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Clinical Research Associate Job

Date: Nov 17, 2017

Location: Benito Juárez, MX

Company: MSD

Requisition ID: CLI006322

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare


 


Main Responsibilities:




  • 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, MSd 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, dependingon study/site complexity.

  • Discusses the need for escalation of site performance issues with CRM or TRM, and supports audit/inspection activities as needed.
Qualifications

Education: B.A./B.S. Preferred with strong emphasis in science.

Experience: 4-8 years experience: 2-5 years clinical research experience preferred 2 yrs of which should be site management experience.

English: Fluency Oral and written


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Clinical Research Monitor
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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