Job Overview

Summary

Vacancy ID: 931814 

OUR MISSION: To fulfill President Lincoln’s promise – “To care for him who shall have borne the battle, and for his widow, and his orphan” – by serving and honoring the men and women who are America’s Veterans. How would you like to become a part of a team providing compassionate care to Veterans?

The Department of Veterans Affairs (VA) needs employees who possess the energy, compassion, and commitment to serve those who served our Country. Whatever the job title, every position in VA will give you a chance to make a meaningful and personal contribution to the lives of truly special and deserving people - our Veterans. VA professionals feel good about their careers and their ability to balance work and home life. VA offers generous paid time off and a variety of predictable and flexible scheduling opportunities. Working for VA is one of the most emotionally satisfying and professionally rewarding ways to dedicate the best within you to your Country's service. If you are transitioning from the military or a Veteran already, we invite you to explore the benefits of continuing your career at the VA. The VA is committed to hiring Veterans.

The VA is much more than just another employer. It is an honorable, open and welcoming community of those who care. Gratitude is our motivation and service is our mission.

The VA has adopted Core Values and Characteristics that apply universally across the Department. The five Core Values define “who we are,” our culture, and how we care for Veterans, their families and other beneficiaries. The Values are Integrity, Commitment, Advocacy, Respect and Excellence (“I CARE”).

America's Veterans need you! To find out more, go to http://www.va.gov/jobs/.

Duties

NOTE: This is a TERM appointment (not-to-exceed 2 years). Term appointments are non-status, non permanent appointments of limited duration. Term employees are eligible to earn leave and generally have the same benefits as permanent employees including health and life insurance, within-grade increases and Federal Employees Retirement System and Thrift Savings Plan coverage. Term appointments may be extended without further competition. 

Employee will be assigned to the Cooperative Studies Program (CSP), VA Palo Alto Healthcare System, Mountain View, CA. CSP research studies are large complex studies with voluminous administrative responsibilities with each study consisting of several different sites with two to four staff at each site requiring various administrative needs as well as monitoring for research compliance.  Duties include, but may not be limited to the following:
  • Tracks the annual Institutional Review Board (IRB) and Research and Development (R&D) approval status for each site to ensure compliance; and enters and tracks approval dates for IRB and R&D renewals in study database.
  • Reviews submitted consent forms prior to the start of the study and performs ongoing review of patient signed Informed Consent Forms (ICFs) for completeness and accuracy throughout the course of the study; and initiates contact with sites to resolve ICF queries that arise, and once complete, enters them into the Center's electronic data capture software.
  • Performs audits of all regulatory documents pertaining to sites for completeness and compliance with Good Clinical Practices (GCP) and other organizational requirements and CSP regulatory guidelines.
  • Tracks GCP and Human Subject Protection (HSP) trainings for all site personnel within a study to ensure study maintains compliance with regulatory requirements; and maintains and monitors the Central Study Files for assigned studies according to Center-Wide and Global Standard Operating Procedures (SOPs).
  • Produces and distributes study documents (i.e., Study Protocol, Operations Manual, and Study Newsletter).
  • Assists with planning, reviewing and reporting of statistical results for assigned studies; and extracts and assembles information, conducts analysis, and develops reports for presentations.
  • Updates the SharePoint site (i.e., adds study documents, training dates, personnel lists, etc.).
  • Assists the Travel Coordinator with coordinating study meetings; takes minutes; and serves as timekeeper.
  • Serves on one or more committees; and trains new administrative employees.

WORK SCHEDULE: Monday – Friday, 8:00am – 4:30pm.

***RELOCATION EXPENSES AND/OR INCENTIVES ARE NOT AUTHORIZED***