Research Compliance Analyst III

Socket.dev; New Orleans (LA); On-site; USD 70,000 - 100,000; Full time

Job summary

Tulane University is seeking a regulatory compliance professional to provide consultation to researchers and the IRB, ensuring adherence to regulations, ethical standards, and institutional procedures. The role includes developing and delivering education, training, and outreach to protect human subjects.

The candidate will review reportable events, advise on regulatory compliance, and support post-approval monitoring initiatives while engaging with faculty, IRB members, and HRPO personnel.

Qualifications

• Ability to research and interpret regulations and standards applicable to research.
• Excellent organizational and communication skills.
• Ability to communicate with researchers, senior administration, regulators, and sponsors.
• Ability to meet deadlines and work independently.

Responsibilities

• Research and interpret federal, state, local, and international regulations and policies.
• Proficient in MS Word, PowerPoint, Access, and other Windows applications.
• Organize and communicate effectively with stakeholders.
• Communicate with researchers, regulators, and sponsors.
• Meet deadlines and manage multiple projects simultaneously.
• Maintain confidentiality in all work performed.

Skills

Regulatory research

Communication skills

Organizational skills

Travel flexibility

Education

Bachelor’s Degree + 3 years experience

High School Diploma + 9 years experience

Tools

MS Word

PowerPoint

Access

Job description

Ensures that research projects meet regulatory and ethical standards by providing professional consultation to researchers and to the Institutional Review Board (IRB) or any other boards that regulate research. Ensures that researchers comply with regulations, ethical standards, and institutional procedures to protect human subjects through a robust education, training and outreach program, which includes but is not limited to, Post Approval Monitoring responsibilities and initiatives. The targeted audience for training initiatives are research faculty and staff, IRB Members, and HRPO personnel. Oversees the review of reportable events and presents to the Institutional Review Board (IRB), as needed. Provides consultation to researchers and board members on regulatory and procedural compliance, in accordance with the HRPO SOPs. Develops and delivers compliance training programs to prevent non-compliance during the conduct of research.

Responsibilities

• Ability to effectively research and interpret regulations (federal, state, local, and international), institutional policies, and accrediting body standards applicable to research.
• Working knowledge of various standard word processing and database software required; specific experience using Microsoft Word, PowerPoint, Access, and other windows based applications preferred.
• Excellent organizational and communication skills.
• Ability to communicate articulately with researchers, senior administration, regulators, and sponsors.
• Ability to meet established deadlines and make decisions independently.
• Ability to assist and provide guidance to co-workers.
• Highly organized and detailed oriented individual.
• Ability to work on a number of projects simultaneously and ability to prioritize projects.
• Ability to maintain confidentiality in all work performed.
• Ability to work evenings and weekends, as needed.
• Ability to travel, as needed.

Qualifications

• Minimum Qualification:
• Bachelor’s Degree and three (3) years of human subjects clinical research experience, including legal and/or regulatory research experience.
• OR
• High School Diploma/Equivalent nine (9) years’ human subjects clinical research experience, including legal and/or regulatory research experience.
• Within two (2) years of hire date, must attain at least one of the following certifications: IRB Professional Certification (CIP) or Healthcare Research Compliance Certification (CHRC).
• Preferred Qualification:
• Juris Doctorate or other advanced degree, or a combination of Bachelor’s Degree with three to five years of experience working in human subjects research either in the capacity as a researcher or research management.
• Three to five years of experience working under or with regulatory statues, guidance, policies, and standard operating procedures pertaining to research.
• Knowledge of the Health Insurance Portability and Accountability Act (“HIPAA”).
• Experience with writing policies and standard operating procedures.
• Public speaking experience.
• Certified Institutional Review Board (“IRB”) Professional (“CIP”) or other certification related to research administration or oversight.

Tulane University is an equal opportunity educator and employer committed to providing an education and employment environment free of unlawful discrimination, harassment, and retaliation. Legally protected demographic classifications (such as a person’s race, color, religion, age, sex, national origin, shared ancestry, disability, genetics, veteran status, or any other characteristic protected by federal, state, or local laws) are not relied upon as an eligibility, selection or participation criteria for Tulane’s employment or educational programs or activities.