Biotech & Pharma E-3 Sponsorship Jobs in New York

INTRODUCTION

Reporting to the Director of Research Security, the Quality Assurance and Improvement (QA/QI) Specialist provides support to the University at Albany's Office of Regulatory and Research Compliance (ORRC) in the areas of Quality Assurance, Quality Improvement, and Internal Controls to support responsible, ethical, and secure conduct of research.

Description of Duties:

The QA/QI Specialist supports institutional compliance in the areas across Research Security and Research Protections.

• The Specialist will support the assurance and improvement of activities and controls related to: data use agreements, international collaboration assessments, export controls, conflicts of interest management, human subjects, animal welfare, and tracking of personnel trainings.
• The position is responsible for conducting systematic QA/QI reviews to evaluate adherence to federal regulations, institutional policies, and sponsor-specific obligations. The Specialist identifies potential gaps in protocol compliance, documentation, training, and data security practices, and will work with the Director to develop targeted plans to strengthen the integrity of research and reduce regulatory risk.
• Core responsibilities include monitoring research security activities by reviewing researcher and institutional compliance with policies, procedures, data management plans, technology control plans, conflicts-of-interest management, secure storage environments, access controls, and compliance with agreements, export control considerations, and federal research security directives.
• The QA/QI Specialist will work directly with the Director, researchers, and Information Technology Services (ITS) to test and document compliance.
• The role will ensure that sensitive, identifiable, or controlled research data are managed within approved secure systems and that investigators follow institutional safeguards for high-risk data.
• The Specialist also works with the Director of Research Protections to track policy and procedures verifying that participant rights, welfare, and confidentiality are safeguarded. The QA/QI specialist will also review consent processes, data handling, and study procedures to assess alignment with approved protocols and institutional procedures on an as needed basis.
• The QA/QI Specialist collaborates with the ORRC team, researchers, compliance committees, and institutional leadership to support internal and external audits and inspections. The QA/QI Specialist will also promote continuous improvement across all research compliance domains.
• This position plays a critical role in maintaining institutional accountability, reducing noncompliance, and ensuring ethical and secure conduct of research.

MINIMUM QUALIFICATIONS

• Bachelor's degree from an accredited institution; Four (4) years of relevant professional experience may substitute for a Bachelor's degree; two (2) years with an Associate's degree may substitute.
• Professional experience involving interpretation, analysis, application, review, or writing of regulations, laws, or policies.
• Three (3) or more years of professional experience that include reviewing procedures and processes, ensuring the accuracy and completeness of work, and identifying potential improvements.
• Strong organizational skills with the ability to prioritize multiple tasks and meet deadlines in a fast-paced environment.
• Excellent oral and written communication skills and the ability to interact effectively with faculty, staff, and students.
• Demonstrated ability to provide high-quality administrative and compliance support to facilitate ethical and efficient research review processes.
• Experience using contemporary technologies and software to complete office work, including but not limited to experience using database systems and managing electronic-based compliance information.
• Demonstrated success working in a team-based professional setting and engaging with diverse constituent groups.
• Due to U.S. Export Control laws and regulations, the candidate hired will need to be a U.S. citizen, lawful permanent resident, or other "protected individual" as defined by 8 U.S.C. Sec. 1324b(a)(3).

PREFERRED QUALIFICATIONS

• Master's degree in public policy, law, research ethics, risk management, or a related field.
• More than 3 years of professional experience in the above-mentioned activities.
• Experience working in a research-intensive institution of higher education, particularly within compliance or research administration.
• Experience carrying out any of the following in a professional capacity: Investigations, Risk Assessment, Direct responsibility for the conduct of research.
• Experience interpreting or implementing federal, state, or institutional regulations related to research (e.g., IRB, IACUC, privacy regulations, export controls, research security).
• Prior training or certifications in human subjects research, animal research compliance, export control, auditing, internal controls, corporate compliance, research security, or related regulatory areas.

SALARY RANGE

• Salary Range: $75,000-$80,000 (DOE)

Additional Information

Subject to change: This position may be eligible for up to 60% alternative workplace arrangement (Hybrid) with supervisor approval with in-person requirement located in Albany, New York.

Federal law and regulations require notice to all prospective employees regarding crimes that have occurred on campus in the current three-year period. Please refer to the following website for the complete Annual Security Report ("Clery Report"): http://police.albany.edu/ASR.shtml

As an Equal Opportunity/Affirmative Action Employer, The Research Foundation for SUNY will not discriminate in its employment practices due to an applicant's race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity or expression, transgender status, age, national origin, marital status, citizenship, physical and mental disability, criminal record, genetic information, predisposition or carrier status, status with respect to receiving public assistance, domestic violence victim status, a disabled, special, recently separated, active duty wartime, campaign badge, Armed Forces service medal veteran, or any other characteristics protected under applicable law.

The Research Foundation for The State University of New York offers exceptional benefits such as healthcare, dental, vision, pension plans, competitive pay, generous paid time off, tuition assistance, life insurance and long-term disability insurance. The University at Albany offers a variety of performing arts, world class libraries, and competitive sporting events.