Houston, Texas 832-***-**** ad15m9@r.postjobfree.com

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AMINAT OJO

PROFESSIONAL

SUMMARY

Dedicated and results-driven Clinical Research Professional with 8 years of progressive experience in clinical research, complemented by prior role as a Clinical Research Coordinator. Expertise includes protocol development, site selection, rigorous data monitoring, and a proven ability to ensure strict adherence to regulatory standards and GCP guidelines. Proficient in fostering cross-functional collaborations, leading teams, and mentoring junior team members. Possesses a strong commitment to maintaining data integrity and patient safety throughout complex clinical trials. Ready to leverage extensive background and leadership skills to drive the success of future research endeavors.

SKILLS

Expert knowledge in CTMS (Siebel, Veeva Vault), EDC (Medidata Rave, inform, OCRDC)

Proficient use of eTMF (Veeva Vault)

Sound understanding of ICH/GCP guidelines

SOP Adherence

Possess strong verbal/analytical/writing skills.

Ability to multitask while exhibiting leadership qualities and maintaining professional decorum

Experience in Microsoft Office Suite

Excellent communication skills and interpersonal skills.

THERAPEUTIC EXPERIENCE

Oncology: Breast, Melanoma, Pancreas, Non-Small Cell Lung,

Cardiovascular: Acute Congestive Heart Failure, Cardiovascular Disease

Respiratory: COPD, Asthma

CNS: NMOSD, Seizure Disorders, Migraine

Medical Device: Glucometer, Cardiac Stent, Pulse Oximeter

Endocrinology: Chronic Renal Failure

Ophthalmology: Glaucoma, Presbyopia, Dry Eye Syndrome

Dermatology: Acne, Plaque Psoriasis

WORK HISTORY

SENIOR CLINICAL RESEARCH ASSOCIATE 06/2023 to Current

HORIZON (AMGEN)

Participates in the development, execution, completion, and reporting of clinical trial(s) according to the regulations, on time and within budget.

Assists in drafting study related documents (protocol, informed consents, study plans, etc.)

Writes, reviews, and / or provides input to study plans and guidelines.

Assists in start-up activities of clinical trials including Investigator Meetings, selection of trial sites and investigators.

Assists in managing CROs / Functional Service Providers (FSP) under the direction of study managers.

Attends co-monitoring visits as needed.

Conducts Co-monitoring visits.

Reviews monitoring visit reports, escalates issues and works directly with CRO and secondary vendors to ensure appropriate follow-up and resolution of findings.

Oversee CRO’s vendors and identifies issues and risks, escalates items as necessary, and works directly with CRO / vendors to ensure appropriate follow-up and resolution of findings.

Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources.

Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants.

Manages trial related materials and vendors, e.g., investigational product supplies, ancillary supplies, central laboratories, central IRB, etc. as assigned.

Assists with the electronic trial master file (eTMF) processes including set-up and quality checks.

Ensures the quality control of critical documents.

Assist with CTMS updates for assigned trials.

Collaborates with CRO/FSP counterpart on an ongoing basis.

Performs monitoring (PSV, SIV, IMV, COV), as needed, of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant.

SENIOR CLINICAL RESEARCH ASSOCIATE 11/2021 to 06/2023

VISUS THERAPEUTICS

Ensured site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.

Anticipated and identified site issues that could affect timelines and develop alternative solutions.

Ensured clinical trial management systems containing all site-specific information are maintained and kept current.

Ensured timely payment execution for assigned sites/study(s) according to the clinical study contract.

Ensured adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Visus (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.

Stayed abreast of new and/or evolving local regulations, guidelines and policies.

Ensured audit and inspection readiness of assigned sites.

Advised on pre-audit activities for GCP requirements.

Coached and mentored CRAs and provided input into their development.

Reviewed data of assigned sites/studies according to the Monitoring Plan and in accordance with the study timelines and objectives.

Provided feedback on investigators/sites on an on-going basis based on the site performance.

Collaborated with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phase.

Interacted and built professional and collaborative relationships with peers and sites.

Managed activities as assigned by the Clinical Trial Manager.

SENIOR CLINICAL RESEARCH ASSOCIATE 10/2018 to 11/2021

ICON

Tracked enrollment status reports to ensure study stays on track to meet enrollment goals.

Tracked study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team.

Conducted routine performance assessment visits for less experienced CRAs to ensure monitoring meets ICON standards.

Served as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues.

Provided direct support to the Clinical Team Manager by assisting with reviewing monitoring visit report and other managerial tasks.

Worked with sponsors, study sites and CRAs to resolve discrepancies.

Reviewed outstanding data reports and worked with CRAs to ensure data collection is met per contractual guidelines.

Assisted sponsor, study sites, and CRAs with audit preparation.

Attended sponsor calls and internal team calls to stay informed of current study issues.

Performed and coordinated assigned aspects of the clinical monitoring process.

Conducted site visits to determine protocol and regulatory compliance, and prepared required documentation.

Developed collaborative relationships with investigative sites and sponsor(s).

Performed study-specific training with project team.

Developed study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data.

Completely expense report in a timely manner.

Prepared and attended investigator meetings.

CLINICAL RESEARCH ASSOCIATE II 07/2015 to 10/2018

ICON

Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.

Assisted sponsor and study sites with audit preparation and quality issues.

Conducted site visits to determine protocol and regulatory compliance.

Completed monitoring visit report for assigned studies/sites in a timely manner.

Attended internal team calls to stay informed of current study issues.

Developed collaborative relationships with investigative site and sponsor personnel.

Reviewed site Regulatory Binder for accuracy and completeness.

Reconciled the Regulatory Binder with the Trial Master File (TMF).

Conducted reconciliation and accountability of investigational products.

Generated outstanding data and query reports via the EDC.

Completely expense report in a timely manner.

Prepared and attended investigator meetings.

CLINICAL RESEARCH ASSOCIATE 10/2014 to 07/2015

INVENTIV HEALTH

Performed clinical study site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Protocol and Monitoring Plan.

Developed strong site relationships and ensured continuity of site relationships through all phases of the trial.

Gained an in-depth understanding of the study protocol and related procedures.

Performed remote and on-site monitoring & oversight activities.

Conducted site visits including but not limited to site selection, initiation, monitoring and close-out visits.

Completed visit reports appropriately in a timely manner.

Collected and reviewed required regulatory documents for study start-up.

Communicated with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation and overall site performance.

Managed and maintained information and documentation in CTMS, eTMF and other systems as appropriate per timelines.

CLINICAL RESEARCH COORDINATOR 05/2012 to 10/2014

MD ANDERSON CANCER CENTER

Facilitated and coordinated the daily clinical trial activities.

Screened, recruited and enrolled patients/research participants.

Coordinated protocol related research procedures, study visits, and follow-up care.

Reviewed each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.

Fulfilled all requirements and procedures set forth by study lab manual, study reference manual.

Knowledgeable of the informed consent process as well as a thorough understanding of the study protocol to be able to answer all questions pertaining to the study posed during the informed consent process.

Trained study subjects in their responsibilities (i.e., subject diary completion, and dosing of study product).

Ensured study-related laboratory reports and patient results are reviewed by an investigator in a timely manner.

Kept track of Protocol Amendments, Clarification letters, and study updates and implement updates accordingly.

Attended Investigator meetings requiring travel and report pertinent information back to research team members.

Coordinated and facilitated monitoring visits.

Created and maintained study source documents.

Reported and documented AE and SAE’s following protocol and site’s SOPs.

Completed all training and study modules assigned per study in a timely manner.

Maintained drug accountability, logs and inventory of study product and supplies.

Maintained Subject logs throughout the study (screening logs, enrollment logs, subject ID logs etc.), assisting with regulatory documents as needed.

Entered study data into the EDC system, following eCRF study guidelines.

Responded to data clarification requests and queries in a timely manner

EDUCATION

Bachelor of Science, Computer Information Systems, 06/2011

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