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This position is contingent on a contract award.

Serves as the initial protocol reviewer, and leads review teams within the contract. Will review any and all submission types, provides guidance to team members. Is a subject matter expert in Human Subjects Protection and meant to serve as an information resource for the government and investigator's submitting protocols for review for the US Army Medical Research and Development Command (HQ USAMRDC).

+ Provides comprehensive, timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements.

+ Provides regulatory-based written initial reviews of protocols using standardized checklists.

+ Formulates and recommends potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use. This includes identification and assessment of noncompliance when the research is conducted prior to approval.

+ Provides human subjects protection regulatory consultation on selected proposals and pre-reviews of draft protocols.

+ Conducts pre-reviews of projects submitted for determination of the applicability of the human subjects protection regulations.

+ Completes administrative review actions for protocols in post-approval oversight.

+ Interprets and applies federal human subjects protection requirements and make regulatory review recommendations for any administrative review action required, from initial submission through lifecycle oversight to study closure.

+ Provides accurate information, assistance and documents to customers when requested with appropriate professionalism in a timely manner. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. Actively backups working materials to facilitate review of future actions by team members.

+ Responsively engages in email and telephone communication with the Principal Investigator, the Approval Authority, and key study personnel to address questions, concerns, and outstanding issues.

+ Trains and mentors new personnel, serves as an immediate expert resource for all team members, and collaborates with leadership to manage team workload.

+ All other duties as assigned.

Other Job Requirements

Responsibilities

Master's degree required.

8+ years of human research protection experience required.

Possesses knowledge, skills, and experience to interpret and apply federal human subjects protection requirements and make regulatory review recommendations.

Experience reviewing a variety of research including, but not limited to, research involving human subjects, cadavers, human data, and bio-specimens to ensure compliance with all applicable regulatory requirements.

Expert in applying human subject protection requirements to propose potential solutions to facilitate investigators’ conduct of compliant research.

Subject matter expertise in human research protection, including application of the Common Rule and subparts B, C and D; HIPAA; and other human research protection regulatory requirements.

Excellent verbal and written communication skills.

Strong analytical, decision-making and creative solving skills.

Strong interpersonal, organizational, and project management skills.

Ability to research, obtain, coordinate, and integrate feedback and directions from diverse operational groups and organizations into a written product.

Ability to manage multiple projects including planning, problem solving and time-management skills.

Must be able to work independently in current Microsoft Office Suite products.

Ability to obtain Tier 1 Clearance.

General Job Information

Title

Human Subjects Protection Scientist (HSPS) III - Senior

Grade

27

Work Experience - Required

Human Research Protection

Work Experience - Preferred

Education - Required

Master's

Education - Preferred

License and Certifications - Required

License and Certifications - Preferred

CIP - Certified IRB Professional - Enterprise

Salary Range

Salary Minimum:

$77,785

Salary Maximum:

$124,455

This information reflects the anticipated base salary range for this position based on current national data. Minimums and maximums may vary based on location. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors permitted by law.

This position may be eligible for short-term incentives as well as a comprehensive benefits package. Magellan offers a broad range of health, life, voluntary and other benefits and perks that enhance your physical, mental, emotional and financial wellbeing.

Magellan Health, Inc. is proud to be an Equal Opportunity Employer and a Tobacco-free workplace. EOE/M/F/Vet/Disabled.Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their position; and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures.