Your Name
Summary
Knowledgeable Clinical Research Associate experienced in onsite and remote monitoring. Action-oriented with a strong ability to communicate effectively (both written and oral) with all stakeholders as demonstrated by serving as a liaison between sites and sponsor. Ensures trial sites are compliant with protocol requirements and the data captured is accurate by performing case report form review, query generation and resolution. Efficient in maintaining patient safety, regulatory compliance, and data integrity.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
Arthrex, Inc.
Sandy Springs, SC
08.2021 - Current
- Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Build awareness of features and opportunities of study to site.
- Collaborate and liaise with study team members for project execution support as appropriate.
Advanced Emergency Medical Technician
Grifols Inc.
Battle Creek, MI
08.2017 - 08.2021
- Initiated and executed a plan of care based on patient assessments
- Collected pertinent information from patient, family, medical records and prescriptions regarding patient's present and past medical history
- Completed detailed patient care reports with supporting required documentation.
- Obtained IV access when needed
- Administered the appropriate medications to patients per the hospital protocols
- Maintained positive working relationships with other emergency personnel such as nurses, doctors, and patient families
In-House CRA I
Ergomed
Cary, NC
08.2020 - 07.2021
- Monitored site performance and implemented action plans for sites not meeting expectation, in conjunction with the lead CRA
- Performed Case Report review, query generation and resolution against established data review guidelines
- Assisted with the coordination of study visits and shipment of drug and laboratory samples
- Served as contact for project team and investigative sites
- Assisted lead CRAs with preparation for site visits (i.e. running reports, QC of files, resolving action items from previous visits)
- Managed sites to ensure subjects are complying with protocol requirements, study visits, and timelines
- Liaised with the project team and others to distribute and track clinical trial supplies e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment
- Worked in a timely manner in accordance with all the activities specified in the agreed study budget
- Assisted Senior CRAs with Study File Notebook and drug accountability
- Performed visits either as the primary monitor or as the co-monitor as required by the monitoring plan
Clinical Trial Administrator
LabCorp
City, STATE
07.2019 - 08.2020
- Assisted in the preparation of study site specific materials in accordance with relevant SOPs
- Ensured site correspondence was filed for Sponsor review
- Assisted CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits)
- Provided query summary reports to sites to ensure resolution in a timely manner.
- Assisted Senior CRAs, CRA-2 and CRA-1 with the resolution of open site issues.
- Maintained the electronic Trial Master File (eTMF)
- Prepared and sent study materials to investigator sites
- Attended study meetings and arranging investigator meeting arrangements
Education
Paramedic - Emergency Medical Services
Cape Fear Community College
Wilmington, NC2019
Bachelor of Arts - Chemistry
University of North Carolina Wilmington
2017
Associate of Science - Chemistry
Cape Fear Community College
2015
Skills
- ICH/GCP
- Onsite Monitoring
- Remote Monitoring
- EDC
- IVRS/IXRS
- CTMS
- ETMF
- LabLink
- Drug Accountability
- Essential Documents
- Source Data Verification
- Source Data Review
- Remote Data Review
- Serious Adverse Event (SAE) reporting
Certification
- Paramedic: P114912
- Pre-Hospital Trauma Life Support
Timeline
Clinical Research Associate
Arthrex, Inc.
08.2021 - Current
In-House CRA I
Ergomed
08.2020 - 07.2021
Clinical Trial Administrator
LabCorp
07.2019 - 08.2020
Advanced Emergency Medical Technician
Grifols Inc.
08.2017 - 08.2021
Paramedic - Emergency Medical Services
Cape Fear Community College
Bachelor of Arts - Chemistry
University of North Carolina Wilmington
Associate of Science - Chemistry
Cape Fear Community College
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