Obinna Naana
Brooklyn,NY
Summary
To contribute to the overall success of a clinical trial using my experience, initiative, strong communication skills, and proficiency in clinical monitoring, Good Clinical Practice (GCP) and FDA regulations.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Senior Clinical Operations Manager
LB Pharmaceuticals, Inc.
08.2024 - Current
Junior Clinical Operations Manager
LB Pharmaceuticals, Inc.
01.2024 - 08.2024
- Shares responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
- Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research
- Interacts with our CRO, Clinical Trial Manager, Project Manager
- Lead contact with Phase 2 sites on managing enrollment
- Participate on weekly CRO/Internal team communications and progress reports / discussions regarding project risks and strategies with CROs, including but not limited to recruitment, site issues, etc
- Participate in meetings with CRO Executive Team when required
Clinical Research Associate
Reflow Medical
09.2022 - 02.2024
Clinical Research Associate
Cartesian Therapeutics
06.2022 - 06.2023
Clinical Research Associate
NeuroPace
02.2022 - 10.2022
Clinical Research Associate II
Large, Global Contract Research Organization
02.2020 - 08.2022
- Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records
- Issues, investigates, and resolves any data discrepancies identified during source verification activities
- Provides clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence and maintains thorough documentation and proper escalation of issues related to visit reports
- Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and applicable regulations
- Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview
- Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations
- Collaborates with cross-functional team members and study sites throughout all study phases
- Manages study contracts, requests/collects relevant investigator/site documentation (ie regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database
- Performs additional duties as assigned
Clinical Research Associate I
Large, Global Contract Research Organization
09.2018 - 02.2020
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
- Participated in the identification and recruitment of investigators
- Reviewed participant eligibility and documentation of consent
- Evaluated electronic data capturing systems for adherence to guidelines and protocol
- Checked drug storage procedures for compliance with protocols and SOP requirements
- Supported development and delivery of department training to maximize success of clinical research
- Monitored collection, accuracy and integrity of regulatory documents in site binder
- Established and maintains interpersonal relationships with patients, visitors and other hospital personnel, while assuring confidentiality of patient information
- Established drug trial methodologies and procedures to support business and clinical trial endeavors
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
Clinical Research Coordinator
Northwell Health
07.2017 - 08.2018
- Assisted the Director and PI in study feasibility assessments as requested
- Worked with the Regulatory Coordinator to ensure all documents needed to initiate the study and submit to the sponsor (e.g., FDA forms 1572, CVs, etc) are complete
- Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion
- Assisted in development of equipment binders, templates and help set up the laboratory
- Ensured and maintained the calibration of equipment per SOPs and maintained appropriate logbooks
- Processed blood and urine samples as per protocol requirements
- Obtained ECGs, as well as vital signs of blood pressure, pulse oximetry, temperature, respiration rate
- Assisted in maintaining and managing data entry into Electronic Data Capture software
- Assisted in preparing, managing and distributing clinical documentation and reports as needed
- Maintained study timelines
Education
Biology - General
The City University of New York
05.2017
Skills
- Site monitoring
- Clinical research
- Document management
- Study design
- Patient recruitment
- Developing training programs
- Staff development
- Team meetings
- Data filing and maintenance
- Administrative oversight
- Clinical operations
- Managerial experience
Certification
- GCP for Clinical Investigations of Devices, CITI Program, 10/01/22, https://www.citiprogram.org/verify/?w23d40bee-2fb5-4b0f-9f62-620ea46fa328-52163204
- ISO 14155:2020 Medical Device Standard, Biopharma Institute, 10/01/22
- HIPAA for Business Associates, EasyLlama, 09/01/24, https://easyllama.com
- Harassment Prevention: NY Non-Supervisor, EasyLlama, 10/01/24, https://easyllama.com
Timeline
Senior Clinical Operations Manager
LB Pharmaceuticals, Inc.
08.2024 - Current
Junior Clinical Operations Manager
LB Pharmaceuticals, Inc.
01.2024 - 08.2024
Clinical Research Associate
Reflow Medical
09.2022 - 02.2024
Clinical Research Associate
Cartesian Therapeutics
06.2022 - 06.2023
Clinical Research Associate
NeuroPace
02.2022 - 10.2022
Clinical Research Associate II
Large, Global Contract Research Organization
02.2020 - 08.2022
Clinical Research Associate I
Large, Global Contract Research Organization
09.2018 - 02.2020
Clinical Research Coordinator
Northwell Health
07.2017 - 08.2018
Biology - General
The City University of New York
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