by Brunel International in [, , Afghanistan ][Bridgewater, New Jersey , United States ][Madison, Kansas , United States ][Yorkshire, New York , United States ]
Experience: 3 to 10 yrs. | Salary: INR - Lakh P.A | Opening(s): 4 | Posted on: 04-Feb-2016
As a Regional Clinical Research associate you are responsibilities include: •Acts as primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies. •Communicates with sites on issues related to protocol conduct, enrollment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments. •Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP, Merck global standards, local laws and regulations, including but not limited to review of informed consent, AE/SAEs, Health Authority documentation, and IMP supplies. •Performs source document verification of subject data and query resolution. •Provides input to Site Selection utilizing site evaluation and validation processes. •Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. •Manages a full complement of sites with multiple protocols, depending on study/site complexity. Discusses the need for escalation of site performance issues with CRM or TRM, and supports audit/inspection activities as needed
Salary : INR - Lakhs P.A.
Industry : Clinical Research ,
Functional Area : Clinical Research,Clinical Data Management ,
Role : Clinical Research Associate
Keyskills: monitor, clinical research associate, cra
Education:
Course:
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