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Clinical Research Assistant

Location:
Philadelphia, PA
Salary:
Negotiable
Posted:
November 03, 2020

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Resume:

Elizabeth Benner

*** ***** **** **** *******, PA 19382 +1-267-***-**** adhiu9@r.postjobfree.com Education

Temple University, College of Public Health, Philadelphia, PA Bachelor of Science in Public Health, Aug 2017

GPA: 3.5

Employment Experience

ICON, plc– Global Clinical Research Organization North Wales, PA

Global Clinical Trial Assistant Apr 2019-Jul 2019

● Assisted the Clinical Team by providing administrative support amd,made suggestions for improvements related to Clinical Trials in accordance with Good Clinical Practices (GCP), and relevant Standard Operating Procedures (SOP)

● Developed the set-up, management, and maintenance of study related files into an electronic filing system on a timely basis.

● Managed and tracked project activity and updated project management tools on a weekly or timely basis

● Assisted with translation of documents between English and German language to provide language skills to study team

● Participated in Client Conference calls and weekly updates to report project activity and respond to client requests and concerns

MAXIS, LLC– strategic & operational expertise in Clinical Market Development Philadelphia, PA Clinical Research Associate- Home Based East Coast Oct 2017-Jan 2018

● Worked remotely on the smooth execution of medical device clinical trials in U.S., including, clinical site recruitment, clinical site qualification, clinical site initiation, clinical site management

● Assisted in managing CRO data collection/analysis in various electronic document management system

(EDMS), and vendor selection activities for clinical sites

● Participated in Study Protocol adherence and training

● Organized and participated in Investigators’/Sponsor’s Meetings

● Ensured the conduct of all clinical studies and clinical data is in accordance with Good Clinical Practices

(GCP), International Harmonization Guideline (IHG), and appropriate Standard Operating Procedures

(SOP)

● Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution

● Served as primary contact for CROs/vendors, Investigators and study coordinators for study related questions

● Manage patient recruitment strategies to increase patient randomization into the trial University of Pennsylvania- School of Nursing Philadelphia, PA Lead Research Assistant, Department of Biobehavioral Health Science May 2017-Sept 2017

● Supported Principal Investigator with clinical research activities on a behavioral economics-based telehealth interventional study to improve post-MI medication adherence

● Screened, recruited and enrolled patients in multiple hospitals of the University of Pennsylvania health system, becoming the top recruiter in the research study

● Obtained informed consent from participants following IRB guidelines

● Collected and organized data from enrolled participants into an electronic research data capture application as well as administered several different self-care behavior surveys

● Handled participant follow-up call interviews, and responded to participants request and concerns MAXIS Medical– strategic & operational expertise in Clinical Market Development Frankfurt, Germany Junior Project Manager Oct 2014-Jun 2016

● Collaborated with company sponsors and MAXIS team members to coordinate and ensure an efficient and effective execution of clinical studies

● Organized and tracked clinical data for all clinical research studies

● Coordinated with clinical investigators and clinical sites, and maintained consistent follow up data queries to organize and manage protocols. Generated follow up data queries.

● Provided administrative support to finance and administrative team. Coordinated finance activities between the U.S. and Germany

● Supported the translation and production of all regulatory submissions for healthcare products involved in clinical studies

● Processed AE/SAE documentation reporting for the European Union and U.S.

● Performed inventory management of all healthcare products and provided logistical support

● Ensured IRB approvals and contracts met timelines successfully

● Created source documentation and performed document quality control Villa Luna Bilingual School Frankfurt, Germany

English Kindergarten Teacher Jul 2014-Sep 2014

● Created helpful resources and materials for daily English lessons for 26 children

● Effectively applied lesson plans to enhance the children’s English language skills

● Worked closely with parents to keep them informed on their child’s progress in English language class German Au Pair Care Haibach, Germany

Live-In Foreign Au Pair Jul 2012-Jun 2013

● Prepared and coordinated the logistics and planning of daily and monthly activities, including preparing the three children daily for school, as well as picking up and dropping off to school and daily activities

● Completed mandatory German language lessons to become proficient in the language to ensure the most effective communication amongst myself and the children being cared for Volunteer Experiences

Mar 2017- May 2017, Production Development Volunteer, Maternal & Child Health Consortium of Chester County – assisted in creation of agency’s annual report, organized internal documentation of various agency programs and edited program brochures

Skills

German language proficient Microsoft Office proficient, Grant Writing, Data Entry, Project Management, Data analysis, Intercultural communication, negotiation, critical thinking and conflict resolution Certifications

HIPPA Compliance Certification Human Research and Social/Behavioral Research Compliance 2



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