Clinical Research Coordinator and Monitor (CRA) Remote

Trina Lucas Gray Revised **Aug****

TRINA LUCAS GRAY

*** ******** ****

Mount Olive, Alabama 35117

E-mail: adwl6s@r.postjobfree.com

Cell: 205-***-****

CLINICAL RESEARCH EXPERIENCE

IQVIA (SpectraForce/Employment Agency), Clinical Trials Coordinator, 4820 Emperor Blvd, Durham, NC 27703, January 25, 2021 – Current Contractual Position Remote and in Clinic, Parkway Medical Center, 1160 Huffman Rd, Birmingham, AL

Coordinates and organizes activities of multiple components including policies and regulatory procedures. Interacts with appropriate parties to solve protocol problems, obtain updates and renewals; data collection; ensures accuracy of data input; data analysis, generates/prepares reports as required. Coordinate activities of multiple components of clinical trials that will be needed over the course of a trial to ensure that the trials remain on-track. Coordinates the data management activities. Acts as liaison between study team and CRO Sponsor (monitor visits, data discrepancies, etc.). Maintains pertinent records and documentation. Reports adverse events and adhere to Common Terminology Criteria for Adverse Events (CTCAE) guidelines. Follow assigned research participants from recruitment through treatment, discharge, and follow-up. Responsible for collecting, recording, and preparing data for industry sponsored trials. Oversees the delivery of high-quality data from case analysis, data abstraction, and database management from multiple clinical databases. Reviews clinical and external data for subjects enrolled in clinical research protocols based on protocol specifications. SAE/AE/CRF data processing. Answers Queries. Reconciliation of SAE/AE/concomitant medications according to established data management guidelines set by the Sponsor Report study enrollment

(active, follow-up, screen failures). Oversee the scheduling and coordination of all monitoring visits. Pre-Review/Monitor all charts before Monitor Visits to ensure clean data comparing the subjects' source to the EDC. Provide study related information to the monitor and serve as the primary resource during monitoring visits. Ensure data has been entered and monitored for close-out visits. Attending weekly departmental meetings if needed. Participate in regulatory/compliance and educational clinical training as required by institutional policy and department. Serve as back-up for Clinical Research Coordinators during internal meetings by providing patient updates. Perform other duties as assigned. The University of Alabama at Birmingham, Clinical Trials Administrator / Regulatory Monitoring and Submissions, Division of Gastrointestinal Surgery, Department of Surgery, Kracke 629, Birmingham, AL 35294, May 09, 2019 – June 2020 Remote position unless training students and residents were necessary – laid off due to COVID19 cutbacks

Coordinates and organizes activities of multiple components including policies and regulatory procedures. Interacts with appropriate parties to solve protocol problems, obtain updates and renewals; supervises data collection; ensures accuracy of data input; data analysis, generates/prepares reports as required. Coordinate activities of multiple components of clinical trials that will be needed over the course of a trial to ensure that the trials remain on-track. Acts as liaison between study team and CRO Sponsor (monitor visits, data discrepancies, etc.). Maintains pertinent records and documentation. Locate ICD-9 codes for adverse events and adhere to Common Terminology Criteria for Adverse Events (CTCAE) guidelines. Follow assigned research participants from recruitment through treatment, discharge, and follow-up. Responsible for collecting, recording, and preparing data for industry sponsored trials. Oversees the delivery of high-quality data from case analysis, data abstraction, and database management from multiple clinical databases. Reviews clinical and external data for subjects enrolled in clinical research protocols based on protocol specifications. SAE/AE/CRF data processing. Reconciliation of SAE/AE/concomitant medications according to established data management guidelines set by the Sponsor Report study enrollment (active, follow-up, screen failures). Trina Lucas Gray Revised 19Aug2022

Oversee the scheduling and coordination of all monitoring visits. Provide study related information to the monitor and serve as the primary resource during monitoring visits. Ensure data has been entered and monitored for close-out visits. Set-up close-outs visit for Pharmacy and Principal Investigator. Attending weekly departmental meetings. Participate in regulatory/compliance and educational clinical training as required by institutional policy and department. Serve as back-up for Clinical Research Coordinators during internal meetings by providing patient updates. IRB submissions, start-up and renewals. Perform other duties as assigned.

The University of Alabama at Birmingham, Clinical Research Trials Associate / Clinical Trials Monitor, Comprehensive Cancer Center, Clinical Trial Network and Monitoring Office, 1802 6th Avenue South, NP 2523, Birmingham, AL 35294, June 14, 2010 – May 08, 2018 Accounting: Tracking invoicing regarding site payment per study once case report forms, queries, and monitoring are complete per study, works with sponsors and grant / contract administrators to complete negotiation of clinical trials agreements, etc. Assisting the administrator over the TBCRC accounts and invoices / budgeting process. Working closely with CRU regarding the preparation, billing, invoicing, and reconciling accounts per budget. Traveling to meet with the TBCRC to discuss building and designing a better way of handling subcontracts, budgets, and invoicing. Data Entry / Regulatory: Created an in-house system in tracking each site’s regulatory including approvals, renewals, amendments, 1572’s, financial disclosures, CV’s, medical licensure, lab ranges, CLIA, CAP, OnCore Data Management regarding entering regulatory documentation to share with CRU, entering all IRB submissions per site regarding, start-up, amendments, 1572, renewals, etc., querying sites for expired regulatory information, etc. Clinical / Research Specific: Knowledge of screening and randomizing subjects per study/protocol, knowledge of each protocol to assist with monitoring and placing subjects on study, familiar with AE and SAE reporting, reporting / meeting / conference calls for each study / protocol based on breast or lung studies, answering questions when the actual clinical monitor is out of the office regarding information per study, coordinates and performs a variety of research and administrative activities required in the management of clinical trials research, duties include assisting principal investigators and / or other members of the research team in the development of protocols, budgets, and plans for clinical research studies; coordinating the preparation and submission of reports, documents, and correspondence for regulatory agencies and internal review board; interpreting and applying regulatory and policy requirements to protocols and procedures, helps to ensure adherence to Food and Drug Administration (FDA) and protocol guidelines, identifies potential problems and / or inconsistencies and informs supervisors as needed. The University of Alabama at Birmingham, Office Service Specialist III / Clinical Trials Coordinator, Division of Pediatric Nephrology and Transplantation Research, 1600 7th Avenue South, ACC 516, Birmingham, AL 35233-1711, Nov. 27, 2007 – June 13, 2010 Accounting: Working with accounts payable and receivable, purchase orders, travel requisitions, liaison with UAB Accounts Receivable, Payable and Purchasing Department, maintain a filing system and data entry system to track accounts in-house accounts, ordering supplies, paying bills by internal requisition or by using UAB Oracle, maintain financial binders for all studies, etc. Clerical: Typing, phones, maintain computer and other equipment services, copying, faxing, tracking payments, creating source documents, errands, maintain conference call and meeting scheduling and calendars, creating data banks and Excel spreadsheets, confirming updated CV’s and medical licensure, answer billing questions, errands, ordering charts from medical records, brochure, and flyer layouts in Publisher, etc. Medical: Maintaining patients’ privacy under HIPAA standards, assisting nurses with lab related duties

(spinning blood / centrifuge), witnessing consents, maintaining IATA standards when shipping biohazard materials, assisting in clinic day of study, picking up labs and entering results into Logician for the physician to review, etc.

Trina Lucas Gray Revised 19Aug2022

The University of Alabama at Birmingham, Data Processing Specialist, Division of Infectious Diseases Research, NIAID Mycoses Study Group (BAMSG), Birmingham, AL, 1999 – 2002 Clerical / Data: Improving detailed data entry utilizing Access data banks and Excel spread sheet information daily. Maintaining: MSG / BAMSG Participant Directory, Cumulative Abstracts and Publications Directory, multi-center site information (99 sites) (enrollment log, SAE logs, CRF tracing, site personnel, contact information, etc.), NIH and IRB central filing for the MSG / BAMSG, etc. Accounting: Working with accounts payable and receivable, online check request (TPX, FAS tracking), disbursement requisitions, purchase orders, travel requisition, etc., liaison with UAB Accounts Receivable and Payable Department and Purchasing Department, maintain a filing system and data entry system to track accounts in-house, liaison with UAB Travel (payments and all travel arrangements), etc. Miscellaneous Office Duties: Typing, formatting, mass faxing, mass mail-merges, Fed Ex disbursement and tracking, phones, maintain computer services, fax and copier services, ordering office supplies, problem solving, scheduling catering, assist in the planning and organization of the MSG / BAMSG Annual Meeting in Bethesda, Maryland (reservations, expense accounting, actual attendance, printing, room coordination, etc.), scheduling conference calls, assisted in the renewal of the BAMSG contract, mass copying, office filing, etc. The University of Alabama at Birmingham, Office Services Specialist, (Department closed), Options, Services for Adult Students, Special Studies, Credit Courses, Birmingham, AL, 1995 – 1999 Created and maintained Access and Word data banks used in student tracking, mass marketing mail- outs, brochure layouts, tracked marketing information, formatting, typing, light accounting, mass Word merges, assisted in transferring the department from Special Studies to Options, mass faxing, copying, phones, customer service, assisted in office management, etc. EDUCATION

Mortimer Jordan High School, Morris Alabama

Standard High School Diploma, Music, Business, Art, 1989 PROFESSIONAL MEMBERSHIPS/CERTIFICATIONS:

Credit and Non-Credit Courses

UAB Research Coordinator Training

Oracle Training

RedCap Training

CT.Gov Training

IRAP Training

IMPACT Training

OnCore Training

VA at Birmingham and UAB CITI

EDC

WOC Birmingham VA

Attending Current SOCRA CEU’s

ICH-GCP

CITI

Study Hub

Study Group

Medidata RAVE

Etc.

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