Research Associate Clinical
Resume:
PROFESSIONAL SUMMARY
A highly skilled Senior Clinical Research Associate with 7 years of
cumulative experience of monitoring in various therapeutic areas. Possesses strong multi-tasking skills evidenced by exemplary performance in different portfolios. Proficient in the use of Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS). Experienced in coordinating schedules, results and documentation. Proven ability to work in a dynamic manner to deliver within stipulated and expected timelines
THERAPEUTIC EXPERIENCE
WORK HISTORY
Senior Clinical Research Associate, 06/2019 - Current Parexel
Houston, TX 77084
*********@*****.***
SKILLS
ROMOS OBOR
Medical Device- IVD, Heart Valve, Glucose Continuous Monitoring Device.
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• Cardiology – Hypertension, Congestive Cardiac Failure.
• Neurology - Diabetes Type II Phase III, Thyroid Disease-Phase III Oncology – Breast Cancer, Cervical Cancer, Pancreatic Cancer, Colorectal Cancer, AML, ALL.
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Endocrinology - Diabetes Type II Phase III, Thyroid Disease-Phase III
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• Ophthalmology- Macular Degeneration, Macular Edema, Glaucoma Infectious Diseases- COVID-19, Tuberculosis, Bacterial Meningitis. HIV/AIDS
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• Respond to site issues/findings identified during monitoring visits. Generate study updates and collect regulatory documents for Trial Master Files for different studies.
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Primary liaison between CRAs and project team, and participated in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools.
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Preparing trial-related documentation (protocols, Case Report forms, Investigator's brochure, Consent forms and documents, letters of agreements, confidentiality agreements), organizing IRB submissions with follow through to ensure successful outcomes. Assists and attends Investigator Meetings for assigned studies.
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Knowledge of CTMS, EDC, eTMF,
IVRS systems
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Sound understanding of ICH/GCP
guidelines
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Excellent written, digital, and
verbal communication skills
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• Team management
• Trial management
• Report writing
• Completing regulatory documents
Excellent communication and
interpersonal skills.
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• Organizational Skills
Clinical Research Associate II, 04/2015 - 06/2019
Parexel
Clinical Research Associate I, 06/2013 - 04/2015
Parexel
Maintaining and verifying information across multiple clinical databases.
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Responsible for conducting site visits (initiation, monitoring, and Close-Out) to the assigned investigational sites to ensure that study is being conducted according to the protocol, project plan, ICH/GCPs, and FDA regulations.
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Track Serious Adverse Events at assigned sites and ensured timely reporting to the sponsor and IRB.
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Conduct protocol training for staff at investigator site(s) during site initiation visit, to ensure that site(s) is/are equipped to conduct the clinical study.
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Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
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• Prepared accurate and timely trip reports
• Identified and completed follow-up of SAEs at study sites Independently performed CRF review, query generation and resolution against established data review guidelines on CTMS
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Confirmed study staff conducting the protocol have received the proper materials, instructions and training to safely enter subjects into the study and complete the protocol requirements
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Ensured subjects protection by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
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Ensured the integrity of the data submitted on CRFs or other data collection tools by careful source document review
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Ensured that Site Regulatory Documents are complete and current throughout the duration of the trial
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Performed Project Plans related to Clinical Monitoring responsibilities
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Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance
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Monitored assigned clinical trials following company SOPs and in accordance with GCP
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Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
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Tracked completed CRFs and set up systems whereby completed CRFs are rapidly entered into the database
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Research Coordinator, 02/2012 - 06/2013
Westbury Community Hospital
EDUCATION
Bachelor of Science, Microbiology
OAU
Ensured that queries generated during cleaning were responded to in a timely fashion
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Reviewed all SAEs, ensured Medical Director sign-off, that sites are notified and that all company procedures are complied with.
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Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
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Participated in departmental planning sessions, and SOP development
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Provided management to the clinical research assistants to ensure that their role and contribution were optimized.
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• Responsible for the management of assigned clinical trials sites Organized investigator's start-up meeting and study site initiation meetings
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Coordinated the movement of laboratory samples and the resulting data when central laboratory facilities are used
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Ensured procedures are in place for appropriate optimization of patients into the clinical trial
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Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
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Conducted clinical trial in accordance with protocol and recorded and monitored progress.
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Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
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Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
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Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
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Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
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Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
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Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
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