James Maxton
Senior Regional Clinical Research Associate @Indero (formerly Innovaderm)
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WORK HISTORY
Senior Regional Clinical Research Associate @Indero (formerly Innovaderm)
New York, NY, US
Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulationsParticipates in investigators’ meetingsPrepares site visit reports and follow-up letters to the investigatorBuilds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targetsPerforms source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequateEmployee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training
EDUCATION
Long Island University
Pharmacy
Pierce College
Associate of Arts and Sciences (AAS)
Monroe University
B.B.A
Northeastern University
MS
SKILLS
ABOUT JAMES MAXTON
A dedicated, enthusiastic professional with experience and training as a Clinical Research Monitor-Knowledge of (SOP), FDA regulations,(ICH),(cGCP) and (cGMP) guidelines-Skilled in regulatory and compliance to ensure the company\'s success in medical device, biologic, and drug development-Developed regulatory strategies for US, EU, Canada and Japan-Provided regulatory guidance to project teams throughout the following three design control phases for submission of 510(k), IDE, and PMA-Prepared and complied investigator brochure, clinical protocol, and other documentation for submission of IND, NDA, BLA-Experience - 18 years of clinical research experience (including pre-study, initiation, routine monitoring and closeout visits- Knowledge of monitoring procedures- Basic understanding of the clinical trial process- Monitored sites according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
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