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Clinical Research Associate (CRA)

Brain Sentinel


Location:
San Antonio, Texas
Date:
11/14/2017
2017-11-142017-12-14
Job Type:
Employee
Categories:
  • Clinical Operations
Brain Sentinel
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  • Research Salary

Job Details

Job Summary

The CRA (clinical research associate; also commonly known as a monitor) is responsible for site management and compliance monitoring of assigned sites for a clinical trial on behalf of a sponsor. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Standard Operating Procedures (SOP).

Responsibilities and Duties

  • Assists in Protocol writing from the first draft to final version, including amendments to the Protocol throughout the trial, if required.
  • Conducts site qualification visits to ensure that the facilities and staff are adequate for conducting studies
  • Conducts site initiation visits to ensure sites and study staff are adequately trained and prepared to conduct a study.
  • Verifies that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects;
  • Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC;
  • Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.)
  • Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools);
  • Ensure accountability of Investigational Product and related supplies are performed, when appropriate;
  • Ensure complete reporting and proper documentation of monitoring activities;
  • Conduct routine monitoring visits (on site or remotely) independently from the investigative site study staff;
  • Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Must be able to lift and carry up to 20 pounds in order to: pack, ship, move, unpack, set up and execute equipment for study at clinical site, repack and ship back to Brain Sentinel. Must be able to travel up to 25-50% of the time, both local and domestic (& possibly international), so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Qualifications and Skills

Minimum Qualifications:

  • Experienced with Good Clinical Practice (GCP) in conduct of clinical studies;
  • Experience in Clinical Research Trials, minimum 2 years
  • Excellent written and verbal communication skills essential;
  • Must be capable of interacting with all levels of management, coworkers, investigators and subjects;
  • Proficiency with Microsoft Office, computer data acquisition, and report writing
  • Ability to independently set and manage multiple priorities;
  • Demonstrates advanced judgment and decision-making ability in the execution / oversight of clinical study sites;
  • Ability to travel to data collection sites, local and domestic, may require up to 25-50% of time;
  • Ability to lift and carry up to 20 pounds;

Preferred Qualifications:

  • Experience with medical devices;
  • Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology);
  • Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements;
  • Preferably certified as a Clinical Research Associate;

Education

  • Bachelor’s degree, preferable in Science or in a related field is required.
  • CRA certification training is preferred.
  • Combination of education and related experience will be considered in lieu of a bachelor’s degree.

Job Type: Full-time

Job Location:

  • San Antonio, TX

Required education:

  • Bachelor's

Required experience:

  • Clinical Trials: 2 years
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