Clinical Research Associate
Resume:
Helen B. Jimoh
Dallas, TX
***********@*****.***
PROFILE:
Highly accomplished Clinical Research Associate with a diverse background in various therapeutic areas in phase I-IV clinical trials, ensuring seamless collaboration across cross-functional teams and unwavering compliance with FDA regulations and ICH/GCP standards. Demonstrated success in consistently meeting clinical trial objectives within defined timelines and budgetary parameters and delivering exceptional results that contribute to advancing clinical/medical research and enhancing patient care.
THERAPEUTIC EXPERICENCE
MEDICAL DEVICES/IVDS: MRI Imaging, Catheter, CT Scans, Liquid Biopsy, Ultrasound Devices, Genetic Testing.
HEPATOLOGY: Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease.
ONCOLOGY: Solid Tumors, Hodgkin Lymphoma, Lung Cancer, Breast Cancer, Multiple Myeloma, Liver Cancer.
CARDIOLOGY: Heart Failure, Hypertension.
NEUROLOGY: Alzheimer Disease, Amyotrophic Lateral Sclerosis.
IMMUNOLOGY: Lupus.
INFECTIOUS DISEASES: COVID-19 (Vaccine)
WORK EXPERICENCE
CLINICAL RESEARCH ASSOCIATE/Sr. CRA
IQVIA
September 2020 to Present
Conduct site qualification, initiation, routine monitoring, and close-out visits for clinical trials to ensure compliance with study protocols, Good Clinical Practice (GCP), SOPs, and applicable regulatory requirements.
Conduct on-site and centralized monitoring to protect subject safety, maintain the highest standards of data integrity, and proactively manage risk to ensure inspection readiness.
Monitor investigator sites with a risk-based monitoring approach by applying critical thinking and problem-solving skills to identify site process failures/issues and implement corrective preventive actions to resolve issues and ensure study timelines and objectives are met.
Actively participate in Investigator and other external or internal meetings, audits and regulatory inspections.
Support the development of clinical study documents, e.g. operational plans, templates, study protocol and manuals, monitoring plans, presentations, ICFs, CRF and contracts/site payments.
Facilitate the execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and any amendments.
Ensure data accuracy through SDR, SDV, ICFs, and CRF review as applicable through on-site and remote monitoring activities.
Ensure the safety and well-being of study participants at assigned sites, while also supporting efforts to promote patient recruitment and retention throughout the study.
Provide training and mentorship to junior Clinical Research Associates (CRAs), supporting their integration into study teams and professional development/competency.
Manage study vendors, and develops/maintains strong collaborative relationships with investigators site staffs to facilitate clear communication, and trainings.
Manage investigational products (IP) shipping, and through physical inventory and records review to ensure proper storage, handling, dispensing, and destruction.
Ensure pending identified queries/Action items are being resolve, and that major findings are record promptly and report as necessary.
Provide trial/study status tracking and progress update reports to the Clinical Trial Manager (CTM) as required and prepare or submit monitoring trips reports in alignment to SOPs requirement.
Ensure study systems are up to date and perform regular review of all study systems (e.g., EDC, TMF, CTMS, eTMF, IWRs, etc.) to ensure compliance with the protocol, regulatory and ICH-GCP.
Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
Perform additional study tasks as assigned by CTM (e.g., trip report review, newsletter creation, lead CRA team calls, co-monitoring, and etc.)
IN-HOUSE CLINICAL RESEARCH ASSOCIATE
Poseida Therapeutics
April 2017 to September 2020
Monitored site performance metrics, patient enrollment, and data submission timelines to ensure study objectives were met.
Maintained, reviewed, and updated essential trial documents, ensuring compliance with ICH-GCP, FDA, and local regulatory guidelines.
Assisted with site initiation, IRB/EC submissions, contract negotiations, and obtaining regulatory approvals.
Conducted remote source data verification (SDV), resolved queries, and performed quality checks on electronic case report forms (eCRFs).
Acted as the main liaison for investigative sites, addressing protocol-related inquiries and resolving study-related issues.
Developed materials and conducted training sessions to ensure site personnel understood protocol requirements and compliance standards.
Oversaw adherence to study protocols, SOPs, and regulatory requirements through continuous site monitoring and communication.
Reviewed and assessed site visit reports from field CRAs, identifying trends and escalating concerns when necessary.
Performed virtual site qualification, initiation, routine monitoring, and close-out visits to ensure protocol adherence.
Tracked, reviewed, and escalated safety concerns, protocol deviations, and other compliance issues as needed.
Ensured proper distribution, accountability, and storage of study drugs and clinical materials per protocol requirements.
Assisted in site audits by preparing essential documentation and addressing any compliance deficiencies.
Collaborated with CRAs, project managers, sponsors, and regulatory teams to ensure smooth trial execution.
Generated and distributed reports on trial progress, enrollment metrics, and issue resolution.
Ensured data discrepancies were resolved and assisted in the final reconciliation of study documentation.
Oversaw vendor management, supervising third-party vendors, including central labs, eCOA providers, and imaging vendors, ensuring timely and quality service delivery.
Communicated protocol amendments to sites and ensured all necessary documentation was updated and in place.
Proactively assessed potential risks and implemented mitigation strategies to maintain trial integrity.
Maintained Trial Master File (TMF) compliance and ensured proper organization and filing of essential study documents to support regulatory submissions and inspection readiness.
REGIONAL CLINICAL RESEARCH ASSOCIATE
Miracor Medical
April 2015 to April 2017
Conducted monitoring visits at clinical trial sites within the assigned region ensuring strict adherence to company protocols, SOPs, and regulatory guidelines.
Conducted pre-site selection visits, site initiation visits, interim monitoring visits, and close-out of clinical trial sites across the regional territory, providing comprehensive support to site personnel and ensuring compliance with study protocols.
Oversaw the timely and accurate entry of data into electronic data capture (EDC) systems, ISF and CTMF, and ensure completeness, and consistency.
Reviewed and verified site documentation, including regulatory files, source documents, and trial master files, to guarantee accuracy and completeness throughout the duration of the trials within the regional context.
Collaborated closely with cross-functional teams, such as Data Management, and Regulatory Affairs, to address site-specific challenges and ensure seamless study execution within the regional scope.
Facilitated site qualification and initiation activities within the region, conducting thorough Pre-Study Site Visits to assess site suitability and establish effective working relationships with investigative sites.
Monitored patient safety and data quality across the trials within the region, proactively identifying and resolving issues in collaboration with site staff and internal stakeholders to assure study integrity.
Participated in Investigator Meetings and study training held within the region, providing updates, discussing protocol amendments, and offering guidance on site-specific matters.
Supported site budget negotiation and contract management activities regionally, ensuring alignment with study budgets and timelines while adhering to financial guidelines.
Contributed valuable insights to process improvement initiatives within the Clinical Operations department, sharing best practices and recommendations to enhance efficiency and compliance in clinical trial conduct on a regional scale.
CLINICAL RESEARCH ASSOCIATE II
Novo Tech
September 2012 to April 2015
Performed all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, and conduct of pre-study and initiation visits.
Conducted general on-site monitoring.
Escalated/resolved observed protocol deviations and issues to clinical management expeditiously and followed all issues through to resolution.
Ensured the protection of study participants by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements.
Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by carefully monitoring data for missing or implausible data against established guidelines.
Ensured that required essential documents were complete and in place, according to ICH-GCP and applicable regulations.
Completed Serious Adverse Events (SAE) reporting, processed production of reports, and narratives, and followed up on SAEs.
Independently performed CRF review; query generation and resolution against established data review guidelines on data management systems.
Facilitated effective communication between investigative sites, and the study/project team through written, oral, or electronic contacts.
Responded to company, client, and applicable regulatory requirements, and audits.
Preformed co-monitoring activities with new CRAs and assisted with training of new study teams.
CLINICAL RESEARCH ASSOCIATE I
PPD
June 2010 to September 2012
Developed strong collaborative relationship with investigational site and ensured continuity of relationships through all stages of the trial.
Performed clinical study site management/monitoring activities efficiently in compliance with GCP/ICH requirements, SOPs, local laws and regulations, protocol, clinical Monitoring Plan, and associated documents.
Coordinated and managed assigned tasks in collaboration with the study team to achieve site activation.
Performed remote and on-site monitoring activities using various tools to ensure subject rights, safety, and well-being are protected as well as the reliability and integrity of study data.
Conducted site visits including qualification visits, initiation visits, interim monitoring visits, and close-out visits.
Reviewed and verified study records including source documents, case report forms, informed consent forms, and other systems/materials to ensure data is complete and accurate.
Assessed and monitored investigational product receipt, storage, administration, accountability, and return processes.
Collected, reviewed, and monitored essential regulatory documentation maintained by the site for study start-up, study maintenance, and study close-out.
Preform submission of site essential documents to the TMF following inline quality review and resolved any quality issues related to submitted documents.
Communicated and documented contacts with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, adverse event reporting, site audits/inspections, and overall site performance.
Identified, assessed, and resolved site performance, quality, or compliance problems and escalated as needed per defined escalation pathway to the CTM and/or Clinical Monitoring management.
CLINICAL TRIAL SPECIALIST
PPD
May 2009 to June 2010
Facilitated timely and accurate study-related communication with clinical personnel, including internal and external study teams and investigative site staff.
Prepared and distributed clinical trial correspondence and IND safety letters to project clinicians, while assisting in the development of study-specific manuals, tools, and templates.
Organized, tracked, collected, and maintained audit-ready clinical trial documentation and study progress records in an electronic system.
Managed IRB documentation, IND safety letter distribution, confidentiality disclosure agreements, and other essential clinical trial documents.
Assisted in study and site feasibility assessments and updated study-related information on external websites when applicable.
Ensured the availability of necessary study supplies in alignment with study timelines and coordinated the procurement of clinical trial supplies through external vendors.
Provided support to Clinical Project Managers by drafting meeting agendas and filing them in the CTMS as needed.
CLINICAL RESEARCH COORDINATOR
MD Anderson Cancer Center
January 2008 to May 2009
Contributed to the development and implementation of research and administrative strategies to successfully manage the daily clinical trial activities of multiple complex research studies, from start-up to study closeout, ensuring FDA, ICH-GCP, SOPs, and protocol guidelines are met.
Created, collected, and submitted regulatory documents and ensured that all regulatory documents were filled out accurately in the ISF.
Ensured that subject-matter experts were informed on all aspects of the trial by given copies of, but not limited to, all follow-up letters, and IRB-relevant correspondence.
Ensured staff were delegated and trained appropriately and documented.
Reviewed and comprehended each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
Created source document templates according to the latest version of the protocol and eCRF guidelines and under the guidance of the PI.
Ensured the subject’s safety and confidentiality requirements were protected.
Evaluated potential subjects for participation in clinical trials including phone and in-person pre-screens.
Oversaw and facilitated eligibility screening and study recruitment activities; implemented strategies to increase accrual.
EDUCATION
Texas Southern University-BSC in Respiratory Therapy
Houston Community College-Associate Degree
SKILLS
Proficiency in EDC, CTMS, IWRS, TMF, ICFs, CRFs, and eTMF etc. usage and document review
Scientific concepts and research design
Proficient computer skills; i.e. Word, Excel, SharePoint, and PowerPoint etc.
Ethical participant safety considerations
Data management and query resolution
Ability to multi-task, prioritizes tasks, and plan proactively.
Leadership and management skills
Excellent verbal and written communication and presentation skills.
Problem-solving mindset
General understanding of project goals from an organizational perspective.
Strong organizational skills and attention to detail required.
Managed eligibility screening and recruitment efforts, implementing strategies to enhance participant enrollment and retention.
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