Quality Control Associate

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Headquartered in San Antonio, Texas, Summit Clinical Research is an Integrated Research Organization dedicated to Non-Alcoholic Steatohepatitis (NASH) clinical trials, that delivers a full spectrum of study enrollment and site enrichment services to sites and sponsors in our network. From our inception in 2018, Summit has increasingly built a leadership team of uniquely specialized physicians, and clinical operations team professionals that span the health care industry.

At Summit, we strive to be on the forefront of innovative research by continuing to educate and expand our knowledge in the ever-changing landscape of Liver Disease treatment. As a network, we build upon each other’s successes to empower and inspire one another to achieve greater heights. Summit Clinical Research is committed to company culture, employee retention, and superior therapeutic areas of focus.

Come be a part of our great team!

 

Job Title: Quality Control Associate

Reports To: Director of Quality Control

FLSA Status:

 

Overall responsibility:  The Quality Control Associate works under the supervision of the Director of Quality Control (QC) and in accordance with industry Regulations, Summit Clinical Research’s policies, Standard Operating Procedures, and Statements of Work to achieve and maintain quality within the organization.  The QC Associate will be responsible for visiting prospective clinical research centers to verify the staff and facility meet Summit’s requirements for inclusion in the network.  Sites within the network will be visited by the QC Associate to ensure the quality standards and objectives are being fulfilled for continued collaboration in the network.

Key tasks:

  • Conduct clinical research site qualification visits
  • Perform clinical research site quality assessments
  • Complete detailed reports and summaries of site visits
  • Review clinical trial protocols to create source documents using established templates and electronic platforms
  • Assist the Director of QC with preparing clinical research sites for audits and/or regulatory inspections
  • Present training materials as developed by the Training and Compliance Manager

 

Requirements:

  • Proficient written and verbal language skills
  • Basic computer skills
  • Attention to detail and analytical skills
  • Ability to interact with Sponsor and site representatives
  • High-level of integrity
  • Good understanding of pharmaceutical clinical trial conduct
  • Familiar with clinical trial protocol elements
  • General understanding of Good Clinical Practice, FDA Code of Federal Regulations 21 CFR 312 and ICH E6 (R2)
  • Able to travel domestically 30-40%

 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 Supervisory Responsibilities:

  • There are no direct supervisory responsibilities for this position.

 Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         Minimum of 3 years in pharmaceutical clinical research and/or

·         Bachelor of Science Degree

OR
 
 
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