Portland VA Research Foundation
  • 21-May-2021 to 20-Jul-2021 (PST)
  • Research - Graff
  • Portland, OR, USA
  • Full Time

Health, Dental, Vision, Life & Disability, 401k, PTO


Regulatory Coordinator

SUMMARY

This position will entail assisting in in the coordination and execution of multiple elements in human subjects research and standard of care within the VA Portland Health Care System (VAPORHCS) Precision Oncology Program for Cancer Prostate (POPCaP), with primary emphasis on regulatory maintenance of trials. Duties include enrollment, patient logistics and management, regulatory compliance, data quality, and other approved enhancements of research efforts. Flexibility, time management, customer service, and a team-based aptitude are key.

ESSENTIAL DUTIES AND RESPONSIBILITIES

-Ability to work in a fast-paced environment and meet critical deadlines

-Ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time

-Ability to work well with other people as well as independently

-Critical thinking skills to interpret, implement, and facilitate clinical research protocols

-Project management and good communication skills

-Must be a self-starter

-other duties as assigned by the Investigator

JOB DUTIES

  • Oversee all regulatory tasks of clinical research trials including writing and submitting amendments, annual reviews, reportable forms, memos, consent form updates, and more
  • Ensure compliance with protocol, overall clinical objectives, and regulatory requirements
  • Manage the processing of all investigator brochures and safety reports
  • Maintain organized and accurate study records
  • Develop and maintain electronic databases
  • Manage administrative requirements such as those involving the IRB and other VA entities
  • Maintain a working knowledge of FDA and IRB guidelines that govern clinical research
  • Support coverage across the study team, stepping in when necessary to screen and enroll patients, request and review medical records, process lab specimens including stool, assist Principal Investigator with grant writing, and other study related tasks, as needed
  • Attend research coordinator educational opportunities at OHSU and the VA

QUALIFICATIONS

Ability to perform essential job duties with or without reasonable accommodation and without posing a direct threat to safety or health of employee or others. 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.

EDUCATION and/or EXPERIENCE

-Bachelor's degree or higher; preferably in a scientific or social science discipline

-Previous experience with human subjects' research

-Previous regulatory experience

LANGUAGE SKILLS

Clear written and oral communication in English with Veterans of all backgrounds

COMPUTER SKILLS

Basic proficiency with: MS Word, MS PowerPoint, MS Excel, MS Access, Outlook

REASONING ABILITY

Able to use critical thinking skills to make decisions that are within scope, and to recognize when decisions are out of scope.

PHYSICAL DEMANDS AND WORKING CONDITIONS

The physical demands and working conditions described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee may be occasionally required to lift and carry up to 25 pounds. The employee is regularly required to sit and stand; use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk.
  • The noise level in the work environment is usually moderate.

ALL ARE WELCOME

Portland VA Research Foundation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, color, sex, sexual orientation, gender identity, religion, national origin, or age. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply.

Please apply online at http://www.pvarf.org and include a CV/Resume, cover letter and list of 3 references.






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