Description

Ready for a rewarding career opportunity?

Unleash Your Potential at Leidos, where we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customer's success. We empower our teams, contribute to our communities, and operate sustainably. Everything we do is built on a desire to do the right thing for our customers, our people, and our community. Our Mission, Vision, and Values guide the way we do business.

If this sounds like an environment where you can thrive, keep reading!

Are you a skilled IRB Administrator looking for a new opportunity? Look no further than Leidos! We are seeking a Research Coordinator-Institutional Review Board (IRB) Administrator to support intramural human use research at the Naval Medical Research Unit Dayton, OH (NAMRU D). As our successful candidate you would be reviewing documents, drafting communications, maintaining records and documents, and assisting with audits.

Join our team and make a difference in the lives of our nation's warfighters - apply today!

Your greatest work is ahead!

The Mission

Recognized as a Top 10 Health IT provider, the Leidos Health Group draws on decades of success to deliver a range of solutions and services designed to meet the healthcare obstacles of today. From the research bench to the patient bedside, we are a company of scientists, engineers, and technologists delivering a broad range of impactful, customizable, and scalable solutions to hospitals and health systems, biomedical organizations, and every U.S. federal agency focused on health. Leidos works with customers across the continuum of care to improve clinical, operational, and financial outcomes with innovative solutions that advance the next generation of care. Our mission is to contribute to creating a healthier world. To explore and learn more, click !

Are you ready to join a team dedicated to a mission? Begin your journey of a flourishing and meaningful career, send your resume to us today!

Your Main Objective:

• Provide IRB management and coordination for intramural human use research working with PIs and Research Assistants of all levels to coordinate IRB activities and ensure accomplishment of protocol requirements.

• Promote the NAMRU D IRB functions and HIPAA Privacy Office functions by reviewing all studies for compliance with DoD, Navy, and federal regulations.

• Identify needed changes to study teams for Exempt, Expedited, Full-Board (Initial, Continuing, and Modification) reviews including projects that are FDA-regulated.

• Draft formal approval letters, information-needed memos, emails, and other written communication according to site-specific, Navy, and DoD, and DHHS guidelines.

• Maintain IRB records and IRB meeting minutes to document compliance with relevant human subject protection regulations.

• Maintain document archives in electronic and paper format according to DoD regulations.

• Maintain training files and assist personnel with training specifications and technical assistance.

• Create and maintain tracking system for Not Human Subject Research determinations and Data Use Agreements.

• Assist with site audits as needed, in particular with HIPAA compliance.

• Demonstrate knowledge of the federal regulations on human research protection.

What Sets You Apart:

• BS/BA with 4 or more years in a relevant scientific field.

• 4 or more years of experience in IRB review; including IRB communications and coordination of IRB submissions.

• 1 or more years of experience in research administration or project management in an academic or research environment.

• Certified IRB Professional (CIP) or must obtain within 1 year; Certified Clinical Research Certification (CCRC) considered.

• Strong written and oral communication skill to be able to work effectively with a highly diverse group of people.

• Effective organizational and analytical skills- must be highly organized, demonstrating strong attention to detail and accuracy.

• Ability to work both on your own and as a team member, in fast-paced, demanding, research environment in an effective and flexible manner.

• Proficient with Windows based computer systems including

  MS Office

• Ability to obtain and maintain Secret security clearance

• Due to federal contract needs, must be a US Citizen.

You Might Also Have:

• A Master's degree (preferred)

• Experience in a military or medical research environment is highly desired.

• Experience with human subject research helping with management of research compliance (HIPAA, Privacy) with investigators and other research staff.

At Leidos, the opportunities are boundless. We inspire our staff with interesting assignments that allow them to thrive professionally and personally. For us, helping you grow your career is good business. We look forward to learning more about you - apply today!"

While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.

The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.