Lead Research Quality Improvement & Compliance Specialist

University of Maryland, Baltimore (UMB); Baltimore (MD); On-site; USD 84,000 - 95,000; Full time

Benefits offered by this job

Tuition remission for employees and/or

Flexible work schedules

Teleworking options

Paid leave package

Job summary

University of Maryland, Baltimore (UMB) seeks a Lead Research Quality Improvement & Compliance Specialist in the School of Medicine, Department of Radiation Oncology, to oversee research processes and regulatory compliance across IRB, FDA/IND submissions, and related activities.

The role requires advanced knowledge of research regulations, training researchers, and implementing quality management programs with strong leadership and communication skills.

Qualifications

• Bachelor's degree in nursing, life science, healthcare administration, public health, policy, or related field.
• Master's degree preferred.
• Four years of experience in clinical and/or laboratory research with regulatory compliance.
• Three years of direct experience in IRB, clinical trials, or research administration.
• One year of supervisory experience.

Responsibilities

• Lead the design, development, execution, and administration of the research process.
• Identify education and training needs and deliver training to researchers on regulations and ethical standards.
• Provide consultation on regulatory and ethical requirements to researchers and staff.
• Lead new protocols for FDA and IND submissions and prepare consent forms.
• Develop and oversee an internal quality management program for compliance and risk.
• Develop reports and communications for management and stakeholders.

Skills

Regulatory knowledge

Analytical thinking

Effective communication

Policy interpretation

Project coordination

Education

Bachelor's degree in nursing, life science, healthcare administration, public health, policy, or related field

Master's degree preferred

Tools

Quality document management software

Job description

The University of Maryland, Baltimore (UMB) is currently seeking a Lead Research Quality Improvement & Compliance Specialist to join their team in the School of Medicine - Department of Radiation Oncology.

SCOPE OF ROLE

Accomplishes responsibilities by applying specialized and theoretical knowledge, principles, and concepts of a professional discipline normally acquired through advanced education or specialized training. Resolves issues and significant matters on behalf of management by utilizing independent judgment, discretion, creativity, and analytical thinking. Contributes to development and evaluation of goals and objectives. Creates solutions to ensure legal and policy compliance. May supervise, mentor, or coordinate work of others (positions that supervise are responsible for service delivery, quality assurance, and employee performance). May independently manage or administer programs, processes, projects, or resources. Applies advanced, expert level knowledge, concepts, principles, and skills. Substantial latitude in decision making. Sets goals and objectives to align with defined strategy. Informs supervisor of progress. Works on ambiguous matters generally without precedent or structure and independently develops standardization and protocol. Makes departures from traditional approaches to develop novel solutions. Influences strategy, program, policy development, and best practices. Acts as expert resource to others.

BENEFITS (Exempt Regular)

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. 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, 16 paid holidays, 3 personal leave days, 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 a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.

Primary Duties

• Lead the design, development, execution, and administration of research process. Oversee research processes by identification, and assessment of areas of research compliance risk and vulnerability; provide recommendations and ensure appropriate corrective actions are implemented; and the development of policy, Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines.
• Identify education and training needs and develop, and deliver 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. Identifies needs for future training and develops training materials.
• Provide consultation and guidance on basic and complex research regulatory and ethical requirements to researchers and research staff. May lead mock monitoring reviews to facilitate education and training. Advise researchers about routine and complex ethical standards, human subjects and animal protection issues; develop and conduct education and training programs for researchers; and identify, develop, and implement a communication strategy regarding relevant research compliance issues and external audit information.
• Leads new research studies, to include the informed consent, for Departmental and Institutional Review Board (IRB) review in the IRB's electronic system.
• Process continuing reviews and amendments for IRB approved studies before submission deadlines. Communicates with the Institutional Review Board (IRB) to resolve administrative modifications and address queries.
• Lead new protocols for FDA and IND submissions. Prepare the protocol and informed consent form for PI-initiated research studies and final PI approval.
• Provide subject matter expertise to researchers on basic and complex 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.
• Facilitate unit/school internal research review committees and leads the review process. Leads recommendations for process improvement to ensure implementation is completed
• Develop, execute, and oversee an internal quality management program and the processes to facilitate 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. Notify researchers of changes and devises strategies to successfully implement required updates. Develop communication to apprise and educate on the changes.
• Conceptualize, develop, and maintain databases to store accurate and comprehensive records of research activities. Maintain attendance records and update/track IRB, FDA, and IND submissions in the program database for regulatory purposes.
• Serve as the Administrator for clinical trials. Report data of qualifying studies to federal agencies as assigned by PI.
• Facilitates the registry and reporting of qualifying clinical research studies and data to specified agencies.
• Develop reports to comply with appropriate regulations. Provide routine and periodic reports on research activities to management and other audiences.
• Develop and provide communication to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB.
• Performs other duties as assigned.

Minimum Qualifications

• Education: Bachelors in nursing, life science, healthcare administration, public health, policy, law or related field of the research. Master's preferred.
• Experience: Four (4) years of experience in clinical and/or laboratory research projects or related experience involving regulatory compliance issues including three (3) years of direct experience in administration of IRB, clinical trials, or research administration.
• Supervisory Experience: One year of work coordination of staff.
• Other: Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted.

Preferred Qualifications

• Minimum 2 years’ experience in a GLP laboratory supporting laboratory animal research.
• Experience performing quality control (QC) review of study documentation and data, including raw data, study records, protocols, amendments, reports, and supporting documentation, and training others on QC procedures.
• Experience using quality document management software.
• Experience performing project management activities, including progress reporting, agenda/meeting minute preparation and coordination of study activities.

Knowledge, Skills, Abilities

Knowledge of position requirements. 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 work cooperatively with others and independently. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

HIRING RANGE:

$84,000 - $95,000 per year / Commensurate with education and experience

UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.

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 [e-mail]. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.