Human Subjects Protection Scientist (HSPS) II Mid Level

This position is contingent on a contract award.

Serves as the administrative reviewer of protocol submissions in Post-Approval Oversight. Provides limited initial review support tasks as needed. Is a subject matter expert in Human Subjects Protection and serves as an information resource for the government and investigators submitting protocols for review for the US Army Medical Research and Development Command (HQ USAMRDC).

• Provides oversight of research protocols through timely documented reviews of lifecycle submissions to assure ongoing compliance with all applicable human subjects protection regulatory requirements.

• Timely reviews protocol submissions (and associated documents such as 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 use requirements.

• Provides comprehensive, timely, professional quality and fully documented initial reviews of research supported by the government.

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

• Provides a comprehensive review and evaluation of human subjects research protocol amendments/addenda, continuing review reports, protocol continuations under new USAMRDC awards, reports of unanticipated problems and serious adverse events, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, final study reports and provides a professional quality written review.

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

• Supports noncompliance investigations and compliance inspections of extramural protocols.

• Interprets and applies federal human subjects protection requirements and makes 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. Actively managing and updating protocol files and the information management systems to track information related to protocol reviews.

• 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.

• All other duties as assigned.

Other Job Requirements

Responsibilities

Bachelor's degree required.

5 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.

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 interpersonal, organizational, and project management skills.

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

Demonstrated communication, critical thinking, and decision-making abilities.

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) II Mid Level

Grade

26

Work Experience - Required

Human Research Protection

Work Experience - Preferred

Education - Required

Bachelor's

Education - Preferred

License and Certifications - Required

License and Certifications - Preferred

CIP - Certified IRB Professional - Enterprise

Salary Range

Salary Minimum:

$70,715

Salary Maximum:

$113,145

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.