OPEN RANK: Research Quality Improvement and Compliance Senior Analyst OR Specialist

The University of Maryland, Baltimore’s (UMB) Department of Physical Therapy and Rehabilitation Science (PTRS) within the School of Medicine has an exciting opportunity for a Research Quality Improvement and Compliance Senior Analyst or Specialist to join our team. The position will be filled as either a Analyst or Specialist dependent on selected candidate’s qualifications. 

The Senior Analyst/Specialist will report to the Administrator and will perform a variety of tasks to support the department’s research needs. This position will serve on the research administration team, supporting faculty, students and staff in the design, development, execution and oversight of research implementation processes which include the development of policy, identification and assessment of areas of research compliance risk and vulnerability.

PTRS currently offers degrees in Doctor of Physical Therapy (DPT), Doctor of Philosophy in Physical Rehabilitation Science (PhD), Dual DPT-PhD, Dual DPT-Master of Public Health (DPT-MPH). PTRS is dedicated to advancing the profession of rehabilitation through high-quality teaching, research, and excellence in clinical practice. Our faculty are nationally recognized for their extensive research.

BENEFITS (Exempt Regular):

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous paid leave package that includes over 4 weeks of vacation accrued each year, 15 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).

UMB is Ranked Among the Best Employers for Diversity by Forbes 2022 & 2023.

PRIMARY DUTIES – Senior Analyst, Research Quality Improvement & Compliance: 

• Execute and administer research implementation processes to include; applying policy, identifying and assessing areas of compliance risk and vulnerability and implementation of corrective actions. Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines. 
• Provides research regulatory and ethical requirements to researchers and research staff. Conduct mock monitoring reviews to facilitate education and training. Advise researchers about ethical standards and human subjects; conduct education and training programs for researchers; and provide communication regarding relevant research compliance issues and external audit information.
• Serve as a liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
• Prepare and provide basic information 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.
• Serve as a reviewer for a unit/school internal research review committee.
• Assist in the development and execution of internal quality management processes to ensure compliance with research requirements. Assist in identifying areas of risk and implementing corrective action plans. Facilitate resolution of regulatory 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. Provide information to researchers of changes and assist in devising strategies to successfully implement required updates.
• Develop, and maintain databases to store accurate and comprehensive records. Maintain attendance records and update/track education and training status in the program database for regulatory purposes.
• Develop reports to comply with appropriate regulations on research activities to management and other audiences.
• Work with specific Principal Investigators on specific, high impact funded projects within the department.
• Schedule quarterly faculty research meetings, create agenda and take meeting minutes.
• Assist with the planning and execution of the department’s annual Research Day.
• Performs other duties as assigned.
   

PRIMARY DUTIES – Specialist, Research Quality Improvement & Compliance: 

• Design, develop, execute and administer research implementation processes to include: applying policy, identifying and assessing areas of compliance risk and vulnerability and implementation of corrective actions. Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines.
• Consult and guide researchers and research staff on current research regulatory and ethical requirements. Develop and conduct training and education programs for department; Communicate relevant research compliance issues and external audit information.
• Facilitate new research studies, to include the informed consent, for Departmental and Institutional Review Board (IRB); process continuing reviews and amendments for IRB approved studies before submission deadlines; communicate with the IRB to resolve administrative modifications and address questions.
• Develop, execute and oversee an internal quality management processes to ensure compliance with research requirements. Identify areas of risk and implement corrective action plans. Facilitate resolution of regulatory 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. Provide information and recommendations to researchers of changes. Devise strategies to successfully implement required updates.
• Develop and maintain databases to store accurate and comprehensive records of research activities. Maintain attendance records and update/track IRB and FDA submissions in the program database for regulatory purposes.
• Develop and prepare reports to comply with appropriate regulations on research activities to management and other audiences.
• Provide information to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB.departmental information ensuring up-to-date faculty curriculum vitae’s (CV), current licensures, lab certifications, staff training certifications.
• Work with specific Principal Investigators on specific, high impact funded projects within the department.
• Schedule quarterly faculty research meetings, create agenda and take meeting minutes.
• Assist with the planning and execution of the department’s annual Research Day.
• Performs other duties as assigned.

 

Qualifications

  

MINIMUM QUALIFICATIONS – Senior Analyst, Research Quality Improvement & Compliance
Education: Bachelor’s degree in life science, healthcare administration, public health, policy, law or related field of the research. Master’s preferred.

Experience: Two (2) years of experience in clinical and/or laboratory research or related experience involving regulatory compliance issues.

Other: Related experience may be substituted for education.

MINIMUM QUALIFICATIONS – Specialist, Research Quality Improvement & Compliance
Education: Bachelor’s degree in life science, healthcare administration, public health, policy, law or related fields.

Experience: Three (3) years of experience in clinical and/or laboratory research projects or related experience involving regulatory compliance issues including two (2) years must be direct experience in administration of IRB, clinical trials, or research administration.

Other: Related experience may be substituted for education.

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to work in a fast-paced environment.
• Must possess strong organizational skills, time management and attention to detail.
• Ability to work on multiple projects concurrently.
• Skilled in effective use of technology tools and systems.
• Ability to communicate clearly and effectively, in a professional manner, both orally and in writing with a variety of people internal and external to the organization.

Hiring Range:  $64,000 – $68,000 per year for Senior Analyst/ $74,000 – $78,000 per year for Specialist (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 [email protected] . 

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 UMB Job Applicant Accommodation Request . You may also contact [email protected] . Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

 
Job
: Reg or CII Exempt Staff – E1454D
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift
: Day Job
Financial Disclosure: No
Organization
: School of Medicine – Physical Therapy
Job Posting
: Feb 29, 2024
Unposting Date
: Mar 14, 2024, 11:59:00 PM