DescriptionDo you have a passion for ensuring the highest ethical standards in human research protection Are you excited to support the government and clinical researchers in ensuring safe and effective research protocols
Ripple Effect is looking for a Human Research Protection Lead Analyst who holds a TopSecret clearance and has regulatory and oversight experience in biomedical human research protection to support our clients mission. In this role you will provide programmatic and task management support for the clients compliance assurance program. Additionally you will be a subject matter expert in Human Research Protection regulations policies and guidelines. You will serve as an information resource for the government and investigators submitting protocols for review. You should have the experience and expertise to review any submission type.
If this position sounds of interest theres a place for you here at Ripple Effect! We offer a diverse and engaging work environment with a multitude of incentives and flexible work options that work for you and your lifestyle.
General Information
- Job Code: SHRRA05M
- Location: DC Metro Area
- Employee Type: Exempt FullTime Regular
(Ask our recruiters about flexible work arrangements - Telework: Hybrid
- Clearance: TopSecret
- Citizenship: Required by Government Contract
- Manager: Yes
- Number of Openings: 1
- Salary Range: $119316.00 $130000.00 (how we pay and promote
Responsibilities
- Program Management and Administration: Support the development of the policies structures and processes necessary to sustain the work of the human research protections group. Support Department of Homeland Security (DHS) program management meetings and maintain communications with compliance offices in other departments and agencies as well as external regulatory entities.
- Information Management: Collect analyze track store and archive compliance program information through a database shared drive etc. Support the development and maintenance of compliance review database(s).
- Program Compliance: Plan and execute postapproval compliance activities prepare compliance assessments and record compliance activities. Inform stakeholders of applicable compliance issues and concerns. Provide guidance and recommend actions to resolve deficiencies and achieve compliance.
- Training & Outreach: Develop processes facilitate events and provide instructional support to establish and maintain awareness of human research protections compliance requirements.
- Policy Support: Support DHS policy development including support for DHS in interagency and international meetings preparation of briefing materials data calls related to research compliance and alerts substantive analysis and recommendations to address current issues. Maintain ongoing awareness of emerging trends in compliance as they relate to human research protection to inform policy support activities.
RequirementsMinimum Education and Experience
- MA/MS in the sciences health policy law or information technology (IT)
- 10 years of relevant professional experience
Basic Requirements
- Current TS/SCI clearance
- Experience in the management and oversight of human subjects research ethics including knowledge of IRBs and privacy protection regulations.
- Expertise in applying laws regulations policies procedures and guidelines governing human research protection.
- Experience reviewing and making determinations of exempt expedited or full board review on human research protocols.
- Expertise to provide reviews of all types of research involving human research human data and biospecimens to ensure compliance with all applicable regulatory requirements and to delineate deficiencies and areas of noncompliance.
- Experience with or ability to assist in the development of policies and procedures based upon Federal state local and other laws policies and guidelines.
- Ability to analyze extremely complex problems and recommend monitor and execute best practice solutions to executive level management.
- Ability to prioritize among multiple projects in a fastpaced deadlinedriven environment relying on your own resources and initiative.
- Demonstrated prior management experience including training of junior analysts and organizing work assignments for the team.
To be successful at Ripple Effect you must be able to pay attention to details clearly communicate work independently and have an eagerness to learn. Learn more about what makes Ripple so great: check out our capabilities!
Skills That Set You Apart
- Relevant certifications e.g. CIP SOCRA etc.
- Experience in either serving on or for the administration of an IRB or other ethical committee.
- Experience as a government contractor supporting biomedical or health research programs within the DHS or other federal systems.
- Experience in compliance monitoring and/or auditing within the research enterprise.
- Available to travel nationally.
If you dont have all of the skills above dont be discouragedno resume paints a complete picture of a person. Theres a good chance youre more wonderful than you think so please apply!
About Ripple Effect
Ripple Effect is an awardwinning womenowned small business providing professional consulting and exceptional talent for federal private and nonprofit clients. We deliver multidisciplinary solutions across Communications & Outreach Research & Evaluation Program Management & Policy Digital Transformation and Technical & Scientific Support solutions with a focus on science research and healthcare domains.
Hiring Process Life at Ripple
BenefitsRipple Effect rewards our employees for their contributions to our mission in many ways from competitive pay and exceptional benefits to a range of work/life programs based on your employment classification and personalized preferences.
Ripple Effect is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of to race color religion sex national origin age 40 or older) disability or genetic information. We also consider qualified applicants regardless of criminal histories consistent with legal requirements. If you have a disability or special need that requires accommodation during the hiring process please let us know by contacting our HR department at or your recruiter. Eligibility for employment will be verified using Everify.
Required Experience:
IC