Proficient clinical research Professional
Monitoring Expertise Detail Oriented Accountable Patient-Focused
Experienced and Dependable Clinical Research Associate with proficiency in all areas of clinical research, source data verification, report writing, and a team player. Enthusiastic and able to enhance client satisfaction in the best way possible. Understand the importance of following protocols/guidelines to achieve Patient Safety and Tolerability at the end of every study.
ESSENTIAL Skills and Competencies
Efficient Data and Risk Management Skills
Creative Sourcing and Recruitment Techniques
Ability to travel without restrictions
Phase I - III clinical trials experience
Experience with EDC and CTMS platforms
Site Staff Relationship Management
Microsoft Office such as Word, Excel, Outlook
Clinical Research Associate II-Home-Based Atlanta, GA
PPD Pharmaceutical Oct2017-Present
Acts as the primary point of contact with assigned investigative sites, that includes site communication and development, execution of site-specific plans, patient recruitment and retention activities.
Coordinates, schedules, and conducts interim monitoring visits to ensure compliance to the clinical protocol, regulations, and timely receipt of data including source documents.
Performs data management with data review, query generation and resolution, and adverse event
review, narrative generation, and reporting.
Participates in the site qualification, activation and study initiation process, including review and
approval of site activation documentation.
Conducts site initiation visits and provides ongoing training to site personnel as needed.
Establishes and maintains regular contact with investigative site personnel to ensure clinical protocol compliance, and collection of appropriate patient data.
Manages the development and implementation of site corrective actions as needed to address any
Assists sites with SMO, Audit Preparedness and Reviewing Monitoring Reports.
Coordinates, schedules, and conducts site close-out visits at investigational sites, including educating
sites regarding record retention requirements.
Clinical Research Associate I-Home-Based Atlanta, GA
PPD Pharmaceutical Jun2015-Oct2017
Tracks and reports the progress of clinical studies, i.e., subject screening and enrolment,
data collection, and adverse event documentation.
Assists with the development and management of study-related documents including clinical protocols, case reports forms, monitoring plans, study manuals, and other study-related tools.
Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
Conducts clinical site and data monitoring and completes monitoring visit reports
Supports study supply, bio-specimen delivery, and bio-specimen testing logistics
Evaluates clinical data and coordinates data query resolutions
Supports internal departmental quality compliance
Prepares progress reports and performance metrics
Ascertained and recommended appropriate follow-up responses to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training.
Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions per the project communication, monitoring, and/or training plans.
Clinical Research Coordinator Atlanta, GA
Emory University Teaching Hospital Mar2014-May2015
Handled administrative activities generally associated with the conduct of clinical trials and helped with on-boarding process of new hires.
Managed research project databases, develops flow sheets and other study related documents, and completes source
documents/case report forms.
Interfaced with research participants, determined eligibility and consent study participants according to protocol.
Approved orders for supplies and Completion of Patient Source and CRF.
Assisted in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires
Supervised collection of study specimens and processing in accordance with study protocols.
Established case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed
Ensured compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors.
Prepared regulatory submissions of key documents.
Rare Disease – Pulmonary Arterial Hypertension (PAH) and Cystic Fibrosis
Oncology – Leukemia/AML, Solid Tumour, and Breast Cancer
Women’s Health – Ovarian Cysts and Endometriosis
Cardiology – Stroke, Heart Failure, Hypertension
CNS- Bipolar Disorder and Parkinson Disease
Ambros Alli University, Edo State, Nigeria
Bachelor of Science, Biochemistry(B.Sc)
Good Clinical Practice Certification (21 CFR Part 11 Training Whitehall)
Dangerous Goods Training/ IATA Training