Abiola Shittu

646-***-****

adjf92@r.postjobfree.com

Staten Island, NY

Professional Summary

Quality-conscious Clinical Research Associate with 3+ years' experience in performing site qualification, site initiation, interim monitoring and study close-visits. Diligent in performing studies aligned with Good Clinical Practices, study specific requirements and clinical monitoring plans.

THERAPEUTIC EXPERIENCE

Endocrine

Respiratory

CNS

Infectious Disease

EDUCATION HIGHLIGHTS AND CREDENTIALS

Ladoke Akintola University of Technology: Master’s In business administration

PROFESSIONAL EXPERIENCE

Clinical Research Associate Nov 2017 – Present

PRA Health Sciences, Blue Bell, PA, UNITED STATES

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites. May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.

•Participated in the management of assigned clinical trials.

•Responsibilities included, abstracting, assembling and organizing research data while monitoring the clinical course of patients entered onto research protocol

•Conducted Pre-study, Initiation, interim and Closeout Visits

•Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines

•Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, and project Standard Operating Procedures (SOPs), and sponsor requirements.

•Maintains travel schedule at approximately 60-65%

•Communicated common site trends to lead CRA and other project team members

•Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtained direction from more senior clinical operations staff

•Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures

•Provided regular clinical status information to team members and project management

•Monitored clinical trials to ensure sponsor and investigator obligations have been met and are compliant with applicable local regulatory requirements and ICH guidelines

•Visited sites to assess the qualification of potential investigative sites, initiated studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies

•Managed relationship with PI and study staff to ensure maximum productivity

Study Coordinator Jan. 2016 – Nov 2017

Fadmo Health Care Agency

Supported enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.

Reviewed the study design and inclusion/exclusion criteria with physicians and patients

Ensured the protection of study patients by verifying informed consent procedures and adhering to protocol requirements

Collected, completed, and entered data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines

Ensured the integrity of the data submitted on case report forms or other data collection tools by careful source document review and monitoring data for missing or implausible data

Create study specific tools for source documentation when not provided by sponsor

Generated and track drug shipments, lab kits, and other supplies

Was responsible for accurate and complete documentation of protocol requirements according to site work instructions and standard operating procedures (SOPs)

Tracked and report adverse events, serious adverse events, protocol waivers, and deviations

Maintained accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications

Coordinated regular site research meetings

SOFTWARE COMPETENCIES

Proficient in Microsoft Office applications

Word,

Excel,

Outlook

PowerPoint

Proficient in the use of

EDC (Medidata RAVE, Inform)

CTMS (Veeva)

IVRS (Almac)

Contact this candidate