Gbolahan Remi Molake

Staten island, NY

adzu56@r.postjobfree.com

347-***-****

LinkedIn: www.linkedin.com/in/remi-mo

SUMMARY

Clinical Study Associate with over 8 years of experience managing and monitoring various aspects of clinical trials. Adept at ensuring compliance with study protocols, SOPs, ICH-GCP, and FDA guidelines. Proven ability to provide guidance at site and project levels, maintain audit readiness standards, and support study teams. Experienced in oncology, cardiovascular, respiratory, urology, and dermatology studies.

EDUCATION: York College, City University of New York, Jamaica, NY, Bachelor of Science

EXPERIENCES

Daiichi Sankyo Inc.

Oct 2021- Jul 2023

Sr Clinical Study Associate

Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities to ensure they meet objectives and quality standards.

Monitor the performance of clinical trial sites to ensure they comply with the study protocol, quality measures, and work scope, all while adhering to specified timelines.

Review monitoring visit reports to identify potential site non-compliance and monitoring deficiencies. Ensure that the sponsor is appropriately overseeing the study.

Collaborate with Study team to ensure the study is always prepared for audits and inspections. Address any findings from audits or inspections in a timely and appropriate manner. Participate in site audits when required.

Provide tracking and oversight to the Vendor handling lab logistics and any other vendors deemed appropriate.

Reconcile Various Study trackers generated by the CRO and Vendors

Identify and resolve study-related issues and risks. Escalate critical issues as necessary to ensure their timely resolution. Provide proactive support to sites to encourage patient enrollment and compliance with study timelines.

Evaluate study budget and Support Fair Market Value process.

Ensure timely data collection, source document verification, and resolution of queries at site levels to maintain data integrity.

PRA Health Sciences/ICON

May 2018 – Sept 2021

Clinical Research Associate II

Managed and monitored different aspect of clinical trials according to the study protocol and ensure that sites adhere to regulatory standards, ICH-GCP guidelines, and Good Pharmacoepidemiology Practice (GPP) as applicable to the study.

Verify the qualification of potential clinical trial sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.

Verify the handling of investigational products, including inventory, reconciliation, storage, and security. Ensure compliance with IP-related regulations and procedures.

Assess factors that might affect patient safety and clinical data integrity, including protocol deviations/violations and pharmacovigilance issues.

Conduct source document review of relevant site source documents and medical records to verify the accuracy and completeness of clinical data entered into the case report form (CRF).

Verify that the process of obtaining informed consent from study subjects/patients has been correctly and adequately performed and documented, ensuring patient confidentiality.

Ensure that safety-related information is reported in a timely manner at the assigned investigative sites, in compliance with regulatory requirements.

Document all activities, including confirmation letters, follow-up letters, trip reports, communication logs, and other project documents in compliance with Standard Operating Procedures (SOPs) and the Clinical Monitoring Plan/Site Management Plan.

Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met. Act as the primary liaison with site personnel.

Ensure that staff at assigned sites undergo essential training and remain in accordance with relevant requirements. Verify that the Principal Investigator (PI) and site personnel have a comprehensive grasp of the study protocol as well as all systems required. Conduct re-training when violations occur.

Reconciled the Site Master File with the Trial Master File and maintain site's regulatory binder and corresponding TMF.

PRA Health Sciences/ICON

February 2016 – May 2018

Clinical Research Associate I

Conducted site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-3 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines.

Conducted all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives.

Ensured quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Review and reconcile the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Ensure that essential documents are archived in accordance with local guidelines and regulations and that ISF contents match the TMF.

Prepared and submit written reports, both monitoring and administrative, in a timely, concise, and objective manner.

Identified issues that may impact enrollment and recruitment timelines and provide objective comments regarding these issues.

Peace Care Center, Staten Island, NY

May 2014- February 2016

Clinical Research Coordinator

Identified issues that may impact enrollment and recruitment timelines and provide objective comments regarding these issues.

Collaborates with principal investigator and research team on the development of new research projects, databases and protocols or new department /service initiatives.

Served as the contact person for all investigators and research coordinators within radiology and from other departments who are interested in utilizing radiology imaging for clinical research purposes. This includes proactively addressing any potential issues, facilitating database enhancements, and overseeing/managing special requests.

Assisted faculty within the Department of Radiology in the preparation of institutional review board (IRB) forms, case report forms (CRF), IND submissions and maintenance of study documentation.

Conducted systematic audits to ensure data collected is consistent with source documents and is following external sponsor/regulatory requirements.

Maintained and organized study documentation and records. Compiles data and assists in consolidating /analyzing data for presentation.

Ensured that all research billing requirements are met per protocol and respond to all related correspondence in a timely manner.

SKILLS

Microsoft Outlook Suite, Mac OS, Google + applications, OneNote, SQL

Excellent communication, presentation, and interpersonal skills

Strong problem-solving abilities with a high level of critical thinking skills.

Working knowledge and experience in FDA, ICH-GCP, applicable SOPs/Guidelines and other applicable regulatory requirements

Medidata RAVE, Inform, CLIN Plus

CTMS: iMedidata, Oracle

Veeva Clinical: Submissions, Vault and Quality Docs

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