Clinical Research Coordinator at GDIT Support to Traumatic Brain Injury Center of Excellence (TBICoE) (2026-06 – Present)
Retrospective/Observation/Prospective Phase I-II
- Prepares requests for actions/proposals to include assisting with and providing coordination for grant proposal applications and their associated documentation and requirements as needed. Facilitates the flow and approval processes for relevant projects as needed or requested.
- Provides training for research assistants to recruit and pre-screen TBICoE clinical research study volunteers, administer study procedures, and obtain informed consent.
- Writes and drafts submission of clinical protocols, consent forms, and other documents to the scientific review committee, IRB, and other regulatory organizations, assisting Principal Investigators and Associate Investigators.
- Receives ongoing training with local HRPP for Site initiation visits, risk assessments, and protocol approvals.
Clinical Research Coordinator at Compass Government Solutions Support to TBICoE (2024-08 – 2026-06)
Retrospective/Observation/Prospective Phase I-II
- Prepares requests for actions/proposals to include assisting with and providing coordination for grant proposal applications and their associated documentation and requirements as needed. Facilitates the flow and approval processes for relevant projects as needed or requested.
- Provides training for research assistants to recruit and pre-screen TBICoE clinical research study volunteers, administer study procedures, and obtain informed consent.
- Writes and drafts submission of clinical protocols, consent forms, and other documents to the scientific review committee, IRB, and other regulatory organizations, assisting Principal Investigators and Associate Investigators.
- Creates SOPs, guidance, and tools for research assistance to use for study compliance.
- Develops internal logs and trackers for operational oversight for assigned studies.
- Maintains physical and electronic regulatory files related to assigned projects.
- Provides regulatory guidance and training to research staff and Principal Investigators.
- Assists with risk management oversight, quality control of EDC, and source documents.
- Maintains active communication with the sponsor on device oversight, maintenance, software updates, and data collection.
- Exports data to the sponsor and performs QC on all data captured.
Clinical Research Coordinator at Glacier Support Services, LLC (2023-03 – 2024-05)
Intervention Phase II
- Aided in eIRB regulatory delegations such as gathering institution-required documents for protocol submissions, creating internal and external source documents, and completing protocol submissions.
- Coordinated with the Military Training Facility (MTF) Core's lead CRC to conduct SIV and training for onsite and remote research staff from various locations.
- Provided training for research staff for upcoming studies in regulatory procedures and documentation following MTF and IRB requirements.
- Generated and assisted with the creation of study guides, MOP, SOP, procedure compliance tools, recruitment tools, and regulatory binders for research staff.
- Supported site manager and project manager with study start-up operational procedures and study close-out tasks, such as laboratory requirements of specimen collection to gather source documents.
- Functioned as a liaison between the stakeholders and site departments for strategic planning, resource allocation, and quality management on protocols.
- Mentored fellow CRCs and research staff on eIRB protocol submissions, regulatory requirements, and study operations.
- Collaborated with regulatory personnel to meet milestone requirements of protocol submissions, generating ICD, obtaining required memorandums, and revising protocols.
- Established a new regulatory filing system using NIH and GCP practice guidelines for the IHD Research team to implement for its current and future studies.
- Maintained skillsets of performing vitals and processing blood samples with routine training.
Clinical Research Coordinator & Regional Assistant CRC at Ventavia Research Group LLC (2022-06 – 2023-02)
Intervention Phase III/Cross Sectional and Control/Cohort
- Completed patient education and follow-up research visits for three different RSV pharmaceutical global research trials.
- Performed vitals on infants under the guidance of a licensed provider.
- Performed biospecimen collection on pediatric participants.
- Collaborated with sponsors and third-party organizations to complete data entry and data cleaning before interim analysis and data lock.
- Maintained training to perform blood draws and immunizations on pediatric and adult.
- Assisted the finance department in adjusting and processing stipends, confirmed receipt of subject stipends to accounts by the sponsor, and coordinated with the team to modify payment submissions.
- Scheduled and coordinated with subjects and the clinic to achieve a 91.2% compliance rate for date-capturing time points for active trials.
- Maintain compliance in reporting AEs and SAEs to the sponsor and PI within 24 hours of capturing the event, as required by GCP practices and IRB at designated time points.
- Managed calendars and conducted telephone study visits, onsite, and remote follow-up visits as per protocol to administer assessment data collection instruments.
- Coordinated with subjects to obtain medical records for transcription as required for follow-up visits.
- Accomplished reviewing medical records from medical facilities and transcribing data onto source documents following sponsors and GCP guidelines to obtain primary and secondary endpoints.
- Completed data entry into EDCs from electronic and paper source documents within 24-48 hours, using e-Complion and Veeva Vault.
- Executed site activities for upcoming Vaccine studies, such as the enrollment process.
Clinical Research Coordinator II at Henry Jackson Foundation, Murtha Cancer Center Program (2021-04 – 2022-06)
Observational Trials/Cohorts/Phase II-III
- Coordinated study procedures and activities with participating collaborators regarding ongoing and future studies.
- Administered and recruited subjects during the enrollment process for active studies, including pre-screening, biospecimen collection, and data collection.
- Performed regulatory administration tasks such as submitting pro
