Manager Project

Alexis R. Fagan

*** ****** ******, *** ** Boston, MA 02116 617-***-****

******.*****@*****.*** http://www.linkedin.com/pub/alexis-fagan/9/aba/550

Relevant Experience

. Experience with the review of regulatory documents.

. Experience with lab compliance, procedures and protocols.

. Experience in office functions of a lab or research facility.

. Experience with file, records, and database management in a research and

office setting.

. Excellent understanding and daily use of Internet resources and social

media.

. Ability to build good co-worker relationships and contribute in a team

environment.

. Microsoft Outlook, Word, Excel, PowerPoint, Access, Filemaker Pro,

SharePoint, INSPIR, ADEPT, eClinical OS, HTML, Contribute, WordPress,

Sirius, Mac, Microsoft Windows, Insight.

Employment Highlights

Human Research Specialist II 02/2014-

Present

Partners Healthcare - Boston, MA

A not-for-profit health care system that is committed to patient care,

research, teaching, and service to the community locally.

. Analyze and review on-line applications to ensure completeness and

compliance with appropriate federal and state laws, institutional

policies, and Partners guidelines.

. Corresponds with researchers and provide accurate and precise

instructions for the submission completion and requests additional

information and/or clarification from the investigator/study staff as

needed to ensure there is sufficient information to make review

determinations.

. Assigns submissions to the meeting agenda for review.

. Prepare documents and on-line submission materials for member review at

meetings.

. Attend meetings of the convened PHRC and record attendance and votes;

ensure that quorum requirements are met for each review.

. Provides guidance to investigators and clinical research personnel on

policies and procedures. Work with the Director and Administrative Chairs

on educational initiatives.

. Maintain active knowledge on federal, state, local laws and regulations

pertaining to human subject protection through attendance at conferences,

workshops, seminars, or lectures on human subject research.

IRB Assistant Administrator 01/2013-

12/2013

New England Research Institutes - Watertown, MA

Provides clinical and epidemiological research services to both the private

and public sectors

. Analyzed protocols and records to ensure completeness and compliance with

federal regulations and institutional policies and procedures.

. Attended IRB board meeting and prepared meeting agendas and minutes.

. Composed detailed correspondence to investigators and project managers.

. Provided guidance to the NERI research community on IRB policies,

procedures, review requirements, and status of ongoing reviews.

. Pre-screened and assigned expedited and full board reviews to IRB

members.

. Assisted in the development of new IRB policies and forms.

. Served as a voting member of the IRB, reviewing proposals and policies.

Research Administrative Coordinator

New England Research Institutes - Watertown, MA 08/2012-

12/2013

Provides clinical and epidemiological research services to both the private

and public sectors

. Worked directly with the Principal Investigator and Project Manager by

taking responsibility for specialized administrative protocols.

. Maintained project drives, master files and websites, assisted with the

development of presentations.

. Provided administrative support for project meetings (on and off site)

and conference calls, produce and circulate project reports, meeting

minutes and documents to the project team and project sites.

Administrative Assistant (Contract Position)

01/2012-08/2012

Frankel Group - Cambridge, MA

Life Sciences Consulting Firm

. General office management duties for 10 employees.

. Coordinate with New York City office and remote staff.

. Processing of expense reports.

. Transcription of client interviews.

Research Compliance Coordinator 04/2005-

10/2010

Boston University Medical Center - Boston, MA

Department of Research Compliance

. Worked directly with the Executive Director of Research Integrity and

Assurance, and the Director of Technical Committees coordinating research

compliance activities.

. Lead coordinator for a successful AAALAC multi-day site visit and

inspections across 50 sites.

. Responsible for semi-annual inspections of 250 lab and facilities where

live animals are present.

. Coordinate the development of policies and procedures for biohazard and

rDNA protocols.

. Content Manager for two compliance committees; IACUC, IBC.

. Managed communications regarding policies and procedures for research

protocol processes.

. Committee event coordinator for committee meetings, training sessions,

lab inspections and regulatory agencies.

Office Manager 03/2004-04/2005

MarketShare Recovery, Inc. Melville, NY

Early stage startup online marketing

. Responsible for daily office coordination for 7 employees.

. Managed relationships and purchasing with vendors.

. Special projects as assigned.

Education

Master of Arts in Teaching (Elementary Education) 2010

Northeastern University, Boston, MA

Graduate courses taken

Bachelor of Arts in History 2009 -

Graduated

Boston University, Boston, MA

Associates of Arts in Liberal Arts & Science

2001- Graduated

Suffolk County Community College, Selden, NY

Contact this candidate