Clinical Research Administrative Support
Resume:
CYNTHIA MOYE
Baltimore, MD *****
***************@*****.***
Dependable Coordinator provides excellent office management and administrative support. Possesses strong communication and interpersonal skills with demonstrated ability to manage competing priorities and meet deadlines. Creative problem solver with strong analytical and critical thinking skills. Work Experience
Clinical Research Coordinator Trial Manager
ThermoFisher-Rockville, MD
September 2018 to July 2024
Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution
Collaborates with the PI and sub-I to develop study forms, and create protocols to review database information in IRT, and establish guidelines for monitoring data quality control Assists the principal investigator in developing the protocol budget, in collaboration with Research Administration and regulatory
Work with CRA, Sponsors and other Trial managers in the reporting and accounting for regulatory tasks and study budgets/
Responsible for the recruitment and oversight of coordinator staff as well as ensuring that staff has completed mandatory training promptly
Develops and oversees a program-specific onboarding and orientation process and participates in annual performance evaluations and competency assessments of research staff Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists, and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations, and site SOPs
Assists the principal investigator in preparing manuscripts for publication Oversees registration of oncology and infectious disease protocol patients with QACT, study group registrar, and pharmaceutical company as outlined in the protocol Collect, process, and ship blood/urine specimens at scheduled patient visits Completed and maintained case report forms per FDA guidelines and reviewed them against the patient's medical record for completeness and accuracy
Adhere to Good Clinical Practices, Alcoa FDA Standards. Reviewed documents, files, transcripts, and other records to assess compliance and potential risk. Publicized health and safety program requirements and mentored employees on the critical nature of compliance.
Managed the full life cycle of assigned audits in alignment with departmental procedures, delivering progress and closing reports to senior management and clients. Risk management compliance efforts, reporting, and audits. Defined and developed policies and procedures for consumer reporting and privacy practices. COVID Intake Manager Partime
CCBC-Catonsville, MD
March 2021 to January 2023
Initiated prompt communication with people exposed to COVID-19 (contacts) through text, phone calls, email, and other communication platforms, as necessary Provided guidance on recommended infection prevention and control practices at a home or non-home residential setting as found on CBC's Interim Infection Control Guidance Verified contact's identity during communications and prior to disclosing confidential information Ensured confidentiality and carried out efforts to locate and communicate with clients in a manner that preserved the confidentiality and privacy of all involved Notified the contact of exposure to COVID-19, following a script to provide COVID-19 education Conducted notification of exposure in a manner that maintained the confidentiality of the patient and ensured that the identity of the patient was NOT disclosed Welcoming patients, taking their medical history, and filling out medical records Answering the phone, filling out medical insurance forms, handling correspondence and bookkeeping- related tasks
Scheduling appointments, arranging for hospital admission or laboratory services Teaching patients about special diets, medication, and treatment procedures Vital sign administration
Preparing patients for their examination and then assisting the doctor during physical and virtual examinations of patients
Administering medications both orally and injectable Prescription refills
Venipuncture and IV insertion.l.
Monitor frequency and effectiveness of the on-site visits of the customer success staff with designated nursing facility team leaders and staff.
Manage the process of new customer on-boarding and training Performance Research Coordindator / Compliance Trial Manager Manager Greenbaum Cancer Center-Baltimore, MD
September 2014 to December 2018
Performed quality and compliance for assigned protocols in the country and oversaw CRAs and/or CTCs and training compliance
Performed clinical trial education to sites and acted as the country POC for programmatically outsourced trials for assigned protocols
CRC duties of venipuncture, vital signs, medication management, and administration of oral, injectable, and topical IP for Onclogy .
Responsible for relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners Oversees country and site validations, site selection, and recruitment in assigned protocols Reviewed laboratory data and communicated abnormal values to the PI/SI and care provider Administered study drug therapy and maintained the study drug dispensing log Reported all serious adverse events to the principal investigator, sponsor, and IRB per protocol On-site monitoring maintained accurate documentation including regulatory documents, signed informed consent forms, relevant IRB approvals, source documentation, and drug dispensing log Conducted site assessment visits to ensure research sites implement the study per protocol and provide guidance for operational management
Developed and maintained a network of clinical and scientific contacts Developed and led the personal and professional development programs of clinical team personnel Developed or contributed to protocol development, as necessary Conducted quarterly performance reviews and continuous employee development Provided a leadership role in developing, implementing, and evaluating the conduct of studies Proactively engaged senior clinical management in program risk discussions and provided well-thought- out solutions to issues.
Lab Coordinator/Health Educator
Unity Healthcare-Washington, DC
December 1997 to September 2014
Provided laboratory coordination, supervise 28 employees, and prepared and monitored schedules and budgets, including obtaining personal data, medical history, and insurance coverage Performed quarterly QA/QC for data collection with officers and data collectors Gathered urine and breath samples using aDepartment of Transportation-approved breathalyzer and drug test
Performed appropriate Phlebotomy technique per ASPT regulations Coordinated all lab equipment, supplies, and cadaver utilization, monitoring student adherence to institutional and departmental safety policies
Monitored and maintained lab equipment using Statistical Process Control Maintained order and cleanliness of laboratory; ensured lab equipment is in working order - including model trimmers and polishing units
Point of Care testing,managment and training .
Conducted research experiments to test and validate new technologies Investigated and resolved issues related to laboratory processes and procedures. Prepared and examined specimens using variety of instruments, histologic and molecular diagnostic techniques.
Engaged in instrument maintenance and basic troubleshooting of LC-MS/MS, serving as primary operator of LC-MS/MS and reviewing QC and calibrator performance for assay integrity. Evaluated team meme work for quality, ethics and compliance with project specifications. Developed and implemented plans and protocols for ongoing research, special projects and testing protocols.
Maintained budget guidelines, approved all expenses and submitted timely financial reports. Conveyed technical information in easily understood terms for non-technical individuals. Developed and implemented standard operating procedures to verify quality control Prioritized work assigned, maintained accurate records of work performed and initiated corrective action in case of defective records or inadequate care plans Recorded and interpreted laboratory results to present to senior colleagues Prepared and examined specimens using variety of instruments, histologic and molecular diagnostic techniques
Investigated, compiled and modeled information for detailed project proposals Developed and implemented plans and protocols for ongoing research, special projects and testing protocols
Crisis prevention
Suicide initially intake phone assessment and form completion referral management and utilization management.
Prior authorization for medication and mechanical devices. scheduled travel and reimbursed patients for trial participation Education
Bachelor's degree\ Master's Degree in Public Health Capella University
February 2022 to Present
Certification in Medical Assisting
Applied Career Training Center - Rosslyn, VA
July 1997
Skills
• Healthcare Management Regulatory Standards
Medical terminology Internal Audits
Clinical research Conducting Investigations
Microsoft Office Document Analysis
GCP Quality Control
Corrective Action Planning Advisory Support
Documentation Compliance Risk Reviews
Data Evaluation Technical Compliance
• Quality control
• Quality assurance
• Customer service
• Data collection
• Supervising experience
• Laboratory experience
• Operating systems
• Recruiting
• Compliance management
• Hospital experience
• EMR systems
• Specimen collection / processing
• GCP
• Documentation review
• Medical terminology
• Clinical research
• Epic
• SharePoint
• Leadership
• Research
• Clinical trials
• Medical records
• Operations management
• Office management
• Vital signs
• Windows
• Analysis skills
• Clerical experience
• Mentoring
• Relationship management
• Bookkeeping
• Communication skills
• Computer skills
• Microsoft Excel
• FDA Regulations
• Outpatient
• Oncology
• Patient monitoring
• Typing
Certifications and Licenses
Paralegal Certificate
IATA Certification
Pharmacy Technician Certification
RMA
CPR Certification
First Aid Certification
Additional Information
Risk Management and project Mangement
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