orders, and insurance certificates in collaboration with CTM/Vendor Management.

Lexitas Pharma Services, Inc.

Clinical Trial Assistant, Jan/2023 to Apr/2023

As a CTA, I set-up Clinical Operations’ paper or electronic folders, as applicable Process Clinical Operations’ administered TMF records: scan, index, quality check and file against pre-defined quality criteria and in compliance with service levels.

Manage TMF inventory trackers or eTMF reports. Support TMF/eTMF review process by working closely with study teams.

Prepare for receipt of CRO’s portion of the TMF/eTMF Process the CRO’s portion of the TMF/eTMF in a timely and controlled manner in accordance with procedures . Assists study team in collection and tracking of essential documents, IRB submissions, procurement and shipment of supplies to sites. Assists with review of both internal and external documents, including essential documents and IRB applications. Assists with development of data management-related study documentation (Data Management Plan, eCRF completion guidelines, edit check specifications, data management report specifications, project specific training, EDC testing). Participates in EDC user acceptance testing and/or validation activities. Perform routine data cleaning tasks including query issuance, review, resolution, and manual listing review. Maintain current metrics on data management activities and provide ongoing updates to Clinical Data Lead. Support database closeout activities including reporting and data archiving. Performs other tasks as directed by line management or project leadership.

LIGHTHOUSE LAB SERVICES/ELITE DIAGNOSTIC

Clinical Laboratory Toxicologist, Nov/2020 to Aug/2022

Work in the laboratory of Rapha Healthcare operating screening analysis and LCMS independently. Provides medical laboratory toxicology testing on the Mindray screening analyzer, Biolis analyzer, Absciex and LCMS Agilent analyzer. Performed specimen accessioning and manual extraction of urine patient samples including aliquoting, centrifuge, pipetting, plating on 96-well plate, and testing. Conducted daily Quality Control, Weekly Calibrations, Preparing Reagents and Mobile phases, cleaning LC/MS source, fine tuning, and updating daily Temperature and maintenance logs. Implemented analytical procedures; evaluating laboratory information; reporting results according to protocols mandated by CLIA, Medicare, Medicaid, and public health department.

Maintained medical laboratory equipment performance by performing quality standards; following daily operations, quality, and troubleshooting procedures; ensuring CLIA compliance and regulations; certifying instrument performance; arranging equipment replacement, service, and repair receipt of supplies. Maintained quality results by following quality assurance procedures; consulting with Laboratory Director and Quality Assurance team; performing proficiency and CAP surveys; Maintains medical laboratory supplies inventory by checking stock to determine inventory level; placing and expediting orders for supplies; generating reports; maintaining records. Maintained medical laboratory information system by identifying information needs and problems; recommending improvements; establishing priorities; testing; writing user manuals; maintaining security and confidentiality.

Maintained professional and technical knowledge by completing continuing education, reviewing professional publications.

Provided administrative support for the clinic as the independent technologist/data reviewer on site. Performed certification review of LC/MS data utilizing Analyst and Masshunter software including verification of quality controls and calibrations.

LABORP, DURHAM, NC

Clinical/Medical Laboratory Technologist, Dec/2014 to Nov/2020

Render expertise in performing confirmatory testing on client samples, Quality control samples, NRC, and proficiency samples, and resolving quality trouble shoot as well as maintaining lab equipment. Perform complex chemical extractions on donor urine for liquid chromatography tandem mass spectrometry (LC-MS/MS). Operate LC-MS/MS instrument and perform routine maintenance. Operate Tecan and Hamilton automated pipetting systems for testing of donor and maintenance of instruments. Operate GC/MS instrument and perform routine maintenance on GC/MS instruments, run analysis on donor urine and ensure forensic acceptability of data. Update sample information in LIMS. Document all specimen test procedures with accuracy, consistency, and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines, including, updating SOPs, and assisting with troubleshooting. Maintain laboratory records, maintenance logs, quality control charts, and reagent and standard logs. Order weekly lab supplies for GC/MS and LC/MS laboratories. Serve as a member of the Quality Assurance Committee prepare labs for audits from CAP, DOT, NLCP, NRC Audit, SAMHSA Data Audit and perform internal audits in GC/MS, LC/MS laboratories. Assisted in process improvements to increase data quality, lower costs, or reduce turnaround times

LANES FUNERAL HOME, KINSTON, NC

Assistant Director/Assistant Embalmer, Apr/2004 to Nov/2006

Preserved human remains to prevent deterioration and infection. Reconstructed damaged parts and applied cosmetics to improve appearance. Involved in order embalming supplies, including chemicals and bandages. Collaborate with funeral arrangers to ensure families’ wishes are met and fill any legal paperwork. Conformed to laws of health and sanitation, OSHA and ensure that legal requirements concerning embalming are met. Used knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography, and transcription, designing forms, and other office procedures and terminology.

Therapeutic Areas of Experience

• Cancer (Gynecological Malignancies and High-Risk Metastatic Castration-Resistant Prostate Cancer, Cancer, Solid Tumor, non-specific)

o Phase I, II

• Ophthalmology (SUPRACHOROIDALLY ADMINISTERED CLS-AX IN PARTICIPANTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION)

o Phase IIB

Educational Background

Bachelor of Science / Forensic Biology

Guilford College, GREENSBORO, NC (Aug/2014)

Bachelor of Arts / Mortuary Science

Fayetteville Tech, FAYETTEVILLE, NC (Sep/2007)

Bachelor of Science / Business Administration

Fayetteville State University, FAYETTEVILLE, NC (May/2002)

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