Harvard Pilgrim Health Care Institute (the "Institute") is currently seeking highly motivated individuals to join our organization as Research Compliance Specialist – Quality Assurance/Quality Improvement ("QA/QI").
The Research Compliance Specialist – QA/QI is responsible for implementing auditing/monitoring and accreditation projects to help ensure the Institute complies with state and federal requirements, policies and procedures, and accreditation standards related to the non-fiscal component of human subjects research performed on behalf of Harvard Pilgrim Health Care, Inc. ("HPHC").
The Research Compliance Specialist – QA/QI is responsible for providing the day-to-day QA/QI compliance function, including legal analysis, evaluation and monitoring of research operational areas for compliance with legal requirements. S/he translates complex legal requirements and makes decisions on their application to research activities.
WHAT YOU WILL BE DOING:
- Retrieving and analyzing federal and state regulations, statutes, and enforcement activities and providing guidance regarding legal and accreditation standards (e.g. AAHRPP, FDA, OHRP, ORI, etc.), including, but not limited to human subjects research, scientific integrity, conflicts of interest, export controls and intellectual property.
- Serving as anchor member of the accreditation team; developing checklists, templates, metrics, databases and other tools; and developing and implementing risk assessments, operational audits and training programs.
- Drafting, reviewing and revising correspondence, policies and procedures, reports and other materials to meet the goals and objectives of the Institute's research compliance work plan.
- Performing out-of-the-box thinking, collaborating with others, and making a difference every day!
- Other duties and projects as assigned.
WHAT YOU NEED:
- Juris Doctorate degree, Master's degree, or at minimum Bachelor's degree with at least five years' experience in a position requiring ability to locate legal citations, analyze federal and state statutes and regulations, and provide guidance.
- Experience in audit, compliance, legal, or regulatory function in a research organization, health care organization and/or regulatory environment strongly preferred.
- Strong database management and computer technology skills with proficiency in Microsoft Office (Outlook, Word, Excel, Access, and PowerPoint), Adobe Pro, and Internet research.
- Ability to be resilient, collaborative, flexible and innovative.
WHAT MAKES US STAND OUT:
• Paid volunteer time off (up to 3 days annually)
• Open Time Off (include for exempt positions only)
• Annual Mini-Grant of $500 donated to a non-profit organization of the employee's choice
• Educational Reimbursement