Clinical Research Associate

Ikechukwu Iphie

Clinical Research Associate II

Email: *****.***@*****.*** Phone: +1-713-***-**** Location: Houston, Texas

Professional Summary:

I am a Clinical Research Associate with over 8 years of experience in managing and coordinating clinical trials across multiple therapeutic areas. My expertise includes designing study protocols, conducting site assessments, ensuring regulatory compliance, and overseeing data collection and analysis. I have a proven track record of optimizing clinical operations, monitoring site performance, and ensuring adherence to timelines and budgets. Skilled in managing investigator sites, training clinical staff, and handling patient recruitment, I am committed to driving successful clinical trial outcomes. I excel in collaboration with cross-functional teams and stakeholders, ensuring quality, patient safety, and regulatory adherence throughout all stages of clinical research.

Skills:

Clinical Trial Management

Clinical Study Design, Site Monitoring, Protocol Development, Site Selection, Subject Recruitment, Site Initiation, Regulatory Compliance, Trial Phases

Data Management & Analysis

Data Collection, Database Management (Medidata Rave, Oracle), Clinical Data Review, Query Management, Data Validation, Statistical Analysis

Regulatory Compliance

Good Clinical Practice (GCP), ICH Guidelines, FDA Regulations, Informed Consent Process, Ethics Committee Submissions, Risk Management

Project Management Tools

Trello, Asana, Microsoft Project, JIRA, Slack, Monday.com, Basecamp

Communication & Collaboration

Stakeholder Management, Team Coordination, Cross-Functional Team Collaboration, Conflict Resolution, Presentation Skills, Reporting & Documentation

Clinical Software & Tools

eCRF (Electronic Case Report Form), Veeva Vault QMS, LabCorp, ClinOne, Medidata Rave, RedCap, CTMS (Clinical Trial Management System), Covance

Patient Safety & Monitoring

Adverse Event Reporting, SAE (Serious Adverse Event) Management, Patient Monitoring, Safety Protocols, Risk-Based Monitoring, Compliance Audits

Professional Experience:

Fortrea (formerly) Labcorp, Houston, Texas, United States of America - Nov 2022 – Aug 2024

Sr. Clinical Research Associate II

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits. Liaise with vendors and other duties, as assigned.

Responsible for all aspects of site management as prescribed in the project plans.

General On-Site Monitoring Responsibilities. Ensure audit readiness at the site level

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.

Ensure the resources of the Sponsor and organization are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy.

Review progress of projects and initiate appropriate actions to achieve target objectives. Manage small projects under direction of a Project Manager/Director as assigned .

Negotiate study budgets with potential investigators and assist the legal department with statements of agreements as assigned.

Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned.

Biorasi, Aventura, Florida, United States of America – Apr 2021 – Nov 2022

Sr. Clinical Research Associate I

•Scheduled, Planned and Conducted Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.

•Wrote Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.

•Managed the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution

•Provided project updates to project management team.

•Organized delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.

•Performed investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.

•Assisted with, prepare for, and attends Investigator Meetings for assigned studies.

•Reviewed study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.

•Collected and reviewed essential study documents from site for filing in eTMF.

•Administered protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.

Biorasi, Aventra, Florida, United States of America – Aug 2018 – Apr 2021

Clinical Research Associate II

Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/ or line manager.

Conducted routine site monitoring visits to ensure compliance with clinical trial protocols, regulatory requirements, and GCP standards.

Managed patient recruitment and retention strategies to ensure optimal enrollment and minimize dropout rates at clinical sites.

Reviewed and verified the accuracy and completeness of data collected at clinical sites, ensuring timely resolution of discrepancies.

Collaborated with cross-functional teams, including investigators and vendors, to address project-related issues and ensure timely trial execution.

Assisted in the development and implementation of corrective and preventive action plans (CAPA) to address protocol deviations and ensure quality control.

Biorasi, Aventura, Florida, United States of America – Aug 2016 – Aug 2018

Clinical Research Associate I

•Monitored study site activities to ensure adherence to Good Clinical Practices (GCP), SOPs, and study protocols.

•Reviewed case report forms (CRFs) and compared them against source documents for accuracy and completeness.

•Ensured proper documentation and reporting of adverse events in compliance with regulatory requirements.

•Managed clinical trial monitoring, site evaluation and initiation, data review, and regulatory document preparation, while generating site visit reports.

•Ensured timely submission of site visit reports, in accordance with management guidelines and timelines.

•Ensured adherence to study timelines and protocol requirements throughout the trial process.

•Acted as a liaison between clinical sites and sponsors, addressing questions or concerns related to clinical studies.

•Monitored and ensured the completion of follow-up items in a timely manner between site visits.

•Oversaw monitoring of Phase I-IV clinical trials, ensuring compliance with all relevant protocols and regulatory standards.

Biorasi, Aventura, Florida, United States of America – Mar 2016 – Aug 2016

Clinical Trial Assistant

•Managed the electronic Trial Master File (eTMF), ensuring accurate and timely documentation.

•Collected, input, and performed quality control on data using Excel, applying strong analytical skills to ensure data integrity.

•Conducted routine site visits to assess compliance with clinical trial protocols and ensure accurate data collection.

•Provided guidance and training to site staff on study protocols, regulatory requirements, and best practices in clinical research.

•Ensured the timely and accurate submission of study documentation, including regulatory documents, CRFs, and monitoring visit reports.

•Coordinated the preparation and submission of study-related materials to Institutional Review Boards (IRBs) and regulatory authorities for approval.

•Collaborated effectively with research team members, coordinating efforts and ensuring clear communication throughout the research process.

•Coordinated clinical documentation for prospective subjects, including managing informed consent processes to ensure compliance and proper documentation

Therapeutic Experience

Dermatology: Skin Disorder- Rosacea(Phase IIa)

Cardiovascular: Atherosclerosis (Phase IIb), Hypertensive and Hypotensive Diseases Hypertension(Phase II)

Oncology: Solid Tumors - Breast (Phase II,III), Prostate (Phase III), Ovarian (Phase II)

Neurology: Neurodegenerative Diseases - Multiple Sclerosis (MS)(Phase II)

Neurology: Movement Disorders - Parkinson's Disease(Phase II)

Device: Diagnostic Procedure - Glucose Monitoring (Phase III)

Education

Bachelor of Medicine, Bachelor of Surgery (MBBS), Medicine and Surgery

Nnamdi Azikiwe University Awka, Anambra, Nigeria

Systems Experience

Microsoft Office (Excel, Word, Outlook, PowerPoint)

CTMS (IMPACT, InForm)

EDC (Medidata RAVE, OCRDC, IBM Clincal)

eTMF (Veeva Vault)

IWRS (Endpoint)

Language Capabilities

English - ILR 5 (Native or Bilingual)

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