Will Njoku

Clinical Research Professional with 10+ years of experience supporting Phase I-III pharmaceutical and clinical research studies across Dermatology, Oncology, CNS, Cardiovascular, Ophthalmology, Infectious Disease, Urology, and Medical Device therapeutic areas. Extensive experience conducting Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Site Close-Out Visits (COV) while ensuring compliance with ICH-GCP guidelines, FDA regulations, sponsor SOPs, monitoring plans, and protocol requirements. Proven ability to build strong investigator relationships, support patient recruitment objectives, perform source data verification, oversee investigational product accountability, and maintain high-quality study execution across multi-site clinical trials.

Senior Clinical Research Associate - Cromos Pharma

(2023-09)

• Conduct Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-Out Visits supporting Phase II-IV clinical studies.
• Serve as the primary point of contact for assigned investigative sites and maintain strong working relationships with investigators and site personnel.
• Perform source data verification, informed consent review, eligibility review, regulatory review, and protocol compliance assessments to ensure patient safety and data integrity.
• Support patient recruitment and enrollment efforts by partnering with investigative sites to identify and address recruitment challenges.
• Conduct site staff training and provide ongoing protocol guidance to investigators and study coordinators.
• Review investigational product storage, accountability, dispensing records, and reconciliation documentation to ensure protocol and regulatory compliance.
• Maintain accurate CTMS and eTMF documentation while supporting inspection readiness and quality initiatives.
• Prepare monitoring documentation and support timely resolution of site findings, protocol deviations, and action items.

Senior Clinical Research Associate - Biorasi

(2021-03 - 2023-03)

• Conducted Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-Out Visits across Phase I-III clinical studies.
• Managed site performance through source data verification, protocol compliance oversight, enrollment tracking, and query resolution activities.
• Prepared monitoring visit reports and follow-up letters documenting significant findings, action items, and corrective actions.
• Maintained regular communication with investigators and site personnel to support study objectives and patient recruitment goals.
• Coordinated investigational product accountability activities including receipt, storage, reconciliation, return, and destruction.
• Reviewed regulatory documentation and essential study records to ensure inspection readiness and protocol compliance.
• Participated in investigator meetings and study-specific training activities.
• Supported audit readiness initiatives and quality improvement efforts.

Senior Clinical Research Associate - PPD

(2020-01 - 2021-03)

• Monitored Phase II Cardiac Rhythm Management (Pacemaker) Medical Device studies while ensuring compliance with FDA regulations, ICH-GCP guidelines, and protocol requirements.
• Conducted site monitoring visits, source data verification, informed consent review, and regulatory review activities.
• Performed investigational product accountability reviews and maintained study documentation throughout study execution.
• Supported patient safety oversight and study quality initiatives through ongoing site management activities.
• Maintained strong investigator and site staff relationships to support successful study execution.

Clinical Research Associate II - PPD

(2017-02 - 2020-01)

• Conducted Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-Out Visits across Phase II and III clinical studies.
• Performed source data verification and reviewed study documentation to ensure protocol compliance and data integrity.
• Collaborated with investigators and site personnel to resolve operational issues and maintain study timelines.
• Supported patient recruitment and retention goals through proactive site management and communication.

Clinical Research Associate I - PPD

(2014-01 - 2017-02)

• Conducted monitoring activities in accordance with FDA regulations, ICH-GCP guidelines, sponsor SOPs, and study protocols.
• Trained site personnel on protocol requirements, adverse event reporting procedures, and study conduct expectations.
• Supported site activation activities through collection and review of regulatory documentation.
• Assisted with patient recruitment planning and enrollment support activities.

Clinical Research Coordinator - MD Anderson Cancer Center

(2012-02 - 2014-01)

• Coordinated patient visits, protocol-required procedures, and clinical trial activities.
• Collected, reviewed, and entered study data into EDC systems while maintaining data quality standards.
• Maintained regulatory binders and supported IRB submissions, amendments, and continuing review activities.
• Assisted with adverse event reporting, query resolution, and protocol compliance activities.
• Collaborated with investigators, sponsors, CROs, and multidisciplinary research teams to support successful study execution.

Bachelor of Science - Health Studies - Texas Southern University