Regulatory Associate

WVU Research Corporation - Morgantown, WV3.9

Full-time
The West Virginia University Research Corporation is seeking applications for a Regulatory Associate. This position is responsible for assisting with coordination of the research activities for the WVU School of Medicine, Department of Pediatrics. The incumbent will work jointly with the Principal Investigator on related studies and research for funded and non-funded studies in the department.
In order to be successful in this position, the ideal candidate will:
  • Assist the clinical trials team with sponsored clinical trials (industry and governmental) and comply with sponsor requirements and associated legislation, regulations, guidelines, and policies governing the conduct of human subject research.
  • Assist with the planning, development, implementation, tracking and evaluation of established milestones and goals.
  • Assist Primary Investigator on clinical trials with human subjects.
  • Assist with research protocols in accordance with West Virginia University's Institutional Review Board.
  • Obtain and process laboratory specimens.
  • Prepare research data and findings.
  • Perform literature searches.
  • Perform statistical analysis, interpretation of data and preparation of scientific manuscripts for publication.
  • Develop and maintain research databases.
  • Oversee and conduct investigations, perform audits and serve as agency audit host.
Qualifications
  • Bachelor's degree in a public health, critical care nursing, medical research or a related field
  • One (1) year of broad based experience in the following:
  • Controlled clinical trials involving human subject research
  • Obtaining and processing laboratory specimens of blood/urine
  • Operating refrigerated centrifuge
  • An equivalent combination of education and experience may also be considered
  • Maintain knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adhere to industry and government standards
  • Knowledge of institutional policies and procedures within an academic medical center
  • Familiarity with federal and state regulations and guidelines pertaining to the conduct of clinical trials with human subjects
  • Familiarity with sound principles, methods, systems and processes for controlled clinical trials involving human subject research, Institutional Review Boards and that related to medical records management (e.g., HIPM)
  • Ability to plan and implement short- and long-range tasks to realize objectives within timeline constraints
  • Conduct literature searches and chart abstractions
  • Working knowledge of statistical data collection, analysis, tracking, and reporting systems, methods, and techniques
  • Ability to read. understand, and evaluate patient charts, patient histories. treatment plans, and other medical records and report and/or discuss findings in a confidential and professional manner
  • Skilled in utilizing office equipment. PC's, various computer application and programs, and laboratory equipment
  • Assist with writing reports and presenting trial data for conferences and publications
  • Ability to operate a refrigerated centrifuge and decanting skills
  • Knowledge of and ability to safely handle body fluids
Requirements

About Research Corporation AA/EOE/Minorities/Females/Vet/Disability/E-Verify Compliant Employer.

Please view Equal Employment Opportunity Posters provided by OFCCP here.

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Competitive salary and benefits offered. For a complete job description and to apply for this position, please visit http://hr.research.wvu.edu and click on the “View Jobs” link. AA/EOE/Minorities/Females/Vet/Disability/E-verify compliant employer

Job Posting: Oct 1, 2018
Posting Classification: Research Corporation
Exemption Status: Non-Exempt
Benefits Eligible: No
Schedule: Full-time