Human Subjects Protection Scientist
Human Subjects Protection Scientist
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Salary Not Disclosed
1 Vacancy
Job Description
Do you have a passion for ensuring the highest ethical standards in human subjects research Are you excited to support the government and clinical researchers in ensuring safe and effective research protocols
Ripple Effect is looking for multiple Human Subjects Protection Scientists with regulatory and oversight experience in biomedical human subjects research to support our clients mission. In this role you will serve as the initial protocol reviewer and lead teams of reviewers within the office. You will be a subject matter expert in Human Subjects Protection and 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 are a diverse progressive and engaging work environment. We offer a multitude of incentives and flexible work options that work for you and your lifestyle.
General Information
- Job Code: SHRRA03 04T 05M
- Location: Positions in the MD VA and DC area
- Employee Type: Exempt FullTime Regular
(Ask our recruiters about flexible work arrangements - Telework: Hybrid 23 days per week inoffice)
- Travel: May require occasional CONUS and/or OCONUS travel for site visits
- Security Clearance: NACI and up to Secret (depending on position)
- Citizenship: Not required but must be eligible to work in the United States without sponsorship
- Number of Openings: Multiple
- Salary Range: $82858 to $137213 (how we pay and promote
Responsibilities
- Pre and Initial Proposal Reviews: Conduct prereviews of projects submitted for applicability of the human subjects protection regulations. Provide timely review of proposal submissions (and associated research protocols consent forms IRB approvals and recruitment materials) submitted to ensure compliance with all applicable Federal DoD DA state host nation and human subjects protection regulatory and cadaver use requirements.
- Detailed Research Protocol Reviews: Provide regulatorybased written initial reviews and consultation of protocols using standardized checklists and expertise. Formulate and recommend potential solutions to complex problems that would bring protocols in compliance with laws regulations policies procedures and guidelines governing human subjects research and cadaver use.
- Compliance Oversight & Consultation: Interpret and apply 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. Identification and assessment of noncompliance when the research is conducted prior to approval. Responsively engage in email and telephone communication with the Principal Investigator the Approval Authority and key study personnel to address questions concerns and outstanding issues.
- Administrative Support: Provide accurate information assistance and documents to customers. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of working materials to facilitate review of future actions by team members. Complete administrative review actions for protocols in postapproval oversight.
- Training & Documentation: Develop and update SoPs and checklists to support quality management. Develop and conduct training and resource materials to facilitate knowledge of most recent regulations and overall success of the human research protections program.
Requirements
Minimum Education and Experience
- BA/BS in a life science biomedical or related field
- 6 years of relevant professional experience
Basic Requirements
- Expertise in the various laws regulations policies procedures and guidelines governing human subjects research and cadaver use.
- Experience in the management and oversight of human subjects research ethics including knowledge of IRBs and privacy protection regulations.
- Experience reviewing and making determinations of exempt expedited or full board review on human subjects research protocols.
- Expertise to provide reviews of all types of research including but not limited to research involving human subjects cadavers human data and biospecimens to ensure compliance with all applicable regulatory requirements and to delineate deficiencies and areas of noncompliance.
- Ability to prioritize among multiple projects in a fastpaced deadlinedriven environment relying on your own resources and initiative.
- Must work effectively in a team environment.
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
- Masters degree in a related field
- Relevant certifications e.g. CIP SOCRA etc.
- CITI training in accordance with local IRB policy
- Experience in either servicing on or the administration of an IRB
- Experience as a government contractor supporting biomedical or health research programs within the DoD
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.
Benefits
Ripple 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 race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender identity political affiliation or Veteran status. 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.
Employment Type
Full-Time
