Airen Evbuomvan
NEWARK,NJ
Summary
I am highly motivated and detail-oriented Clinical Research Associate with 5+ years of experience in fast-paced clinical trials environments. Dedicated to driving successful clinical trials by ensuring compliance with International Conference on Harmonization (ICH), Food and Drug Administration (FDA), and Good Clinical Practice (GCP) guidelines. Proficient in site visits, monitoring, and maintaining essential study documents. Skilled in handling multiple tasks, managing multiple site locations and building strong relationships with site staff.
Overview
8
8
years of professional experience
Work History
Clinical Research Associate II
CONCENTRICS RESEARCH
INDIANAPOLIS, IN
03.2021 - Current
- Conduct pre-study visits to evaluate the suitability of investigational sites for the investigation study and ensured the availability of facilities, resources, and qualified and experienced personnel
- Conduct initiation visits to open up investigational sites for clinical studies and ensured the investigational product has been received and that all study supplies and equipment have been received and ready for the commencement of the study
- Conduct monitoring visits to perform on-site review of files and records for source document verification and review of case report forms for completeness, accuracy, consistency and Protocol compliance
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Verify and ensure proper storage/handling, accountability and distribution of investigational product and trial supplies
- Review, track, and manage study documents (Case Report Forms (CRFs), Serious Adverse Event (SAE) reports, clinical notes, and enrollment logs) for accuracy and completeness, as well as query resolution
- Collects and reviews regulatory documents (1572s, Financial Disclosure Forms, CVs, Medical Licenses, etc.) for accuracy and completeness from study start-up through close-out
- Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
- Track and monitor enrollment at sites, initiating additional recruitment and retention strategies as required
- Ensure all the essential documents are maintained in the investigator site folder and is updated with new or amended documents and essential documents are forwarded to the sponsor for updating the TMF as necessary
- Collect, review, track, and ensure appropriate completion of site-specific study/essential documents
- Performs ongoing reconciliation of the Trial Master Files (TMF) content to site files
- Creating, maintaining, and reviewing monitoring standard operating procedures, monitoring tools for conducting monitoring tasks including: monitoring plans, monitoring reports, corrective and preventive action plans.
Clinical Research Associate I
CONCENTRICS RESEARCH
INDIANAPOLIS, IN
06.2019 - 03.2021
- Performed all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV)
- Participated in the site selection process with oversight from the Clinical Team Lead role
- Collected and reviewed regulatory documents (1572s, Financial Disclosure Forms, CVs, Medical Licenses, etc.) for accuracy and completeness from study start-up through close-out
- Monitored clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights and safety and welfare are protected; ensure data integrity through completeness, accuracy and legibility
- Monitored clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights, safety, welfare are protected; ensures data integrity through completeness, accuracy, and legibility
- Provided feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
- Ensured that sites fulfill their regulatory obligations and submit study documents for IRB review and approval
- Ensured data integrity through thorough site monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with company’s standard operating procedures (SOPs)
- Followed up with the site regarding timely completion and retrieval of CRFs and data correction forms
- Assisted sites in resolving regulatory document issues
- Ensure adequate study and regulatory documentation is maintained at the investigator site
- Verified appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment
- Documented and reported non-compliance in a timely manner
- Identify areas requiring follow-up and improvement at each clinical site, recommend corrective action and or conduct site re-training as needed
- Communicated findings from contact reports and monitoring visits to Clinical / Project Manager in a timely manner.
Clinical Trial Document Management Specialist
CONCENTRICS RESEARCH
INDIANAPOLIS, IN
03.2017 - 06.2019
- Assisted sites with initial regulatory document collection and IRB submission
- Tracked document status in CTMS, Trial Master File maintenance
- Worked with document systems and related groups to ensure groups are trained on document management systems or other agreed processes for electronic TMF document delivery
- Worked with sites to attain required regulatory documentation in a timely manner as required to meet timelines for study start-up
- Processes, scans, indexes, routes, and maintains files for CRFs, DCFs, and data management documents in accordance with SOPs
- Collected required study-specific site regulatory documents (Form 1572, financial disclosure forms, protocol signature pages, etc.) from participating research sites
- Quality checks documents and escalates as needed
- Prepared study-specific informed consent forms utilizing the IRB-approved template
- Coordinated the translation of the informed consent forms
- Ensured all site regulatory files are prepared for storage in accordance with SOPs and regulatory guidelines
- Submitted protocols, amendments, informed consents, advertising materials, continuing reviews, and protocol deviations/exceptions to the IRB.
Regulatory Document Specialist
Excellence Dermatology and Aesthetic Clinic
Orange, NJ
01.2016 - 03.2017
- Organized and maintained all the Investigator Site File (ISF) including set up, archival and creation of templates
- Track IRB letters and ensured that the documents referenced are placed in the ISF
- Performed Quality Control (QC) on all regulatory binders before the Quality Assurance (QA) audit of critical documents is completed
- Responded to any QA findings in critical documents audit to ensure proper documents are placed in the regulatory binder
- Created 1572 packets for all studies and ensured completeness prior to sponsor delivery and subsequent filing
- Maintained Delegation of Authority log real-time
- Maintained all current and historical copies of laboratory accreditations, reference ranges, staff Curriculum Vitae (CVs), medical licensures, and related forms
- Request updates when necessary
- Responsible for assisting in on-site and off-site storage including vendor budget as well as obtaining records for audits or as needed
- Ensured all protocol and protocol amendments are signed accordingly
- Responsible for all study and non-study specific approvals and study expiry tracking
- Responded to queries with regard to regulatory binders during study monitoring visits.
Education
Skills
- EDC Systems (Inform, Medidata Rave)
- IVRS (Clinphone, Balance)
- CTMS (eClinical, IMPACT)
- EMR eTMF (Veeva Vault)
- Microsoft Suites
- OneNote
- Teams
- Sharepoint
Timeline
Clinical Research Associate II
CONCENTRICS RESEARCH
03.2021 - Current
Clinical Research Associate I
CONCENTRICS RESEARCH
06.2019 - 03.2021
Clinical Trial Document Management Specialist
CONCENTRICS RESEARCH
03.2017 - 06.2019
Regulatory Document Specialist
Excellence Dermatology and Aesthetic Clinic
01.2016 - 03.2017
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