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Manager, Research Quality Improvement & Compliance

Employer
University of Maryland, Baltimore
Location
Maryland, United States
Salary
Salary Commensurate with experience
Date posted
Aug 11, 2021

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Position Type
Administrative, Academic Affairs, Research Administration
Employment Level
Administrative
Employment Type
Full Time
The University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) seeks a Research Quality Improvement and Compliance Manager to oversee the evaluation of clinical research trials to ensure maximum protection of human subjects.  The Research Quality Improvement and Compliance Manager works closely with the Director of Clinical Research Operations to review monitoring/audit findings and discuss possible quality improvement initiatives to address concerns found. This position also coordinates and manages the monthly Data Safety Monitoring/Quality Assurance Committee and the bi-monthly Clinical Research Committee meetings. The Manager monitors and audits research-related operations to ensure compliance with laws, regulations, policies, procedures, ethical standards, and public responsibilities, in addition to providing education on audit findings to cancer center investigators and research personnel. Other duties as assigned. Flexible telecommuting options are available for this role.    UMB offers a comprehensive and competitive benefits package to eligible employees. This position receives an annual leave package starting with 22 accrued vacation days, 14 floating and observed holidays, 15 sick days, and 3 personal days; comprehensive health insurance and retirement options; professional learning and development opportunities; flexible schedules and teleworking options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.   In the Fall of 2021, UMB will require all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.   Primary Duties:
  • Manages one or more patient care, clinical research, or community outreach program(s) of substantive size and budget. Coordinates the daily activities and staff functions specific to that healthcare related program. Plans and coordinates daily activities of a health program, including developing protocols of service related to patient, subject, and community contact. Sets goals and creates tactics to achieve program objectives. Hires and trains staff as needed.
  • Manage daily activities of the Greenebaum Comprehensive Cancer Center (UMGCCC) research quality and compliance implementation processes, which include the development of policy, identification and assessment of areas of research compliance risk and vulnerability, and provision and implementation of recommendations to ensure appropriate corrective actions. Assesses the quality improvement processes for efficiency and recommends required process changes.  Oversee adherence with all international, federal, state and local regulations, laws, policies and guidelines.
  • Ensure delivery and tracking of research compliance education and training to researchers and research staff on the application and implementation of federal, state and international regulations, laws, guidelines, University policies and practices, ethical standards, responsible conduct of research and good clinical research practices for human subjects and animals.
  • Provide consultation and guidance on regulatory and ethical requirements in research to researchers and research staff. Develop procedure and conduct mock monitoring reviews to facilitate education and training. Advise researchers about ethical standards, human subjects and animal protection issues; conducting education and training programs for researchers; and developing and implementing a communication strategy regarding relevant research compliance issues and external audit information. Coordinates and assists in training programs for volunteers, professionals and/or the community.
  • Where the research component is present, collaborates with research staff to develop protocols and insure their timely implementation.  Evaluates program results and adjusts methods accordingly.  Provide guidance to researchers in protocol development, study conduct, regulatory binder preparation, clarification and documentation of study procedures, maintenance of study records, IRB submissions and modifications, conflict of interest, data security, and reporting requirements.
  • Coordinates and manages Data Safety Monitoring/Quality Assurance meetings.  Serve as a chair or co-chair for the unit’s internal research compliance review committees. Schedules monthly committee meetings and coordinates ad hoc reviews.
  • Assesses UMGCCC clinical research compliance with University and Federal laws, regulations and policies.  Manage the quality improvement and compliance program with research requirements, identify areas of risk, and implement corrective improvement action plans. Facilitate resolution of regulatory compliance issues as needed.
  • Research and remain abreast of federal, state, and local laws as well as University policy to identify changes regarding statutes and rulings that might affect research projects and compliance. Notify researchers of changes and devises strategies to successfully implement required updates.
  • Manage databases to store accurate and comprehensive records of research activities. Maintain attendance records, and update/track education and training status in the program database for regulatory purposes. Internally audits record keeping, data collection and management of clinical research records, to verify compliance with federal regulations and internal policies and procedures. Oversees record keeping, data collection, management, and analysis. Prepares and presents program reports.
  • Develop reports to comply with appropriate regulations. Provide routine and periodic reports on research improvement and compliance activities to management and other audiences. Generates and issues audit findings to UMGCCC leadership.
  • Provide direction and information to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB. Supervises, trains, schedules, and evaluates professional, research, clinic, and/or clerical staff.
  • Performs other duties as assigned.
  Qualifications    Education: Bachelor’s degree in nursing, life or social sciences, law or ethics, or related field. Master’s degree preferred.

Experience: Six (6) of experience in administration of IRB, clinical trials, research administration, or related experience involving regulatory compliance issues. Three (3) years must be direct experience in clinical and/or laboratory research projects

Supervisory Experience: One (1) year in work coordination, training, and daily oversight of staff, students, or volunteers.
 

Knowledge, Skills, and Abilities:

  • Thorough knowledge of position requirements. Thorough knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to support a mission and strategic vision. Instructional, training, and teambuilding skills to strengthen and cultivate relationships. Skill in consultation and change management. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Accountability, Civility, Collaboration, Diversity, Excellence, Leadership, and Knowledge.
  • Accomplishes responsibilities by primarily (>50%) performing significant managerial functions within area of responsibility. Possess subject matter expertise in a professional discipline. Achieves objectives through coordinated efforts of others, typically by managing recruitment, engagement, performance, and development of employees. Develops, implements, and manages goals and objectives. Participates in strategic planning. Determines and enforces processes, practices, and/or policies. Manages operations, workflow, projects, and/or systems that have strategic impact. Accountable for operational and/or financial resources. Accountable for legal and policy compliance.
  • Manages the daily operations, typically, of a work unit (group(s) or team(s) of staff who perform similar type work) or function (division(s), program(s), or specialized unit(s) within a department). Develops and achieves broadly stated goals and objectives in alignment with defined strategy. Primarily responsible for overall execution of results. Wide latitude to make managerial decisions within area of responsibility. Recommends financial, personnel, and significant strategic decisions for upper senior professional approval.
Hiring Range: Commensurate with education and experience.

UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy. For assistance related to employment, please contact the Staffing department at HRJobs@umaryland.edu.

If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a https://umbforms.wufoo.com/forms/umb-job-applicant-accommodation-request/" href="https://umbforms.wufoo.com/forms/umb-job-applicant-accommodation-request/" target="_blank">UMB Job Applicant Accommodation Request. You may also contact HRDiversity@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

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