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Clinical Research Coordinator

Company: Midwest Research Group
Location: Saint Charles
Posted on: October 12, 2018

Job Description:

Midwest Research Group, an established research facility and mental health outpatient clinic located in the St. Louis/St. Charles area, is seeking a Clinical Research Coordinator. This position is accountable for completing clinical trial assignments in an accurate and timely manner in accordance with the Standard Operating Procedures (SOP), Core Operating Guidelines (COG), and International Conference on Harmonisation (ICG) Guidelines.

Responsibilities:

-- Ensure the safety of our clinical trial volunteers

-- Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure efficient and compliant clinical operation

-- Provide high level service to sponsor/Clinical Research Organization (CRO) to meet expectations throughout the trial

-- Coordinate study-monitoring visits

-- Assist with regulatory compliance including assisting with preparing IRB materials for approval of protocol amendments, submitting Safety Reports to the IRB, completing IRB continuing review reports, and assisting with drug accountability

-- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct pre-study and initiation visits, liaise with vendors, etc---

-- Screen patients for eligibility on assigned clinical trials in accordance with HIPAA standards

-- Coordinate Research subject consent and entry into appropriate Research studies ensuring that all inclusion and exclusion criteria are met

-- Help ensure that all study documents are complete and that records are retained per federal, state, and institutional standards

-- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

-- Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

-- Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency

-- Help ensure that all study related activities are complete including returning supplies, returning unused stock of study drug/devices, and confirming that all queries are complete.

-- Assist in maintaining regulatory binders

Bachelor's degree is required. CCRC is Recommended.

This is an outpatient schedule that is Monday-Friday. No Call or Weekends

Keywords: Midwest Research Group, Saint Charles , Clinical Research Coordinator, Healthcare , Saint Charles, Missouri

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