Linda Coleman Email & Phone Number

Palo Alto, Ca, Us

Stanford, Ca, Us

Responsibilities: • Oversee compliance in responsible conduct of research, conflict of commitment and conflict of interest, research security (including export controls and foreign influence), and data governance and privacy.• Lead the ongoing development, revision, communication, and implementation of Stanford’s research policies.• Assess the university’s needs related to research compliance and recommend strategies, approaches, and tools necessary to promote research compliance and protect researchers.• Coordinate institution-wide initiatives to prevent, detect, and respond appropriately to research compliance risks.• Collaborate with administrators and research compliance staff across departments and schools to implement and improve research compliance programs, clarify roles and responsibilities, and monitor compliance.• Develop, implement, and monitor a communication and education strategy regarding research compliance issues.• Monitor changes in the regulatory landscape, assess impacts for Stanford, and communicate outcomes to faculty and administrators.• Collaborate with central units such as the Research Compliance Office, the Office of Technology Licensing, the Office of Research Administration, the Office of Risk Management, and the Office of the General Counsel.• Strategize with the Vice Provost and Dean of Research and the Government Relations staff regarding compliance with policies and requirements of federal and state governments and foundations.• Represent Stanford in discussions and negotiations with government agencies.

New Haven, Ct, Us

Responsibilities:• Led Yale’s comprehensive Human Research Protection Program (HRPP).• Assessed HRPP policies and practices for operational efficiency, compliance, and quality.• Led various operational, compliance, and quality improvement initiatives and projects. • Collaborated with other HRPP components and external partners on strategic planning and cross-functional organizational initiatives. • Ensured organizational compliance with applicable laws, regulations, policies, and standards related to research. • Served as a lead for inquiries, audits, inspections, and site visits from sponsors, agencies, and accreditation bodies. • Liaised with the Office of General Counsel on research-related matters. • Managed Yale’s IRB, RDRC, RIDC, and Institutional COI committees, and collaborate on ancillary committee matters. • Served on University committees including the following: Investigator Conflict of Interest Committee; Institutional Biological Committee’s Human Gene Transfer Subcommittee; Clinical and Translational Research Oversight Committee; Data Safety Monitoring Committee; Cancer Center Clinical Trials Advisory Committee; Data Privacy Advisory Council (advisory to the Audit, Risk, and Compliance Committee); and Yale University/Yale New Haven Health System Health Data Governance Council. • Served as a co-investigator on grant focused on strengthening the HRPP and Office of Research Integrity at an institution outside of the United States.

Seattle, Wa, Us

Director of Regulatory Affairs (2007-2010)Director of Regulatory Affairs & General Counsel (2011-2015)Vice President of Regulatory & Legal Affairs (2016)Responsibilities: • Served as a member of the executive management team and collaborated on strategic planning and organizational initiatives. • Managed the organization’s legal, regulatory, compliance, quality, and consulting teams, including work assigned to external consultants and outside counsel. • Monitored changes in applicable laws, regulations, guidelines, standards, and policies. • Advised staff, IRB members, and research partners regarding the interpretation of laws, regulations, standards, and policies related to research conducted in the United States, Canada, and other countries. • Managed contracts. • Led compliance audit and monitoring program, including vendor audits, agency inspections, accreditation, and internal audits.• Evaluated, developed, and implemented policies, procedures, work instructions, and guides to ensure operational efficiency, compliance, and quality.• Developed and assisted with the implementation of the business plan for Quorum’s regulatory consulting division (Kinetiq) launched in 2016.• Managed consulting services provided to pharmaceutical, device, academic, foundation, and hospital clients. • Responded to inquiries from industry sponsors, contract research organizations, research sites, institutions, and other organizations regarding research-related matters.

Us

Responsibilities:• Advised and assisted with Medicare/Medicaid reimbursement, litigation, transactional, behavioral health, employment law, and general health law matters.

Doctor Of Law - Jd

Ba