cell phone: 708-***-****
CLINCAL RESEARCH ASSOCIATE
3.0 years of Regional home-based monitoring experience
5.5 years of Clinical Research experience
Oncology (3 sites)
Cardiovascular (9 sites)
•Diabetes Mellitus Phase III
•Arrhythmia Phase III
•Extremely proficient with computer programs:
•Microsoft (Excel, Outlook, Word, and Powerpoint)
•EDC (Oracle, Marvin)
•Complete knowledge of SOPs, GCP, ICH and FDA guidelines including basic understanding of regulatory requirements
•Ability to design, implement, and ensure following of trial protocols
•Excellent knowledge of complete aspects of the clinical trials
•Strong communication skills
Jackson State University: Jackson, MS
Bachelors of Science
THERAPEUTIC AREAS OF EXPERTISE
•Arrhythmia Phase III
•Diabetes Mellitus Phase III
•Peripheral Artery Disease
•Breast Phase I and III
•Pulmonary Embolism Phase II
•Acute Bronchitis Phase II
Abbvie October 2019 - present
Abbott Park Illinois
Clinical Documentation Analyst, (Clinical Operation Center)
Functional Area Subject Matter Expert for system-related activities, to include but not limited to: - provide answers to stakeholder system-related questions - consider and take action on stakeholder requests and suggestions - review queries/issues, identify trends, investigate potential root cause(s) and execute on solutions - lead and/or participate in stakeholder SME and cross-functional meetings - business level maintenance of eTMF system
Supports system integrations with VAULT eTMF system.
Contributes to strategic training plan; creates material and conducts training across TMF stakeholders
Creates, runs and interprets reports and dashboards within eTMF; produces eTMF metrics.
Conducts quality control checks across the eTMF system.
Provides audit and inspection preparation support for eTMFs.
Provide input and/or recommendations to SOPs, Work Instructions and Job Aides related to eTMF processes.
Contribute to (may lead) functional area continuous improvement projects and/or work streams.
Works closely with Clinical Documentation Center (CDC) colleagues, artifact owners (i.e., functional areas) and IT (BSOS).
Complies with GCP, client SOPs and functional area processes
Clinical Research Associate II March 2018 – June 2019
•Coordinates day-to-day activities of several small scale project(s) or phases of one or more larger projects. Collects project data through interviews, chart review or other methods. May collect, secure and assist with biospecimen management.
May assist in development of study tools (e.g. tracking forms, questionnaires, chart review forms, etc.).
•Assists with and/ or oversees assigned study activities (e.g. data collection and validation, recruitment activities, pilot studies, focus groups, etc).
•Drafts project progress reports collaboratively.
•May participate in the training of new team members and/or clinical staff. If assigned to clinical trial, may work with Sponsors/ monitors at clinical sites.
•Adheres to compliance and privacy/ confidentiality requirements and standards. Adheres to GCP and compliance regulations for clinical trials.
•Assists with and/ or oversees quality assurance of study activities; ensures quality data.
•Submit and receive clinical documentation through eTMF using systems such as (trial interactive, rave, Medidata etc.) and house documentation through vendors such as iron mountain etc.
•Work closely wit DM (data management) on training site staff on the use of EDC and eTMF systems.
•Acquires and maintains knowledge of EDC systems and databases. Answering and writing queries, checking off on data points and assessments and finalizing and cleaning data.
•Identifies, recommends and implements solutions to study issues.
•May interface with IRB and/ or draft portions of IRB protocols, amendments, continuing reviews, etc.
•May supervise the day-to-day activities of project staff (ex. assign work and evaluate performance, etc).
•assist with staff hiring and training.
•contribute to portions of study presentations.
•Track expenses and monitor budget. May recommend budget actions/ decisions.
•provide information and oversight for invoices.
•Reviews scientific literature and synthesizes and summarizes information.
Durham, NC February 2017 – February 2018
Clinical Research Associate II
•Perform routine and complex on-site and in-house site assessments such as, initiation, routine monitoring, and study closeout visits for clinical trial studies
•Collect documents, update, and report study information according to project-specific scope of work and timelines
•Oversee and review routine and complex site activities, of trial-specific monitoring plan to assess study progress and protocol, regulatory, and SOP compliance.
•Perform monitor activities source document verification, informed consent process and human subject protection, data integrity, drug accountability and compliance, and review of investigator and regulatory files
•Provide study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations
•Perform trial supervisory activities as directed by trial manager with approval of line manager
•manage and review routine and complex data systems, including case report form (CFR) completion and submission, data query resolution, and overall data integrity according to established practices
•Review patient data and source documents. Appropriately report safety concerns, protocol deviations or unexpected data trends
•Provide timely notification to appropriate study contacts of site status and trial related needs.
•Act as the point person for routine and complex trial-specific activities, working collaboratively with trial team members
•Routinely communicate with internal partners as needed for trial activities
•Develop and implement site training plans and materials, including site initiation activities, agendas, slides, and study tools
PPD September 2013 – December 2016 Wilmington, NC
Clinical Research Associate I/II (Remote)
•Conduct site pre-study, initiation, routine monitoring, and study closeout visits.
•Monitor, track, and manage all study related tasks at study sites ensuring compliance with GCP, ICH, applicable regulations and company SOPs.
•Collect, review, track, and ensure appropriate completion of site-specific study/essential documents.
•Performs ongoing reconciliation of the Trial Master File (TMF) content to site files.
•Primary contact for study site personnel.
•Provide training to site personnel.
•Track and report progress of study sites.
•Responsible for quality data from study sites.
•Ensures appropriate source documentation, training, and accurate transcription of data into the study Case Report Form (CRF) as evidenced by minimal data query rates.
•Ensures timely reconciliation of data queries and implementation of process improvement/corrective action when needed.
•Participate in team meetings
•Coordinate, assemble, and ship study related supplies as needed.
•Assist with creation and review of study tools/documents.
Jackson Memorial Hospital June 2011 - September 2013 Jackson, MS.
•Recruited subjects for Therapeutic Protocols from Phase I thru Phase III
•Conducted protocol specific training and development activities.
•Developed approaches for tracking study subjects, study status, and tools to track monitoring activity accordingly.
•Worked with CRAs, study coordinators, and investigators to ensure protocol and ICH-GCP compliance.
•Assisted and coordinated efforts with Query Management/CRAs to review and resolve data queries
•Acted as central contact for all clinical monitoring activities.
•Ensured communication flows within the Clinical Monitoring project team across all locations, and with other departments as appropriate.
•Developed subject visit compliance strategies.
•Worked with study team to resolve clinical and/or protocol issues.
•Assisted with the development of monitoring guidelines, CRF instructions, training materials, and other monitoring tools.
Jackson State University Aug 2009 – June 2011 Jackson, MS.
•Under supervision, conducted and evaluated experiments and assays
•Followed experimental protocols (which included animal handing, tissue culture, etc.)
•Performed calculations involving molarity, % solutions, and serial dilutions
•Followed University safety protocols
•Read and followed all equipment manuals
•Assisted in modifications as directed
•Prepared preliminary research progress reports
•Summarized test results appropriately