Profile of Marie Maher

Marie Maher Sr. CRA
20 years experience 0 projects worked USA
0$ earned
CCRA - Certified Clinical Research Associate

 

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

                                          

 

 

 

 

 

 

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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)

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