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Clinical Research Manager

Location:
Grand Prairie, TX
Posted:
December 01, 2020

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Resume:

Aderinola Ogundimu, BS

Professional Summary

Over 6 years of experience providing support to the Clinical Operations Manager(s)/Study Lead(s) to manage and track key study deliverables. Supports study teams to ensure study deliverables are met and compliance with clinical protocols, their objectives and ICH and GCP guidelines. Experience in phases I, II and III clinical trials. Excellent knowledge of ICH and GCP guidelines.

Skills

• 6 years of clinical research experience.

• Detail oriented.

• Ability to work independently with minimal supervision.

• Ability to perform up to 80% of travel.

• Excellent record-keeping skills; good documentation practice. Ability to work very accurate and thorough

• Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.

• Experience with phases I, II and III clinical trials.

• Computer proficient with EDC experience.

• Excellent Verbal and Communication skills.

• Ability to work proactively.

• Ability to identify problems and assess the impact on timelines as well as come up with possible solutions is required.

• Ability to maintain excellent working relationships with a broad range of trial staff.

• Experience with risked based monitoring.

• 3 years of in vitro diagnostics experience working with Exact Sciences sponsor on blood sample collection trials to evaluate biomarkers in subjects with untreated solid tumors.

Therapeutic Experience

• Oncology: Solid Tumor, Acute Myeloid Leukemia, Colon Cancer, Prostrate Cancer, CAR-T and Sarcoma

• Neurology: Autism, Parkinson Disease, Multiple Sclerosis, ADHD and Major Depression

• Rare Disease: Cystic Fibrosis

• Infectious Disease: COVID-19 and Flu

• Medical Device: In Vitro Diagnostics (blood sample collection)

Work History

Senior Clinical Research Associate, 08/2020 to Current

Icon, Dallas, TX

• Provides training related to the protocol and management of the study.

• Performs routine monitoring of clinical study sites to ensure subject safety and protocol compliance.

• Verifies data entered on the CRFs is consistent with clinical notes and other source documents.

• Collects completed CRFs and queries from clinical sites.

• Writes monitoring visit reports

• Ensures the accountability of all test articles.

• Assists with study file audits and site audit preparation.

• Develops and maintains routine contact with clinical study investigators and staff.

• Assists with protocol, case report form and source document template development.

• Ensures compliance with appropriate regulatory (GCP, FDA, ICH, HBP, etc.) and internal guidelines.

• Assists with final report preparation.

• Assists with internal SOP/guideline development.

• Supplies forecasting and distribution.

• Communicates across departments and conducts project team meetings concerning status of the study and specific sites.

• Mentors and trains Clinical Research Associates on monitoring procedures and SOPs.

Clinical Research Associate II, 07/2018 to 08/2020

Icon, Dallas, TX

• Assisted in coordinating and conducting all aspects of study monitoring process (site initiation visits, interim monitoring visits, and close-out visits) to ensure site's compliance to the study protocol and applicable regulatory requirements.

• Prepared accurate and timely trip reports.

• Ensured compliance with GCP/ICH guidelines and regulations including review of all required essential documents necessary for study initiation to ensure audit ready study files throughout the duration of the study.

• Confirmed that study staff who will conduct the protocol have received the proper materials and instructions.

• Involved in the development of study documents including but not limited to training slides, protocols, and reports.

• Actively participated as a member of the study team and contributed to cross functional project team.

• Maintained accurate, professional, and timely sponsor/site correspondence and communication.

• Managed material logistics and acts as contact for clinical trial supplies and other suppliers (vendors) as assigned.

• Ensured overall study progress (screening, enrollment, data entry, etc.) through regular communication with clinical trial sites and contract research organizations.

• Supported the management of trial vendors such as contract research organizations and core labs.

• Assisted in the development of the clinical components of regulatory submissions to competent authorities and notified bodies.

• Participated in the creation of clinical study plans, committee charters and other trial documentation.

• Assisted with the development of the electronic case report forms.

• Participated in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visits and site initiation visits)

• Facilitated the development of clinical trial agreements, study budgets and other relevant documents.

• Participated in site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings.

Clinical Research Associate I, 07/2015 to 07/2017

Icon, Dallas, TX

• Acted as the direct point of contact and coordinator for clinical studies with a focus on managing subject engagement, compliance, recruitment campaigns and scheduling and conducting screening sessions with study participants.

• Answered protocol related questions and relaying questions from sites regarding the protocol.

• Monitored data with a focus on data integrity and patient safety per protocol and in accordance with regulations.

• Planned activities for study monitoring and setting priorities by site.

• Prepared for and conduct site selection, study initiation, interim monitoring, and close-out visits at investigator sites.

• Worked with the team to ensure that visit metrics are maintained as required.

• Ensured that the investigator and site staff are adequately trained on protocol requirements, the investigational product, regulatory and ethical obligations, and AE and SAE reporting.

• Ensured Serious Adverse Events (SAEs) are reported by the site according to the protocol; ensure full SAE reconciliation has been completed at the site level.

• Supported clinical study committee activities and maintains committee documentation.

• Maintained accurate clinical documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, and US regulations.

Clinical Research Coordinator (Oncology), 10/2012 to 07/2015

UT Southwestern, Dallas, TX

• Coordinated all activities for research study agreements, contracts, processes and patients.

• Facilitated and coordinated clinical trial activities including patient recruitment, education and coordination of events to complete the study according to established protocols.

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

• Assisted the principle investigator with development and implementation of patient recruitment plan.

• Ensured that clinical research and related activities are performed in accordance with Federal regulations.

• Ensured that all materials for each clinical trial protocol are available for subject enrollment.

• Developed clinical study budgets based on proposed study protocols and worked in collaboration with finance to monitor study financials.

• Assisted the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal or third party agencies and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures.

• Coordinated and attended sponsor prequalification visits, monitor visits, and study termination visits.

• Notified appropriate institutional officials of external audits by IRB's, Regulatory agencies, CRO's and sponsors.

• Collaborated with PI and institution to respond to any audit findings and implement-approved recommendations.

• Attend investigator meetings requiring travel and reporting pertinent information back to research team members.

Clinical Laboratory Technologist, 01/2011 to 10/2012

Baylor Scott & White Health, Dallas, TX

• Executed corrective actions when test controls were outside specified limits.

• Maintained confidentiality of all patient information to conform to HIPAA, internal and other regulatory standards.

• Utilized expertise in microbiology, chemistry and hematology to help with diagnosis of medical issues.

• Handled specimens according to laboratory protocols to maximize accuracy and precision of results.

• Processed patient specimens according to priority and documented results.

• Managed quality assurance program, including on-site evaluations, internal audits and customer surveys.

• Drove operational improvements which resulted in savings and improved profit margins.

• Resolved conflicts and negotiated mutually beneficial agreements between parties.

• Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.

• Maintained excellent attendance record, consistently arriving to work on time.

Address: : Dallas, TX

Address: : Dallas, TX

Phone: : 469-***-****

Email: : adh85z@r.postjobfree.com

Education

Bachelor of Science, Microbiology, 06/2010

Joseph Ayo Babalola University - Osun State, NG

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