Administrative Assistant Clinical Data Pro

Grandella Gipson

*** *** ****** **** *********, NC 27312 • 919-***-**** • ****.******.**@*****.*** Clinical Data Coordinator Skilled professional with more than 25 years of DM experience in the CRO/pharmaceutical industry working in phase I, Ia, Ib, II, III and IV studies as well as Registry studies. Over the course of my career as clinical team lead, data manager and project team member I have supported two published articles and 1 abstract regarding women’s health and breast cancer. I have served on project teams supporting many database locks that have assisted clients with their FDA approvals.

Skills

Detailed oriented • Regulatory Compliance • Team player • Excellent communication skills • Database management, listing review, query resolution and External Vendor reconciliation • Proficient in Microsoft Office/Excel, iMedidata, Medidata Rave, Oracle/EDC • Data analytics Experience

MAR 2025 – present

Office Assistant > Apple Realty of NC, LLC > Durham, North Carolina Answer phone, resolve tenant questions or forward calls to appropriate departments. Greet visitors and assist general public with questions regarding rental properties, scheduling showings and completing applications. Provide coverage for the maintenance department as needed by reviewing work orders for prioritization to vendors, answering calls and returning voicemails. Assist with requests to utility companies for stopping and starting utility service outside of tenant requests. Provide coverage to the leasing office by preparing new leases for review and signatures through Docusign. Assist with new tenants picking up keys by ensuring the renter’s insurance, deposit and utilities confirmations have been submitted. Create file folders for tenants and new owners as needed. Collect and distribute mail as needed. Keep reception area, supply closet, bathrooms and kitchen organized and presentable to the public. Attend bi-weekly team meetings and assist with planning and purchases for larger events as needed.

OCT 2017 – OCT 2023

Clinical Data Coordinator I > ICON Plc > Raleigh, North Carolina Performed routine data cleaning reviews and data reconciliation of clinical and third-party data (our vendors) for subjects enrolled in clinical research protocols based on edit specifications/integrated data review plans. We used a two-fold technique of reviewing data at the page level in iMedidata Rave or by using programmed listings to determine inconsistencies and queried as needed. This was used when the sponsor requested batches of clean subjects be delivered at intervals in conjunction with rolling database locks. Data cleaning in batches was more effective than full study bulk data cleaning nearer to database lock dates. Reviewed system queries that fired from the programmed edit checks in production and closed or re-queried as needed. I issued clear, accurate, concise queries to investigational sites and mentored new team members or new hires to write clear, concise, non-leading queries. Ensured assigned trial tasks/deliverables are achieved in terms of timeliness and quality. Provided constructive study feedback to peers, clinical data scientists, and functional management (daily, weekly, and monthly) when required to meet study deliverable deadlines. SEP 2016 - Oct 2017

Clinical Data Coordinator > ICON Plc > Raleigh, North Carolina Reviewed clinical and third-party data for subjects enrolled in clinical research protocols based on edit specifications/integrated data review plans to facilitate data review. Maintained clinical data management study documentation as appropriate. Participated in sponsor and/or third-party audits. Responsible for identifying trends of an incorrect understanding of protocol requirements or how certain fields needed to be completed on an eCRF. When identified I would then report to the team lead. Updated spreadsheets for internal use with any listings that appeared to not generate correctly and supported workaround efforts until the listing could be reprogrammed. Ensured study and task metrics were tracked and communicated to the clinical data scientist, the project team, and the functional manager. Utilized internal systems to optimize and communicate resourcing issues and needs. Supported data entry activities for local lab normal ranges and identification and documentation of data problems during lab normal range tracking. Documented data issues within the system of record for communication of issues with owners. Addressed data-related questions and recommended potential solutions; escalated issues that could potentially impact study analysis. Managed third-party data reconciliation and the data review process. Provided input into clinical system development activities to identify root causes and systematically resolve data issues. Trained other team members in clinical data management processes for respective protocols. I performed these duties to a high standard of quality under general supervision. MAR 2015 – SEP 2016

Clinical Data Associate III > INC Research > Raleigh, North Carolina Trained/mentored project team members in project-specific requirements. Performed review of discrepancy (edit check) output and validation listings based on test data, issued queries and DCRs based upon this review, and applied self-evident corrections or other global rulings permitted in cases where DCF issue was not required. Attended committee or sponsor meetings, networking with colleagues facilitating new or repeat business. Reviewed database design specifications - including configuration, data structures, and annotated CRF production. Completed all activities of CDA II position as well as performed complex Case Report Forms/electronic Case Report Form (CRF/eCRF) data review with increased independence and efficiency as compared to less experienced data management roles. Performed other work-related duties as assigned to assist the Project Manager with duties (prepare draft eCRF guidelines, create draft DMP). Reviewed and issued draft DCFs raised by the sponsor. FEB 2010 - MAR 2015

Clinical Data Associate II > INC Research > Raleigh, North Carolina Filed study documentation in the Document Control Room (DCR) and eDMSF; completed DMF reviews of binders; created additional dividers, tabs, and sections as needed; notated/flagged sections that are missing versions/signatures or have duplicate and missing pages. Served as subject matter expert for the CD archival process following database lock: created patient profiles and burned to CDs, created CD labels and Acknowledgement of Receipt letters. Packed and shipped CDs via FedEx and created a process for tracking and follow-up of signed/scanned PI signatures of receipt. Attended department meetings, and participated in the internal team, customer, and third-party meetings, taking minutes, as necessary. Reviewed clean subject data for rolling database locks, data cuts, and interim data analysis. Performed discrepancy review and listing review; issues, closes, and resolves site queries. Trained and mentored team members. Remained compliant with SOPs and WIs. Created/managed user access forms for database access; submitted tickets to update or remove study access. Performs SAE reconciliation; reconciles data in the database with external vendors/datasets; resolves issues from QC. Entered test data for EDC screens and edit checks. Performed database lock activities such as final listing review and vendor reconciliation, freezing and hard locking subjects in the database. Entered lab normal ranges and created LNR spreadsheets as needed.

AUG 2009 - JAN 2010

Data Coordinator > Novella Clinical > Raleigh, North Carolina Reviewed clean subject data for rolling database locks, data cuts, and interim data analysis. Reviewed and adhered to the requirements of study-specific Clinical Data Management Plan (DMP) for assigned project(s). Performed discrepancy review and listing review based on data entered in the Case Report Form (CRF) database, upon this review issued queries to sites accordingly. Complied with Standard Operating Procedures (SOPs) and Working Instructions (WIs). Maintained awareness of the pertinent elements of the contract and scope of work for assigned project(s). Maintained proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences. Proactively communicated with the project team lead about resourcing conflicts and availability to take on new assignments. Completed deliverables by prioritizing multiple tasks, adapting to changes in timeline and daily workload. APR 2009 – JUL 2009

Assistant Clinical Data Manager > Quintiles > Morrisville, North Carolina Managed DM customer relationships for the project team including customer negotiations and timelines. Determined resourcing needs and served as a backup for Data Coordinators (DC). Created DMP based on study requirements. Served as Data Team Lead (DTL) on a global oncology study. Complied with SOPs and WIs.

JAN 2005 - Mar 2009

Data Manager II > Duke University Medical Center, Cancer and Leukemia Group B > Durham, North Carolina

Maintained knowledge of assigned protocols, SOPs, and departmental Policies and Procedures. Reviewed and monitored Adverse Events (AEs) and Serious Adverse Events (SAEs). Prepared oral presentations and drafted reports as needed. Served as a resource for various study team members. Consulted with Principal Investigators (PI) and Level III DCs to develop protocols. Presented at Clinical Research Associate (CRA) and Principle Investigator (PI) workshops. Determined participant eligibility status using on-study data. Collected, verified, and reviewed clinical data for accuracy and timeliness of submission. Assisted with the training of Level I DCs. Traveled to and participated in internal and customer team meetings. Participated in the CRF development and review process. Created checklists and spreadsheets to track participant data. Queried sites for data corrections/clarifications or missing forms and made corrections to the database as appropriate. Made amendments to protocol forms; submitted changes to the IT team and form designers. NOV 2002 – JAN 2005

Data Manager I > Duke University Medical Center, Cancer and Leukemia Group B > Durham, North Carolina

Traveled to and participated in internal and customer team meetings. Reviewed and monitored Adverse Events (AEs) and Serious Adverse Events (SAEs). Prepared oral presentations and drafted reports as needed. Collected, verified, and reviewed clinical data for accuracy and timeliness of submission. Maintained knowledge of assigned protocols, SOPs, and departmental Policies and Procedures. Served as a resource for various study team members. Queried for data corrections, clarifications, or missing forms and made corrections to the database appropriately. Participated in committee conference calls. Hosted training sessions while attending both CRA and PI workshops. Created checklists and spreadsheets to track participant data. Determined participant eligibility status using on-study data. APR 2002 – NOV 2002

Data Technician > Duke University Medical Center, Cancer and Leukemia Group B > Durham, North Carolina

Periodically served as a backup to the primary participant registrar. Cross-checked data entered in the database. Provided support to the DCs in preparation for site visits; pulled charts and organized audit data. Updated patient-related study data. Reviewed toxicity forms; replaced IMT codes with MedDRA 5.0 codes. Assisted DCs with various tasks such as creating queries. OCT 2001 - FEB 2002

Clinical Research Associate > PPD > Morrisville, North Carolina Participated in follow-up site initiation phone calls to Principal Investigators (PI), Study Coordinators (SC), and other study personnel. Conducted prequalification calls to prospective sites. Assisted with study file documentation. Reviewed the audit files of the PIs. JAN 1999 - JUL 2001

Social Research Assistant > University of North Carolina at Chapel Hill, Department of Epidemiology > Chapel Hill, North Carolina

Requested and submitted mammographic films from radiology clinics to the Coordinating Center (CC). Developed and maintained tracking systems to monitor study progress and test administration. Served as liaison for cognitive study, communicated with the CC, and administered tests as needed. I was trained to attach the ECG monitoring equipment to participants and provided instructions. Administered standardized neuropsychological instruments and neuro-psychiatric test batteries; tracked and transferred data to the CC. Coordinated all ancillary studies for the Women’s Health Initiative and completed the informed consent process. Trained and oversaw designated staff members in the administration of cognitive assessments and attachment of monitoring equipment, re-certified staff annually. Coordinated participant referrals to the neurologist; provided participant transportation as needed. JAN 1996 – JAN 1999

Processing Assistant III > University of North Carolina at Chapel Hill, Department of Epidemiology

> Chapel Hill, North Carolina

Coordinated clinic and point-of-care appointments and communicated arrivals scheduling changes to clinic staff. Served as backup receptionist (greeted visitors, answered phones, and scanned questionnaires.

Therapeutic Experience

Cardio-Metabolic Hypertension Phase III, Gastroenterology Gastrointestinal Gastroparesis Phase I, Genitourinary Bladder and Overactive Phase II, Genitourinary Women's Health Menopause Phase III, Hematology Blood Anemia Phase II, Hematology Lymphoma B-Cell NHL Phase II, Hematology Lymphoma Chronic Phase II, Hematology Hodgkin Lymphoma Phase III, Hematology Lymphoma Phase I, Hematology Plasma Cell Multiple Dyscrasias, Myeloma Transplant, Stem Cell Phase II, Immunology Autoimmune Lupus (SLE) Phase II, Immunology Autoimmune Psoriasis Phase III, Immunology Autoimmune Rheumatoid Arthritis Phase II, Infectious Diseases Antibacterials Phase II, Neurology Chronic Pain Phase III, Neurology Pain Migraine Phase III, Neurology Post-Operative Pain Phase III, Oncology Solid Tumors, Brain Phase I, Oncology Solid Tumors, Breast III, Oncology Solid Tumors, CNS/Neoplasms Phase I, Oncology Solid Tumors, Prostate Phase III, Psychiatry, Mood Disorders - Major Depressive Disorder (MDD), Respiratory, Asthma - Mod/Severe Phase III, Cardiovascular Risk, Post- menopausal, Genitourinary, Women's Health, Menopause, Female Only; Post-menopausal, Injury and Poisoning, Fractures-Nonvertebral, Female Only; Post-menopausal, Neurology, Dementia, Alzheimer's Disease, Female Only; Post- menopausal Nutrition Support, Female Only; Post-menopausal Education

Bachelor of Arts, Speech Communications > University of North Carolina at Chapel Hill > Chapel Hill, North Carolina

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