Marie Maher, RN, B.P.S.
Senior Clinical Research Associate
5438 Lake Vista Dr.
Durham, NC 27712
lexmar@mindspring.com (919) 383-2662
PROFESSIONAL SUMMARY
Experience in the clinical research field (Quality Assurance Associate, Site Auditor, and Clinical Research Associate) in addition to executive health care administration experience.
· Expertise in monitoring and managing challenging clinical investigative sites according to the Federal Code of Regulations, GCP guidelines, and applicable company policies.
· Proficient in all aspects of monitoring, regulatory reconciliation, drug accountability.
· Ability to train, mentor and assess CRAs.
· Phase 2 – IV pharmaceutical studies and device study experience
Therapeutic areas: renal, CNS, cardiology, hypertension, COPD, ortho, pediatric ADHD, cosmetic, GI, RA, HIV, virology, and womens’ health. Private instructor – GCP, regulations, ICF, monitoring, report writing and safety.
Semi retirement Nov 2013
PROFESSIONAL EXPERIENCE
Jan 2018-present Private teaching – research personnel interested in monitoring. No charge
Sep 2016-Mar 2017
Sep 2015-Jul 2016 Glaser Research Group – assigned to Ampio Pharmaceutical Co & PMI Int’l
. Assessed administration of WOMAC questionnaire OA of the knee – osteo arthritis. Monitor R/A study for compliance – monitoring and close out visits
Jan 2014-May 2015 Private teaching – research research personnel interested in monitoring.
Jul/2012 –Oct/2013 Clinipace Worldwide (Formerly Paragon Biomedical, Inc.)
Regional Senior Clinical Research Associate
· Trained, mentored and assessed monitors.
· Demonstrated proficiency in all aspects of monitoring, co-monitoring and mentoring.
· Managed clinical investigative sites (renal-hi risk surgery).
· Performed trial coordination and activities (e.g., unanticipated adverse event management, data verification) as required
· Facilitated the distribution of supplies, forms, equipment, and study devices to sites.
· Responsible for tracking and site/sponsor communications.
· Conducted monitor assessments: documented and communicated any growth and development needs to the Project Manager/Director
L
exmar@mindspring.com (919) 383-2662
Nov/2011 – Jul/2012 Research Pharmaceutical Services
Regional Senior Site Manager assigned to Johnson & Johnson
· Compiled regulatory documents (e.g., IRB approval, consent form, lab certifications).
· Completed eCRF review and resolved data management queries.
· Ensured compliance with regulatory requirements for CTM accountability and study files.
· Communicated all site visit findings and updates in monitoring visit reports.
Managed clinical investigative site participating in Hep C, & HIV
Sep/2009 – Nov/2011 Worldwide Clinical Trials (Formerly CSMG)
Regional Senior Clinical Research Associate
· Therapeutic area: CNS – Bipolar I & II
· Conducted Pre-Qualifying, Site Initiation, Interim, and Close Out Monitoring Visits for Phase III study.
· Developed monitoring expectations for IM.
· Performed new employee Monitoring Performance Assessments.
· Mentored and Trained junior CRAs.
Apr/2004 – May/2009 Averion, Inc.
Clinical Research Associate
· Therapeutic areas: renal, cosmetic, ortho, AHF, and CNS
· Conducted Pre-Qualifying, Site Initiation, Interim and Close Out Visits for Phase II and Phase III studies.
· Promoted to Sr. CRA 2006
· Two sites audited by FDA: no recommendations or 483s issued Performed Quality Assessments.
· Mentored and Trained new CRAs on GCP, report writing, and sponsor communication.
· Developed Site Transfer Guidelines and forms.
Nov/2003 – Mar/2004 PPD Medical Communications
Consultant
· Therapeutic areas: ED, diabetes, human growth hormone
· Identified AE’s and Product Complaints.
· Documented call information according to protocol.
Marie Maher, RN, B.P.S.
lexmar@mindspring.com (919) 383-2662
EDUCATION, LICENSURE, AND CERTIFICATION
State University of Technology, Utica, NY B.P.S., Health Services Management
Duchess Community College, Poughkeepsie, NY A.A.S., Nursing
GCP Training Updated September 2015 – CITI Program
NC Licensed Registered Nurse (Inactive)
NYS Licensed Nursing Home Administrator (Inactive)
ACRP Certified CCRA (Inactive)
We will review the reports from both freelancer and employer to give the best decision. It will take 3-5 business days for reviewing after receiving two reports.