RITA OBAIYA OTOWO

• ad37td@r.postjobfree.com • 301-***-****)

PROFILE SUMMARY

A Clinical Research Associate with a solid academic and professional foundation, extensive expertise in overseeing clinical research across various therapeutic areas and phases. Possesses comprehensive knowledge in clinical trial design, execution, analysis, regulatory guidelines, and SOPs. Proficient in utilizing industry-specific systems such as EDC, eTMF, CTMS, and IWRS. Demonstrates exceptional time management capabilities, coupled with adept documentation and reporting skills. Possesses a profound understanding of ICH-GCP guidelines, FDA regulations, and ALCOA principles. Strong communication and ICT skills, combined with a meticulous eye for detail.

THERAPEUTIC EXPERIENCE

oMEDICAL DEVICES/IVD: Cardiovascular Devices, Ophthalmic Devices, Blood Glucose Monitors.

oONCOLOGY: Solid Tumors, Lymphoma, Leukaemia, Breast Cancer, Gastrointestinal Cancer, Lung Cancer, Multiple Myeloma.

oNEUROLOGY: Alzheimer's Disease, Parkinson’s Disease.

oRARE DISEASES: Cystic Fibrosis, Crohn’s Disease.

oENDOCRINOLOGY: Metabolic Disorders, Diabetes.

oCARDIOVASCULAR: Cardiovascular Diseases.

oIMMUNOLOGY: Lupus, Rheumatoid Arthritis.

oDEMERTOLOGY: Dermatitis.

EMPLOYMENT HISTORY

ABBVIE CLINICAL RESEARCH ASSOCIATE AUGUST 2022- PRESENT

oServes as the primary point of contact for investigative sites, manages query resolution, supports Trial Master File activities, participates in Investigators’ Meetings, and completes other project tasks in accordance with study timelines and budget.

oPerforms remote and onsite visits and participates in the investigator recruitment process.

oPerforms study site selection, initiation, monitoring, and study close-out activities.

oReviews with the site personnel, the protocol, study procedures, regulatory issues, and provides training on completion of the eCRF, data entry into the EDC system, and verifies site computer system.

oAssists in resolving any issues to ensure compliance with site file audits.

oEnsures adherence to Good Clinical Practices, Data integrity, and compliance with all study procedures through on-site and remote monitoring visits.

oEnsures data accuracy through SDR, SDV and CRF review as required.

oPerforms validation of source documentation as required and prepares monitoring reports and letters per the timelines required.

oPerforms investigational product inventory, documents accountability, stability, and storage conditions of clinical trial materials as required, and ensures the return of unused materials to designated location or verifies destruction as required.

oReviews protocols, eCRFs, study manuals, and other related documents, as requested by Clinical Trial Manager.

oEnsures all study deliverables are completed per study timelines.

oAssists with management of clinical trial vendors.

oEnsures CTMS and other study systems are updated and properly managed as required.

oEnsures the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety, protocol, and customer requirements.

oIdentifies and escalates potential risks and possible retraining opportunities for investigative sites.

oEnsured completeness and accuracy of reports, as well as site visit letters and other forms of documentation and compliance with required submission timelines.

UC SAN DIEGO HEALTH CLINICAL RESEARCH ASSOCIATE I JULY 2021– AUGUST 2022

oPerformed clinical research site management activities, including site qualification (selection), initiation, routine monitoring, and closeout visits for assigned sites.

oEnsured that the investigator is enrolling only eligible subjects.

o Ensured compliance with the subject Informed Consent process and performed quality assurance activities to ensure procured required clinical data from sites has been completed per protocol and is accurate through routine monitoring of the electronic data capture (EDC) system and patient medical records.

oEnsured that sites maintained sufficient investigational product to properly conduct trials.

oManaged IP accountability, inventory, and distribution, assisted in resolving IP temperature excursions, and assisted sites with corrective and preventative actions (CAPA).

oAssisted in the development, review, and updating of study-related training materials and documents including site initiation training slides, informed consent form templates, and procedure manuals required for the conduct of clinical trials.

oEnsured studies are carried out according to the monitoring plan, study protocol, SOPs ICH/GCP guidelines, Code of Federal Regulations, and study-specific plans and procedures.

oManaged distribution, collection, and tracking of regulatory documentation.

oWorked with clinical sites to resolve any site-related issues timely and effectively.

oConducted on-site study-specific training, site facilities inspection, and collection of regulatory documents.

oRe-trained site staff remotely on study-specific tasks and procedures.

oAssisted in preparation, negotiation, and management of study budgets, performed reviews of the sites, and vendor invoice.

EDUCATION

oMaster’s Degree: Public health: Southern New Hampshire University (in progress)

oBachelor’s Degree: Microbiology: University of Ibadan

oPMP certified

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