- Independently reviews and provides determinations regarding individual and institutional engagement in research involving human subjects and coordinates agreements with other compliance and regulatory requirements.
- Process all IRB reliance agreements and sIRB requests when NU has agreed to serve as the IRB of Record and when NU is relying on another IRB
- Evaluate requests against established criteria and on occasion, draft agreements using established templates, reviewing non-NU institutional templates to ensure required elements are present.
- Coordinates with other units on campus when establishing data use agreements and material transfer agreements.
- Local context: Provides local context information to other IRBs and reviews changes in the research that may impact NU local context requirements. Obtains local context from relying institutions.
- Reviews research-related events on reliance-specific studies reviewed by a NU IRB, which may include non-compliance, deviations, complaints, and violations by researchers and forward to the appropriate parties for possible action
- Tracks agreement execution status, uploads documents to online repositories, and develops and maintain records of research activities.
- HRPP Staff: Identify needed areas of training for staff, identify educational resources, and assist the Executive Director in the development of an HRPP training and professional development program.
- IRB Members: Train new IRB members and develop a continuing education program for the compliance committee(s).
- Research Community: Support campus education initiatives and identify education gaps and develop appropriate trainings to Northeastern students, research groups, and study teams.
- Demonstrates a working proficiency in ability to work with a variety of individuals and groups in a constructive and collaborate manner, including strong writing, public speaking and presentation skills.
- Understand, interpret, and apply University, State, and federal regulations related to human subject research (e.g., FDA, HIPAA, FERPA, DHHS/OHRP).
- Ability to prioritize and coordinate multiple tasks, with the ability to prioritize and organize communications and reports, meet deadlines, and understand and appreciate the tasks and processes required.
- Ability to meet or exceed customer service needs and expectations and provide excellent customer service at a working level of proficiency.
- Technical experience with data management system or electronic workflow system.
- Working experience reviewing, editing, or submitting IRB applications for compliance with federal regulations.
- Engage in continuing professional development activities to improve knowledge of technical and ethical aspects of human subject research.
- A minimum of 1 year experience conducting and/or monitoring research involving human participants, or in a related administrative role supporting human subject's research working with federal regulations.
- Experience working within a research extensive (R1) university environment.
- Managing daily operations and staff in a demanding research environment.
- Proven knowledge to interpret and apply university, state, and federal regulations and policies as they pertain to human subject research.
- Demonstrated ability to perform effectively, both independently and as a team member, with a professional demeanor in a diverse and fast-paced work environment consisting of multiple and changing priorities, under minimal supervision.
- Strong communication skills, both written and verbal.
- Ability to incorporate knowledge gained from access to continuing professional development opportunities.
- Bachelor's degree required; in a scientific, social science, or humanities discipline. Alternate degree fields will be considered/accepted based upon the nature and depth of the experience as it relates to this position.
- Eligible and willing to become certified by the Council for Certification of IRB Professionals [CIP].
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Human Subject Research Protection Coordinator - Boston, United States - Khoury College
Description
About the Opportunity
.
JOB SUMMARY:
Responsible for managing reliance agreements and sIRB requests for studies where NU is IRB of Record and for where NU is relying on another IRB. Develop and execute training and education program for all members of the NU research community.
JOB DUTIES:
30% Reliance Agreements and External Sites Liaison
30% Training, Education & Outreach
30% Subject Matter Expertise
10% Other Duties as Assigned
POSITION REQUIREMENTS & QUALIFICATIONS
Position Type
Research
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