Clinical Research Data Entry
Resume:
TRACY LAWRENCE
CONTACT
******************@*****.***
Thomasville, Ga 31792
SKILLS
EDC: Oracle, InForm, Medidata Rave, Veeva, Study team, Greenphire,
Microsoft word, excel, PowerPoint, Internet Explorer, and Microsoft
CRIO, SIP, Study docs, Clinical Trial system (Lilly)
Patient Record Database Management
Drug Storage Procedures
Lab Specimens and Collections
Regulatory Requirements
Specimen Storage
Site Management
PROFESSIONAL SUMMARY
Ready to make an immediate contribution to your organization. Hardworking, highly motivated professional eager to lend combined knowledge and skills to enhance business performance. Operates well in individual and team capacities, leveraging seasoned work ethic to quickly adapt to different processes and drive company objectives. Resourceful and results-driven with a passion for growth and efficiency to meet company needs and increase service value.
EXPERIENCE
May 2022 - August 2023
Clinical Research Manager/ Travel Lead Clinical Research Coordinator
Care Access, Boston, MA
Responsible for regulatory tasks: Start-up activities for study participation, complete intake form, budget checklist, PI, and Study Coordinator efforts.
Provides oversight to the clinical research coordinators including going to sites as required.
Manage all study training materials, ensure that they are updated and managed within the company's document control system; ensure all team members are up to date and ready for each deployment.
Review all invoices for CRCs, find discrepancies, and approve contract employees.
Deployment of CRCs after receiving assignments from the Program Manager.
Maintain the work schedule of team members.
Assist Clinical Research Coordinators on deployments with daily Sync meetings to address any immediate issues.
Responsible for ensuring the team accurately executes the QC of charts and retrains as needed.
Actively work with the QC team to ensure accuracy and quick turnaround of data entry into EDC.
Ensures completion of source documents and assesses accuracy and completeness by reviewing QA reviews completed.
Drive patient recruitment with a data-driven approach by assisting the team with recruitment needs at each site.
Ensure the DOA log is accurate and updated as necessary for each site.
Ensures compliance with Clinical Trial Management System (CTMS), TMF(Trial Master File}Electronic Data Capture, and other key systems in assigned studies. Data entry, Data Management, Analytical skills, Interpersonal skills, and Policies and Procedures. Conducted patient visits, collected samples, blood draws, lab packing, and administered treatments according to the protocol.
Escalates, as needed, different challenges and issues to the Senior Manager/Associate Director, and Program Manager. Team Lead.
Assists with hiring and training of CRCs.
FDA Inspection Readiness.
Perform other duties as assigned
Opening new sites ensures the sites have everything to start the study.
July 2019 - May 2022
Lead Travel Clinical Research Coordinator
Care Access, Boston, MA
Discussed research study with potential research participants and consenting patients. Provide support activities on multiple clinical research studies.
Reviewed adverse event reports submitted by sites to determine if they meet the criteria for reporting to regulatory agencies. Work closely with clients to ensure data required for study start-up is collected and maintained.
. Prepare and modify various documents and reports using Microsoft Office.
Maintained accurate records of all trial activities ensuring timely completion of essential documentation and EDC. Ability to work with multiple deadlines in a fast-paced and ever-changing environment.
Conducted patient visits, collected samples, blood draws, lab packing, and administered treatments according to the protocol. Adverse Events, Severe Adverse Events, vitals, administering questionnaires and dairies, Height and weight, medical history, progress notes, Communication with PI, and Monitors.
June 2006 - June 2019
CLINICAL RESEARCH COORDINATOR
Atlanta Diabetes Associates, Atlanta, Ga.
Present: Serve as the primary contact to ensure appropriate communications, trial management, and coordination of the operational aspects of a new and ongoing clinical trial at the site. Critical thinking, Customer service Capacity.
Working under the supervision of the Principal Investigator(s), while exercising excellent clinical judgment in patient monitoring and care.
Responsibility for executing the protocol and ensuring that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained on the protocol. Conduct Phase I-IV. Conducted over 50 studies Handled .8-40 patients.
Patient recruitment and pre-screening, vitals and blood draw, lab processing and preparing labs, EKG, EDC, and study devices.
Investigator, such as informed consent documents, case report forms, enrollment logs, and drug/device accountability logs.
June 2006 - June 2019
TRAVELING CLINICAL RESEARCH COORDINATOR
Clinforce Inc, Durham, NC
Conduct ICF process per site SOPs, GCP, Sponsor, and applicable regulatory requirements.
Collect vitals and perform phlebotomy and blood draws and lab packing as required per protocol.
Complete data entry and address any queries/discrepancies as appropriate utilizing various EDC systems, per Sponsor SOPs and/or contractual obligations.
Schedule, attend, and respond to all requests for SLVs, SIVs, and IMVs.
Serve as mentor to new CRCs and assistants.
July 2006 - June 2013
LEAD CLINICAL RESEARCH COORDINATOR
Clinforce Inc, Durham, NC
CRCs with various administrative tasks for Phase III-IV trials
Created, completed, organized, and meticulously maintained subject source data and regulatory files to ensure all documentation remains audit ready, patient recruitment.
Conducted ICF process per site SOPs, GCPs, Sponsor, and applicable regulatory requirements. Schedule, attend, and respond to all requests for SLVs, SIVs, and IMVs.
Serve as mentor to new CRCs and assistants.
Collected vitals and performed phlebotomy, blood draws, labs, and EKG, as required per protocol. Adverse Event and Severe Adverse Event and Drug accountability and drug dispensing.
Completed data entry and addressed any queries/discrepancies utilizing various EDC systems.
January 2002 - January 2006
CLINICAL RESEARCH COORDINATOR
Health and Research Associates, Atlanta, Ga
May 1998 - January 2002
Research Associate /Research Coordinator
UPMC Obesity Nutrition Research
EDUCATION
January 1985-May 1999
Associate Of Science Associate
Associate in Liberal Arts
Allegheny Community College, Pittsburgh, PA
CERTIFICATIONS
Good Clinical Practice (GCP)
FDA Audit Training
Saf-T-Pak( IATA)
Basic Life Support
Medical writing of clinical trial documents
Grant writing Master (grant Research, Grant writing, and Grant organization)
Member of AMWA
.
Contact this candidate