B.S: Public Health2013Temple UniversityPhiladelphia, PAPublic Health
A.S: Biological Sciences2011Montgomery County Community CollegeBlue Bell, PABiological Sciences
Microsoft Office (Word, Excel and PowerPoint )
Great presentation and communication skills
CITI (Collaborative Institutional Training Initiative) Certification
Strong organizational skills
Great attention to details
Fluent in English and Farsi/Persian
Site Start Up and Regulatory Specialist I07/2016 to Current INC ResearchAustin, TX
Forecast submission/approval timelines and ensures they are complied with; if forecasted timelines are not reached provides clear rationale for delays, providing contingency plans to mitigate impact, and escalate the issue as soon as identified.
Monitor basic financial aspects of the project and the number of hours/tasks available per contract; escalate discrepancies in a timely fashion.
Review Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner and update training records accordingly.
Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
Review essential document packages for site activation and may also be involved in essential document collection from site.
Prepare and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
Prepare ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules.
Collaberate with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
Produce site-specific contracts from master template and submits proposed contract and budget for site.
Project Assistant09/2015 to 07/2016 PPDAustin, TX
Project Assistant03/2014 to 09/2015 PPDBlue Bell, PA
Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCP's, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the Client.
Performed PPD investigator file reviews and logging of outstanding issues in project related tracking tools.
Developed and maintains assigned data points within the Siebel clinical database according to the established conventions and streamlining tool for the project within specified timeframes.
Oversaw the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments.
Provided technical support to Project Manager and other team personnel as needed to comply with contract deliverables.
Liaised with clinical project team and investigative sites to coordinate non-clinical/clinical issues on multiple studies.
Assisted with the identification of potential investigators and development/distribution of initial protocol packets.
Facilitated and administrated investigator grant payments.
Participated in internal/client meetings and creating agendas and minutes.
Coordinated team conference calls and completion/distribution of meeting minutes.
Assisted in the assessment and implementation of project specific training activities for new clinical staff.
Senior Intern05/2013 to 08/2013 Temple Health ConnectionPhiladelphia, PA
Completed a400 hour internship at Temple Health Connection which is a nurse-managed, health care facility that provides variety of services to children, teens and adults in low-income area of North Philadelphia.
Created 2 promotional brochures that increased women's participation at free mammogram screening in North Philadelphia by 25%.
Performed blood pressure/ BMI data entry for high school students at Cristo Rey High school and women attending mammogram screenings.
Researched current strategies, lesson plans, and activities on reproductive health for teenagers.
Collaborated with THC Operations Coordinator, Outreach Specialists from the Norris Community, Bridging the Gaps Graduate Interns, Public Health Interns, and Education Works Group Leaders to develop the Norris Kids summer camp schedule and implement health and education based activities among children ages 6-13.
Junior Intern01/2013 to 05/2013 Research and Training Institute of Cancer Support CommunityPhiladelphia, PA
Strengthened in conceptualizion the Cancer Experience Registry and assisted with all aspects of its development, implementation and evaluation.
Completed and submitted IRB applications.
Researched various cancer related articles, summarized and provided notes to management ( e.g., cancer and age related distress, cancer and minority population).
Developed survey questions for multiple myeloma experience registry.
Prepared and coordinated conference calls and took meeting notes.
Prepared tracker for online support groups.
Student Worker06/2012 to 12/2012 Bebashi -Transition to HopePhiladelphia, PA
Worked off campus for nonprofit agency specializing in providing free HIV testing, as well as educational services on sexual health and breast health.
Managed Bebashi's main Facebook page to expand agency's social networking presence.
Performed community outreach to promote Bebashi's services in the community.
Assisted with weekly support groups for HIV positive clients and invited guest speakers.
As part of Foundation Project, researched and provided reports of non-profit organizations which funded human service work similar to that of Bebashi.
agency, basic, blood pressure, brochures, budget, Cancer, clinical study, communication skills, content, continuous improvement, contracts, Client, clients, Data entry, database, Fluent in English, Farsi, fashion, financial, GCP, lesson plans, logging, notes, meetings, Excel, Microsoft Office, PowerPoint, Word, Works, networking, Strong organizational skills, page, personnel, profit, Public Health, quality, Regulatory Affairs, regulatory documents, safety, Siebel, technical support, articles
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
Companies Worked For:
Temple Health Connection
Research and Training Institute of Cancer Support Community
Bebashi -Transition to Hope
Montgomery County Community College
Job Titles Held:
Site Start Up and Regulatory Specialist I
B.S : Public Health 2013 A.S : Biological Sciences 2011
Create a job alert for [job role title] at [location].