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Clinical Research Data

Location:
Kennesaw, GA
Posted:
October 16, 2019

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Resume:

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

Excellent Communication

Site Staff Relationship Management

Microsoft Office such as Word, Excel, Outlook

Professional Experience

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

compliance issues.

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.

Therapeutic Experiences

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

Education

Ambros Alli University, Edo State, Nigeria

Bachelor of Science, Biochemistry(B.Sc)

Certification

Good Clinical Practice Certification (21 CFR Part 11 Training Whitehall)

Dangerous Goods Training/ IATA Training



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