Acacia Harris
Fayetteville
Summary
Clinical Research Coordinator with experience since 2017, holding a Master of Science in Clinical Research and a Bachelor of Science in Pharmacy and Health Sciences from Campbell University. Completed a 10-week Clinical Research Associate internship at Womack Army Medical Center, enhancing skills in clinical trial management. Four years of active-duty service in the U.S. Army, maintaining an active Secret Security Clearance. Proven ability to manage complex research projects and ensure compliance with regulatory standards.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Compass Government Solutions
Fort Liberty
08.2024 - Current
- 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.
- Trained research assistants to recruit and pre-screen TBICoE clinical research study volunteers, administer study procedures, and obtain informed consent.
- Writes and drafts submissions of clinical protocols, consent forms, and other documents to the scientific review committee, IRB, and other regulatory organizations, and assists the Principal and Associate Investigators.
- Creates SOPs, guidance, and tools for research assistants to use for study compliance.
- Created internal logs and trackers for operational oversight for the leading study.
- Maintains physical and electronic regulatory files related to leading 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 on a regular basis, after performing QC on all data captured.
Clinical Research Coordinator
Glacier Support Services, LLC
Fort Liberty
03.2023 - 05.2024
- 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, MOPs, SOPs, 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 for 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 ICDs, 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 in its current and future studies.
- Maintained skill sets of performing vitals and processing blood samples with routine training.
Clinical Research Coordinator- Regional Assistant CRC
Ventavia Research Group LLC
Plano
06.2022 - 02.2023
- 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 patients and adults.
- 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 in 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
Henry Jackson Foundation, Murtha Cancer Center Program
Fort Liberty
04.2021 - 06.2022
- 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 protocol modifications, continuing reviews, revising case report files, and memorandums.
- Composed and assisted with the development of a REDCap database for a dental oncology repository.
- Processed and safely stored biospecimens within 24 hours of initial collection.
- Established study regulatory source documents and procedures for incoming CRCs, and facilitated meetings in conjunction with study sponsors (NCI, USU, WAMC).
- Performed quality checks for study folders, and operated supply inventory in collaboration with the sponsor's supply team.
- Supported the MCCB biobank repository study with eIRB protocol modifications, and biospecimen processing.
- Therapeutic areas consisted of dental, perioperative, and pathology departments.
- Assisted in preparing periodic reports summarizing progress of clinical studies.
Clinical Research Coordinator I
Duke OBGYN CRU Research
Durham
01.2017 - 01.2019
- Centralized in a urogynecology clinic, the managed research studies were implemented in the Raleigh clinic.
- Followed Duke’s IRB regulations and the Sponsor’s guidelines for study activities.
- Recorded and stored all source documents in study folders, medical health records (Epic and Maestro Care), and electronic data capture systems (Medidata Rave and REDCap).
- Provided oversight on prospective and retrospective studies with medical devices, the standard of treatment, and surgical procedures.
- Audited source documents, study binders, research supplies, and study enrollment logs while conducting internal quality checks.
- Performed study enrollment activities, completed study follow-up visits, and scheduled subjects for their research study visits.
- Performed blood draws, pregnancy tests, transcutaneous electrical nerve stimulation (TENS) units, vitals, and urinalysis tests.
- Operated in billing for research medications, laboratory orders, and subject compensation transactions.
- Administered submitting modifications and continuing reviews in eIRB.
- Facilitated the collection and processing of biospecimens from subjects, then prepared samples for storage and shipment.
- Trained clinical research assistants in research study activities.
- Maintained accurate, up-to-date tracking logs for all aspects of clinical research activities, including but not limited to adverse events, serious adverse events, concomitant medications, and lab results.
Clinical Research Associate (Internship)
Womack Army Medical Center, Dept. of Clinical Investigations
Fort Liberty
05.2016 - 07.2016
- Gain an understanding of data entry, IRB minutes experience, and research coordinator roles.
- Shadowed research coordinators in the patient enrollment process, onboarding meetings, and site presentations for new sites for pain management studies.
- Became knowledgeable in assessing regulatory documents, developing meeting agendas and minutes, and medical terminology.
Food Service Specialist
U.S. Army
Fort Liberty
04.2008 - 09.2012
- Executed administrative responsibilities, including budget management and supply ordering for dining facility.
- Monitored product expiration dates to guarantee freshness and quality.
- Managed monetary transactions in compliance with financial protocols.
- Maintained accurate records of food temperatures to adhere to health code regulations.
- Assisted with food preparation and meal assembly, following recipes and portion control standards.
- Provided prompt customer service by greeting guests upon arrival at restaurant.
- Ensured compliance with hygiene practices to maintain a safe working environment.
Education
Master of Science - Clinical Research
Campbell University
Buies Creek, NC12.2021
Bachelor of Science - Clinical Research
Campbell University
Buies Creek, NC08.2016
Skills
- Regulatory compliance
- Clinical protocol development
- Data collection and management
- Informed consent processes
- Quality control and assurance
- Electronic data capture
- Patient recruitment strategies
- Project management skills
- Team collaboration
- Attention to detail
- Staff training
- Risk assessment and mitigation
- Trial management
- Adverse event tracking and reporting
Certification
- Collaborative Institutional Training Initiative (CITI) program, 5515485
- Good Clinical Practice
- Responsible Conduct of Research- Biomedical Conduct of Research
- CRC Advance
- Revised Common Rule
- IRB Administration
- Shipping and Transport of Regulated Biological Materials
- OUSD P&R Human Research
- Basic Life Support, American Red Cross, 01LNU6H, 08/22/24
Honors Achievements Acknowledgments
- Army Achievement Medals (2 Medals)
- Good Conduct Medal
- Non-Article 5 NATO Medal
- Acknowledged in RTI International studies DEMAND and SUPER clinical research trials.
Timeline
Clinical Research Coordinator
Compass Government Solutions
08.2024 - Current
Clinical Research Coordinator
Glacier Support Services, LLC
03.2023 - 05.2024
Clinical Research Coordinator- Regional Assistant CRC
Ventavia Research Group LLC
06.2022 - 02.2023
Clinical Research Coordinator II
Henry Jackson Foundation, Murtha Cancer Center Program
04.2021 - 06.2022
Clinical Research Coordinator I
Duke OBGYN CRU Research
01.2017 - 01.2019
Clinical Research Associate (Internship)
Womack Army Medical Center, Dept. of Clinical Investigations
05.2016 - 07.2016
Food Service Specialist
U.S. Army
04.2008 - 09.2012
Master of Science - Clinical Research
Campbell University
Bachelor of Science - Clinical Research
Campbell University
Similar Profiles
Hannah AlexanderHannah Alexander
Benefits Verification Supervisor at Compass Revenue SolutionsBenefits Verification Supervisor at Compass Revenue Solutions
Madison Hill-StoskyMadison Hill-Stosky
General Laborer at Compass Access SolutionsGeneral Laborer at Compass Access Solutions
Chris ArkalisChris Arkalis
Service Team Manager at Compass Packaging SolutionsService Team Manager at Compass Packaging Solutions
Hannah M. LeClercHannah M. LeClerc
Camp Counselor at Mount Sequoyah CenterCamp Counselor at Mount Sequoyah Center
Crisma HowardCrisma Howard
Operations Manager at NIXD Fulfillment CenterOperations Manager at NIXD Fulfillment Center