Clinical Research Coordinator
Resume:
KENNETH KATAS Costa-Mesa, CA *****
*************@*****.***
PROF ES S I ONA L SU M M A RY
Dependable and accomplished Clinical Research coordinator looking for entering level position into CRC with extensive healthcare experience educating and providing continuity of care to patients. A physician scientist with in- depth experience monitoring and tracking project outcomes. Experienced in collaborating with cross-functional teams to ensure compliance and timely submissions. Strong representational and communication skill-sets, with experience presenting clinical data. PROFESSIONAL EXPERIENCE
VICTORIA CARE MEDICALS GROUP INC. Inglewood, Carlifornia May 2024- Till date QUALITY ASSURANCE COORDINATOR –
● Provide ongoing training for all staff to ensure consistency,high quality conduct and maintenance of high standards in the practice.
● Make sure that all patients in the database attend at least one physical examination onces a year in order for their insurance to still remain active.
● Ensure all patients having chronic diseases have their tests, vaccinations and medical refills up-to-date.
● Maintenance of proper documentation to ensure traceability and accountability.
● Identifying and mitigating potential risk.
DIABETES ASSOCIATES MEDICAL GROUP Orange California, July 2023 till December2023 CLINICAL RESEARCH COORDINATOR – Voluntary
● Ensured that clinical sites are conducting studies in compliance with protocol/clinical investigation plan, SOPs, ICH GCP, and other applicable regulations.
● Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project Project lead.
● Ensured all site-visits are conducted according to country regulations, ICH GCP, and company SOPs.
● Maintain study files and essential regulatory documents in the Trial Master File (TMF)
● Reviewed site essential regulatory documents for accuracy and completeness as required by protocol, sponsor requirements, ICH GCP, and corporate or Sponsor SOPs
● Managed site monitoring activities of clinical trials in compliance regulations, and quality standards
● Performed data entry including query resolutions. Regina Residential Resource Centre Canada September 2018- February 2022 Patient Care Coordinator
• Performed patient data entry and analysis.
• Confidentially managed patient data and clinical records.
• Provided community resources and referrals for continuing care.
• Informed patients and caregivers on procedures to maintain patient health and facilitate recovery goals.
• Ensured that patients are provided with proper medical care, medication compliance and patient-care coordination
• Worked very close with patients, doctors, social workers, pharmacist, and other member of the patient’s care management team
• Conducted in-home visits to patients who are non residents in the care facility.
• Ensured safe care to patients, staff, and visitors; adhered to all procedures.
• Demonstrated safe work practices and attitudes; followed safety rules; worked to prevent unsafe conditions and behaviors; participated in organizational and department safety programs.
• Participated in a collaborative identification and reporting of patient safety issues.
• Other duties as assigned by the Supervisor.
Rapid Medics Biotechnology & Software, PORT HARCOURT, NIGERIA, January 2015 TO August 2018 CLINICAL RESEARCH PHYSICIAN
• Conducted systematic literature reviews and meta analysis
• Prepared manuscripts, abstracts, and poster presentations
• Assisted in research ethics board applications, submission of amendments to support study compliance
• Performed pre-study physical examinations and review lab data and all inclusion/exclusion criteria to ensure volunteers are medically and mentally fit upon entering the study
• Coordinated primary and secondary data collection
• Collaborated with research teams to develop and implement protocols for clinical trials
• Monitored research activities and tracked data for accuracy and completeness
• Managed patient recruitment and follow-up activities
• Prepared and maintained detailed study budgets
• Developed and maintained relationships with external vendors
• Prepared and conducted pre-study, site initiation, closeout, and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols, and project plans per FDA regulations
• Developed status reports, SOP revisions, and document quality control EDUCATION:
CERTIFIED CLINICAL RESEARCH PROFESSIONAL(CCRP), JANUARY 2022- FEBRUARY 2023 Harvard Medical School -Global Clinical Scholastic Research Training (GCSRT), Boston, USA
MEDICINE, JANUARY 2002
University of Benin, Edo state, Nigeria (M.B.B.S) MD 2002
● Knowledge of ICH-GCP guidelines.
● Experience in using CTMS for the entire clinical trial process
● Knowledge of EDC systems and applications (
InForm, iMedidata, and CTMS, )
● Proficient in Microsoft Office Suite (Excel, Word, PowerPoint,
and Outlook)
Therapeutic Experience:
● Endocrinology
● Mental health & Psychiatry
● infectious Disease
● Strong multitasking skills and ability to
prioritize multiple projects
● Great coordination and negotiation skills
and detail- oriented
● Strong analytical and problem-solving skills
● Effective team player and adaptability
● Excellent communication and interpersonal
skills
● Training of Human Subjects in Research
● Solid knowledge with Microsoft Dynamics,
electronic submission requirements
(eCTD), TMF, eTMF,
● Medical Council of Canada (MCC) MINC: 0177-6712
● Medical and Dental council of Nigeria (MDCN) FM 31195 Languages: English (Fluent)
Technical Proficiencies: Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams, Interests: community development- Helping young people discover their potentials KENNETH KATAS
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