Andrea Gdonski Email & Phone Number

Morrisville, Nc, Us

Responsible for the coordination, execution, and monitoring of all activities related to the capture, transfer, and storage of external vendor electronic data. Provide technical oversight of non-CRF data acquisition related activities including multiple data providers and Clinical Research Organizations (CRO). Ensure data standards are implemented into file specifications and data mapping and oversee adherence by CROs and data providers. Leads all aspects of projects including managing timelines and interfacing with stakeholders. Virtually lead and work with team members for training and mentoring providing constructive, positive solutions.>> Applies project management methodology to ensure the timely and accurate completion of all activities across workstreams with varying priorities and timelines.>> Proactively drives quality of deliverables as well as ensures timelines and milestones are met.>> Provides technical oversight of non-CRF data acquisition related activities through communication with multiple data providers and Clinical Research Organizations (CRO). >> Assists in coordinating and overseeing all non-CRF data, applications, training, and performance of CROs across non-CRF data acquisition process. >> Builds and fosters relationships with all stakeholders ensuring effective communication is maintained and project status reports are provided.>> Facilitates resolution of project related conflicts with necessary corrective action and alerts stakeholders to potential issues.>> Continually reviews and makes recommendations to ensure adequate resources are available to meet project deliverables and milestones.>> Works with internal and external teams in drafting and finalizing data transfer specifications for Non-CRF data to be sure the data is received as required by the study teams in a quick & timely manner.>> Works on over 20+ studies on a daily basis from trouble-shooting to maintenance.

Morrisville, Nc, Us

Ensures the successful and accurate transfer of clinical trial data from laboratories and other clinical dataproviders to a Clinical Data Management System (CDMS) or other data repository. >> Receives electronic data files containing clinical trial data from external data provider and conducts data preparation steps to ensure the data is ready for processing. Loads processed data into CDMS or other data repository.>> Troubleshoots data load and processing errors and liaises with study teams and data providers to resolve issues. >> Serves as the point of contact for electronic data inquiries from data providers and study teams.>> Acts as primary point of contact for study teams and clinical data providers as it relates to the acquisition and processing of external clinical trial data.>> Liaises with study teams and clinical data providers to establish and communicate data standards and file format requirements.>> Processes electronic clinical trial data files and loads data into the CDMS (eg – Oracle Clinical, Medidata, Rave) or applicable data repository.>> Works with all team members to assist in questions, guidance and collaborate on creating "HOW TO" documentation for ease of working the internal processes.>> Develops the study specific Pharmacokinetic (PK) definition file template according to the study specification and sends the PK definition file template to the central lab after performing the required quality control checks.>> Reviews study protocols and provides data transfer specifications to study teams and vendors (internal and external) for the safe receipt of Non-CRF data.

Sellersville, Pa, Us

>> Greeting patients, verifying insurance details and scheduling appointments as necessary. Working as a liaison between the physician and patient. Updating and working in multiple systems on a daily basis: Meditech, CONVERGE and EMR Scanning. >> Placing outgoing calls as necessary for required paperwork that may be required to provide a GRAND experience to the patient. >> Administrative & clerical duties demonstrating the necessary skills to perform all patient related duties to ensure the quality care to the adult and geriatric patient. >> Demonstrating problem solving skills along with strong verbal, communication and listening skills. Interpersonal skills between internal and external employees (doctors, nurses & technicians) and patients. >> Ability to maintain the strictest levels of confidentiality

Us

>> Worked together with agents, underwriting staff and members to maintain document compliance and accuracy using extensive knowledge of processing procedures, guidelines and team concepts.>> Exceeded departmental benchmark for average handle time of three minutes, processing tasks in 1-2 minutes, as well as a 90-93% average monthly production efficiency ranking in the top 10 out of 4 departments.>> Delivered timely solutions for members, agents, underwriters and partners on a consistent basis by providing exceptional customer support. >> Communicated with executives about issues and provided feedback to resolve and work towards a better outcome.

Dublin, Ie

>> Played a vital role working collaboratively with internal teams & external clients to collect and verify clinical data, managing medical accounts in Electronic Data Capture (EDC) systems and clinical trials across multiple platforms (Medidata, InForm, RAVE, DataTrak, ORACLE).>> Maintained compliance with FDA standards through the timely and accurate filing of all standard operating procedures (SOPs) and study specific procedures (SSPs).>> Exceeded departmental metrics by 200% in addressing over 80-90 e-Mail inquiries per day.>> Actively worked to provide quality of data collection for over 80 studies simultaneously from study-start up and through study lock.>> Generated study file PDR's and PDF's providing labels, CD's and letters for sites as required.>> Created and maintained study files and other appropriate study documentation on a daily basis.

Dublin, Ie

>> Reviewed and resolved data entry issues using double data entry quality control method. >> Effectively performed database and UAT (User Acceptance Testing) fully documenting all issues in accordance with relevant procedures.>> Entered patient clinical history with speed and accuracy and exceeded standards established by the department.>> Trained colleagues on new procedures & study set up details. >> Point person leading the team for a million dollar awarded trial working closely with other team members, management and client to trouble-shoot when system issues arose.

Dublin, Ie

>> Tracked clinical data for research studies.>> Entered clinical data according to company SOPs. >> Performed manual and electronic audits on clinical data.>> Filed and archived study data and documentation.

Dublin, Ie

>> Completed double data entry and verification in accordance with SOPs. >> Reviewed and resolved discrepancies between first and second pass entry of clinical data. >> Executed query updates and/or verification based on resolved data query form in accordance with relevant SSPs.>> Performed quality reviews / audits on clinical data and documented issues raised.>> Database and UAT (User Acceptance Testing) performed of data entry screens and forms.

Carrollton, Texas, Us

>> Held multiple positions over my tenure with the company starting in the mailroom and working my way up and finishing as a Senior Customer Service representative. >> As a Senior Customer Service representative I assisted with performance reviews of a 6- person customer service team in a call center atmosphere.>> Responded to 80+ phone calls daily from distributors and internal team members, processed returns, debits / credits and all other duties on a daily basis.

Coursework, Accounting And Business Administration

High School Diploma, General Studies