Consultant- Research Compliance

Cincinnati Children's Hospital Medical Center Cincinnati , OH 45201

Posted 2 weeks ago

CAREER LEVEL SUMMARY: In-depth conceptual and working knowledge in job area; familiarity in related disciplines/specialties. Requires minimal guidance, may lead projects of manageable risk or have accountability for ongoing activities or objectives. Deep experience in role; able to train / may lead others in job area. Executes wide range of difficult / complex tasks. Level at which career may stabilize for many years or until retirement

DEPARTMENT:Cincinnati Children's Research Foundation (CCRF)

SUPERVISOR'S TITLE:Director, CCRF/ Chair of Pediatrics

TOTAL NUMBER OF FTEs DIRECTLY SUPERVISED: 0-5

TOTAL NUMBER OF FTEs INDIRECTLY SUPERVISED: 0

PURPOSE OF POSITION: Serve as the identified institutional expert in the specified area of research compliance including export, regulatory, administrative and represent CCHMC at the national and regional level within research consortiums, working groups and task forces.

Representative Responsibilities

Regulatory Knowledge & Oversight

  • Maintain status as a regulatory expert with regard to Export Control functions, remain current through formal and informal networks and interactions on national trends regarding Export Control. Forecast/predict future state based on in depth knowledge and interconnectedness with key individuals across the country and within regulatory agencies. Educate on best practices both internally and externally. Ability to interpret and analyze the concepts and principles of federal and state law, institutional policies/procedures/guidance and professional guidance as it relates to the review and oversight of research and assess the impact of specific regulatory decision on the overall research environment at CCHMC.

Export Control/Compliance

  • Responsible for the development, oversight, management and record keeping aspects of the CCHMC's export control compliance program. Monitor the federal laws, rules and regulations that pertain to export controls and develop or revise, as needed, CCHMC's policies and procedures, as well as the education and communication tools necessary to ensure compliance. Serve as the primary point-of-contact with the respective government agencies for compliance with the International Traffic in Arms Regulations (ITAR) under the auspices of the U.S. Department of State; the Export Administration Regulations (EAR) under the auspices of the U.S. Department of Commerce and the Office of Foreign Assets Controls (OFAC) regulations under the auspices of the U.S. Department of Treasury. Act as primary point of contact for all internal and external inquiries regarding Export Control compliance Advise the faculty on regulatory requirements and provide leadership and direction in Export Control. These areas include disclosure review, policy development, compliance committee work and outreach and training. Provide guidance to stakeholders regarding decisions that have import/export regulatory impact. Implement and administer procedures for exports and travel. Review sponsored program proposals and awards, determine need for Technology Control Plans (TCPs) and/or licenses. Resolve TCP issues with PIs: document all determinations. Review all H-1B visas, J-1 scholar visas and international agreements for relative risk for export controls. Monitor all international shipments, determine need for export licenses, Draft and submit license applications and institutional registrations in conjunction with the Office of General Counsel.

Leadership/Management

  • Independently leads in the development of a comprehensive regulatory and compliance program and infrastructure in support of the institution's research strategic plan. Recommends solutions that maximize organizational performance. Represent CCHMC at the regional and national level disseminating best practices,

Teamwork & Collaboration

  • Work collaboratively with diverse teams and interface effectively with internal and external stakeholders at multiple organizational levels. Build consensus among stakeholders with competing priorities and Negotiate competing interests and gain commitment to achieve institutional priorities. Coordinate efforts throughout Research Administration to ensure that efforts remain consistent with CCHMC strategic goals; as it related to COI and Export Control. Use project management and organizational skills to lead institutional initiatives. Lead project team consisting of both internal and external members and to achieve successful outcomes through both direct and indirect leadership.

Institutional Support

  • Serve as subject matter expert in management plan development and maintenance of export control policy and procedures. Secondary reviewer of financial disclosures submitted by CCHMC researchers or referred by Analyst to ensure compliance with applicable federal regulations, state statutes and CCHMC policies, principles and procedures. .Identifies level of non-compliance and advises stakeholders of appropriate action

Education/Experience

Required:

  • Bachelor's degree AND 7 years' directly related experience. OR

  • Master's Degree AND 5 years directly related experience

  • For Human Research Program- (HRP) For IRB-Certified IRB Professional (CIP)

Preferred:

  • M.S., M.A., J.D. or other advanced degree

  • Familiarity and knowledge of federal regulations pursuant to EAR, ITAR and OFAC.

  • Experience at an academic research organization

Unique Skills

  • Research Expertise: Extensive experience in academic research, research administration and compliance; sponsored research and compliance experience in higher education.

  • Technology Expertise: Extensive experience in technology or technical data classifications according to the federal regulations, and the submission and management of export and deemed export licenses is essential. Familiarity with the Automated Commercial Environment (ACE)/Automated Export System (AES) and Visual Compliance or similar export control software is highly desired.

  • Compliance Expertise:Prior experience creating and implementing compliance strategies and technology control programs Knowledge of federal export control regulations including those pursuant to EAR, ITAR, OFAC, and National Security Decision Directive 189.

  • Judgment and discretion

  • The ability to make effective decisions, problem solve and handle confidential information with discretion.Diversity Appreciation

Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others' perspectives and ideas; appreciating cultural differences and adjusting one's approach to successfully integrate with others who are different from oneself

  • Professional Demeanor

Demonstrates an independent work initiative, sound judgment, diplomacy, tact and professional demeanor

  • Communication
  • Advanced

Excellent verbal, written and interpersonal communication skills.

  • Clinical Research

Quality Improvement

  • Research Method Skills

Documentation

Outstanding documentation and attention to detail

  • Leadership

Must possess leadership skills and have the ability to relate to a diverse group

  • Organization

Must have advanced organizational skills as well as strong analytical and problem solving skills

  • Teamwork

Must have teamwork skills as well as the ability to prioritize and demonstrate critical thinking

  • Independence & Collaboration

Must also have the ability to work independently and collaboratively with multiple departments while utilizing innovation to elicit compliance

  • Computer Skills

Must be computer literate with software applications

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Consultant- Research Compliance

Cincinnati Children's Hospital Medical Center