Andrea Michelle Steele, Mba Email & Phone Number

Silverado, Ca, Us

West Palm Beach, Florida

Cambridge, Massachusetts

Under minimal supervision, coordinates and performs Documented Trip Report Review and other activities for assigned Sponsor projects using sound working knowledge of Good Clinical Practices (GCP) and applicable regulatory requirements. • Completes all assigned training on time. • Collaborates with Clinical Project Managers (CPM) regarding site and monitor findings on DTRR.• Conducts Documented Trip Report Review (DTRR) to ensure continued quality performance and effectiveness of individual monitors and investigator sites.• Tracks DTRR as required by sponsor and utilizing sponsor tracking systems.• Communicates on a professional level with the study team.• Identifies trends in monitoring and escalates to the study team for discussion and resolution.• Reviews DTRR observations for documented evidence of the following: - Identification and resolution of site or monitor issues in order to maintain the integrity of the study. - Proactive identification, management and escalation of site issues to appropriate parties. - Execution of and adherence to protocols. - Compliance with Adverse Events and Serious Adverse Event reporting. - Execution of and adherence to study monitoring plan and other study procedures. - Compliance with site record keeping. - Regulatory and GCP compliance including continuous IRB IEC review and approval. - Timely access to clinical trial data and supporting documentation. - Data entry and reporting issues are identified and addressed (e.g. missing data, inconsistent data, data errors, potential protocol deviations). - Accurate and reconciled drug accountability. - Site compliance with informed consent process.

Cambridge, Massachusetts

Identify, select, initiate, monitor, and close out appropriate investigational sites for clinical studies in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/MPs applicable regulations and the principles of ICH-GCP.• Recognize exemplify and adhere to ICON's values which center around our commitment to people clients and performance.• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.• Travel( approximately 60%) domestic and/or international.• Familiarity with lCON's SOPsMPs, lCH-GCp and appropriate regulations.• Familiarity with ICON systems.• Maintain timelines. Ensure accuracy and completeness of data entered in to ICON systems.• Familiarity with principles of investigator recruitment.• Assist with coordinating all the necessary activities required to set up and monitor a study.• Ensure storage conditions and acceptable supplies are provided.• Ensure lPs are supplied only to eligible patients.• Ensure lP receipt, use and return are controlled and documented.• Ensure disposition of unused lP comply with regulatory requirement and are inaccordance with the sponsor.• To participate if, requested in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.• Participate in data listing reviews, as applicable.• To be cost effective.• Assist with marketing the company if and when appropriate.• Other duties as assigned.

Greater Boston Area

CRA positions entail a high volume of data abstraction & limited patient contact. Detailed Responsibilities: • Manages multiple genitourinary studies. • Verifies patient eligibility via chart abstraction and clinical analysis of case data. • Collects and interprets data necessary for enrollment; registers patients. • Monitors and evaluates protocol compliance.• Manages data collection via chart abstraction and submits data in timely fashion. • Monitors and reports adverse events as required by institutional/federal regulations. • Administers Quality of Life and pain assessment evaluations to patients as needed. • Coordinates and procures investigational drug supplies. • Resolves data discrepancies as requested by Sponsors. • Coordinates and processes tissue samples as required by protocol. • Prepares submission of protocol revisions and safety reports to the IRB. • Prepares annual progress reports for IRB renewal of ongoing studies. • Organizes and attends on- and off-site Investigator meetings. • Organizes monitoring visits as requested by Sponsors and makes data corrections as required by Monitor.

Portland, Oregon

The primary purpose for this position was to support large federally funded studies relating to women and children’s health, quality of care, and patient safety. This position included assisting the PI's, project coordinator, and investigators in the preparation, maintenance, organization, tracking and reporting of research projects; data entry into database or web based applications; abstracting basic data from medical records; assisting in preparation, maintenance, and monitoring of research, grant, report, and regulatory documents; obtaining signatures; carrying out of day-to-day study activities and procedures; checking the accuracy of the data collected and ensured compliance with protocol objectives; and assisted the PI with other projects and duties as needed.

Portland, Oregon

As a Study Coordinator for OHSU's Center for Hematologic Malignancies (CHM), I was responsible for the preparation, submission, and management of clinical trials in oncology, including - completing all OHSU IRB required regulatory documentation; creation of study calendars and flow charts; verification of patient eligibility; development of data collection instruments and consent forms; data entry; assurance of appropriate conduct of protocol to NCI and FDA guidelines; preparation of protocol abstracts; and maintenance of study patient records and assisting my manager in verifying appropriate clinical trial billing. I also assisted in and participated in the continuing education of physicians, residents, interns, nurses and other related personnel with regards to knowledge of clinical trials and activities.

Portland, Oregon

OHSU is a Research institution that collaborates with the Portland VA Medical Center to form the Portland Alcohol Research Center. Managed and organized ongoing research projects examining effects of chronic ethanol administration, learning, memory and withdrawal from alcohol. Evaluated, compiled, and analyzed data for ongoing studies on Alcoholism. Set up the operant chambers, including circuitry, for new SIP design. Successfully adapted Schedule-Induced Polydipsia (SIP) from monkeys to mice in an operant conditioning model at OHSU currently in process, studying the relationship between food and alcohol. Requested by Supervisor to assist on the adaptation.

Portland, Oregon

Sisters creates community-driven solutions to the calamities of homelessness and poverty.The phrase "persistent poverty" implies that poverty persists despite society's best efforts to end it. The truth is the opposite, that our current economic and political system produces poverty, again and again, despite the best efforts of individuals and families to escape it.Mission:Sisters Of The Road exists to build authentic relationships and alleviate the hunger of isolation in an atmosphere of nonviolence and gentle personalism that nurtures the whole individual, while seeking systemic solutions that reach the roots of homelessness and poverty to end them forever.Our Philosophy:Nonviolence, gentle personalism and the community organizing model are the ideals which inform all actions and decisions at Sisters Of The Road. It is understood that all individuals are equally worthy, that no one has a monopoly on the truth, and that we have much to learn from one another. There is a consistent refusal to participate in or condone any act of violence, any act of harm or humiliation, including sexism or racism. All violence is interrupted and attempts are made to resolve conflicts with respect. Sisters recognizes, nurtures and celebrates community by building relationships through its programs, special events and outreach.A Radical Organization:Many of you may have heard about Sisters Of The Road, but what is it that is so special that is happening down there? Sisters is innately about building community. Yes, we serve hot, nutritious food and offer job training opportunities for people experiencing homelessness. But Sisters is also about radical, get to the root change – change of heart and understanding that we believe leads to individual and community efforts and solutions to end the calamities of homelessness and poverty. At least helps us to end our acceptance of these calamities as a given in our community.Please Donate today!

Portland, Oregon

BrainGames is an annual event each September targeting young at heart professionals who are interested in giving back to their community while competing in a fun team challenge and learning about Sarurday Academy. Teams consist of 6 members and compete in a series of academic challenges connected to Saturday Academy offerings: from science and technology to acting and the humanities, teams will be challenged to respond to a number of challenges in a wide range of forms...dancing, constructing, calculating, singing, equating their way to the best answer!

Portland, Oregon

Not-for-profit network of hospitals, health plans, physicians, clinics, home health services, and affiliated health services. The Oregon Health Study is a grant-funded research study through the CORE (Center for Outcomes Research and Education) Department studying the effects of the lottery drawing on Oregonian's health; Collect health-care outcome data from study participants. Recruit, schedule and interview study participants who were at one time on the reservation list for the Oregon Health Plan, including those who both did and did not receive health care services. Developed and executed innovative recruiting techniques by using social networking sites including Facebook, MySpace, LinkedIn, Twitter and YouTube to track study participants. Influential in team reaching its incentives, including last minute home interviews and working additional clinic shifts in order to meet with additional study participants.

Portland, Oregon

Portland VA Medical Center is a research institution that collaborates with OHSU to form the Portland Alcohol Research Center. Managed ongoing projects examining effects of chronic ethanol administration, learning, memory and withdrawal from alcohol. Evaluated, compiled, and analyzed data for ongoing studies on Alcoholism. Set up the operant chambers and ran a breeding colony for a short while, requiring database management.Collaborated in the writing of manuscripts and editing of grants with articles published in hi-echelon scientific/medical/research journals (see below for examples; inclusive list provided upon request.)Analyzed and presented research findings at the 29th Annual Scientific Meeting of the Research Society on Alcoholism; in which thousands of research professionals attend from global locations. Findings were later published in The Psychopharmacology Journal.Mentor to Neuroscience PhD students; provided training on day-to-day operations, including project timetables, developing protocols, collection and analysis of data.

Held Responsibility for patient scheduling, fee collection, and administrative duties.Administered introductory tests for patient's prior to visit with Doctor, increasing productivity by 20%.Developed and executed presentations at trade shows promoting the benefits of Chiropractic care; new patient count grew by 100 per year.

Mba, Health Care Administration

• Cross-Cultural Management Term Project—Gordon Pacific Supply, LLC. • Health Care Finance—Reorganization of Medical Practice in the US. •.

Bs, Psychology, Biology, Business

Activities and Societies: Psi Chi. Worked closely with Dr. Steinberg on her 2001-2002 project utilizing questionnaires to evaluate.

Education record

High School Diploma