Rita Adeoti
Katy,TX
Summary
Creative Clinical Research Associate with extensive project experience from drug and device concept to development. Talents include in-depth knowledge of ICH guidelines, SAE reporting, Integral team player with excellent communication skills, experienced in complying with study protocols, standard operating procedures and good clinical practices.
Overview
7
7
years of professional experience
Work History
Clinical Research Associate
Curebase Clinical Research Services
San Francisco, CA
12.2020 - Current
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Maintained strict confidentiality to keep personal information and data collected private
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Assists with web based and face to face trainings to ensure that investigators and site staff- are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical.
Clinical Research Coordinator
West Oaks Hospital
Houston, TX
02.2019 - 12.2020
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Coordinates all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Conducted informed consent presentations and maintained documentation.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance with study sponsor, primary investigator, and regulatory agency specifications.
- Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects
- Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports
Clinical Site & Start -up Associate
West Oaks Hospital
Houston, TX
01.2017 - 11.2019
- Assist with Patients Vitals Signs and document .
- Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials in line with established targets and including communication of updates
- Ensures proactive risk identification and mitigation planning for assigned clinical trial sites
- Drives and tracks site activation and start-up activities with clinical trial sites to support trial start-up strategies
- Provides system and device expertise to train and support clinical trial sites
- Ensures ongoing collection and review of relevant documentation e.g., related to protocol amendments, site staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance with relevant regulatory requirements and ICH and GCP guidelines
- Provides support to prepare for and follow-up on audits and inspections
- Contributes actively to trial Core team and other relevant teams.
Education
Bachelor of Science - Economics
Lagos State University
Lagos08.2012
Skills
- Extensive knowledge of clinical trial
- Excellent oral and written communication skills
- Sound analytical skills and detail oriented
- Great Interpersonal skills
- Immense multi-tasking capability
- Knowledge in data recording and management
- Extensive knowledge of ICH GCPs and FDA regulations
Timeline
Clinical Research Associate
Curebase Clinical Research Services
12.2020 - Current
Clinical Research Coordinator
West Oaks Hospital
02.2019 - 12.2020
Clinical Site & Start -up Associate
West Oaks Hospital
01.2017 - 11.2019
Bachelor of Science - Economics
Lagos State University
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