Lead Research Quality Improvement & Compliance Specialist

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

Benefits offered by this job

Health insurance

PAID leave package (4+ weeks)

Tuition remission

Flexible work schedules

Job summary

The University of Maryland, Baltimore (UMB) seeks a Lead Research Quality Improvement & Compliance Specialist in the School of Medicine, Department of Radiation Oncology. This role develops and administers research processes, ensures regulatory compliance, and provides education on federal, state, and international regulations to researchers and staff.

Requires advanced knowledge of research compliance, IRB processes, and program leadership.

Qualifications

• Four years of experience in clinical and/or laboratory research with regulatory compliance.
• Experience administering IRB, clinical trials, or research administration.
• Bachelor's degree required; Master's preferred.
• Supervisory experience managing staff for at least one year.
• Preferred: GLP laboratory experience and QC of study documentation.

Responsibilities

• Lead the design, development, execution, and administration of research processes and programs; ensure compliance with regulations.
• Identify education and training needs and deliver training to researchers and staff on regulations and ethical standards.
• Provide guidance on regulatory and ethical requirements to researchers; lead education programs and communicate compliance issues.
• Lead new research studies including IRB review in electronic systems.
• Process continuing reviews and amendments for IRB approved studies; liaise with IRB.

Skills

Effective communication

Teamwork

Regulatory knowledge

Technical proficiency

Education

Bachelor's degree in nursing or related field

Master's degree preferred

Tools

Quality document management software

Job description

The University of Maryland, Baltimore (UMB) is currently seekinga Lead Research Quality Improvement & Compliance Specialist tojoin their team in the School of Medicine - Department of RadiationOncology.

SCOPE OF ROLE

Accomplishes responsibilities by applying specialized andtheoretical knowledge, principles, and concepts of a professionaldiscipline normally acquired through advanced education orspecialized training. Resolves issues and significant matters onbehalf of management by utilizing independent judgment, discretion,creativity, and analytical thinking. Contributes to development andevaluation of goals and objectives. Creates solutions to ensurelegal and policy compliance. May supervise, mentor, or coordinatework of others (positions that supervise are responsible forservice delivery, quality assurance, and employee performance). Mayindependently 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. Informssupervisor of progress. Works on ambiguous matters generallywithout precedent or structure and independently developsstandardization and protocol. Makes departures from traditionalapproaches to develop novel solutions. Influences strategy,program, policy development, and best practices. Acts as expertresource to others.

BENEFITS (Exempt Regular):

UMB offers a comprehensive benefits package thatprioritizes wellness, work/life balance, and professionaldevelopment, along with additional exciting perks that employees can take advantage of. This position participates ina retirement program (pension or optional retirement plan/ORP) thatmust be selected and is effective on your date of hire. Exemptregular staff receive a generous PAID leave package that includesover 4 weeks of vacation accrued each year, 16 paid holidays, 3personal leave days, unlimited accrual of sick time, andcomprehensive health insurance; professional learning anddevelopment programs; tuition remission for employees and theirdependents at any University System of Maryland school; andflexible work schedules and teleworking options (if applicable perjob).

UMB is a public university and constituent institution of theUniversity System of Maryland. All employees are expected to workprimarily physically within the State of Maryland.

PRIMARY DUTIES

• Lead the design, development, execution, and administration ofresearch process. Oversee research processes by identification, andassessment of areas of research compliance risk and vulnerability;provide recommendations and ensure appropriate corrective actionsare implemented; and the development of policy, Ensure adherencewith all international, federal, state and local regulations, laws,policies and guidelines.
• Identify education and training needs and develop, and delivereducation and training to researchers and research staff on theapplication and implementation of federal, state and internationalregulations, laws, guidelines, University policies and practices,ethical standards, responsible conduct of research and goodclinical research practices for human subjects and animals.Identifies needs for future training and develops trainingmaterials.
• Provide consultation and guidance on basic and complex researchregulatory and ethical requirements to researchers and researchstaff. May lead mock monitoring reviews to facilitate education andtraining. Advise researchers about routine and complex ethicalstandards, human subjects and animal protection issues; develop andconduct education and training programs for researchers; andidentify, develop, and implement a communication strategy regardingrelevant research compliance issues and external auditinformation.
• Leads new research studies, to include the informed consent,for Departmental and Institutional Review Board (IRB) review in theIRB's electronic system.
• Process continuing reviews and amendments for IRB approvedstudies before submission deadlines. Communicates with theInstitutional Review Board (IRB) to resolve administrativemodifications and address queries.
• Lead new protocols for FDA and IND submissions. Prepare theprotocol and informed consent form for PI-initiated researchstudies and final PI approval.
• Provide subject matter expertise to researchers on basic and complex protocol development, study conduct, regulatory binderpreparation, clarification and documentation of study procedures,maintenance of study records, IRB submissions and modifications,conflict of interest, data security, and reportingrequirements.
• Facilitate unit/school internal research review committees andleads the review process. Leads recommendations for processimprovement to ensure implementation is completed
• Develop, execute, and oversee an internal quality managementprogram and the processes to facilitate compliance with researchrequirements, identify areas of risk, and implement correctiveaction plans. Facilitate resolution of regulatory issues asneeded.
• Research and remain abreast of federal, state, and local lawsas well as University policy to identify changes regarding statutesand rulings that might affect research projects and compliance.Notify researchers of changes and devises strategies tosuccessfully implement required updates. Develop communication toapprise and educate on the changes.
• Conceptualize, develop, and maintain databases to storeaccurate and comprehensive records of research activities. Maintainattendance records and update/track IRB, FDA, and IND submissionsin the program database for regulatory purposes.
• Serve as the Administrator for clinical trials. Report data ofqualifying studies to federal agencies as assigned by PI.
• Facilitates the registry and reporting of qualifying clinicalresearch studies and data to specified agencies.
• Develop reports to comply with appropriate regulations. Provideroutine and periodic reports on research activities to managementand other audiences.
• Develop and provide communication to internal campus andexternal stakeholders in connection with research complianceregulations, laws, guidelines, policies, and processes at UMB.
• Performs other duties as assigned.

Qualifications :

MINIMUM QUALIFICATIONS

Education:

Bachelors in nursing, life science, healthcareadministration, public health, policy, law or related field of theresearch. Master's preferred.

Experience:

Four (4) years of experience in clinical and/orlaboratory research projects or related experience involvingregulatory compliance issues including three (3) years of directexperience in administration of IRB, clinical trials, or researchadministration

Supervisory Experience:

One year of work coordination ofstaff.

Other:

Except for qualifications established by law,additional related experience and formal education in which one hasgained the knowledge, skills, and abilities required for fullperformance of the work of the job class may be substituted for theeducation or experience requirement on a year-for-year basis with30 undergraduate college credits being equivalent to one year ofrelated experience. In instances where specific education and/orexperience is required only directly related education and/orexperience may be substituted.

Preferred qualifications:

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

KNOWLEDGE, SKILLS, ABILITIES

Knowledge of position requirements. Knowledge of all applicablerequirements, regulations, and laws. Skill in effective use ofapplicable technology/systems. Ability to effectively communicateboth verbal and written thoughts, ideas, and facts. Ability to workcooperatively with others and independently. Ability todemonstrate, understand, apply, and adhere to the UMB Core Valuesof Respect and Integrity, Well-being and Sustainability, Equity andJustice, and Innovation and Discovery.

HIRING RANGE:

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

UMB is committed to cultivating a diverse and inclusive workforceand is proud to be an equal employment opportunity employer. Allqualified applicants will receive consideration for employmentwithout regard to race, color, religion, age, ancestry or nationalorigin, sex, pregnancy or related conditions, sexual orientation,gender identity or expression, genetic information, physical ormental disability, marital status, protected veteran's status, orany other legally protected classification.

If you anticipate needing a reasonable accommodation for adisability under the Americans With Disabilities Act (ADA), duringany 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 forreasonable accommodation will be responded to from this emailaddress.

The University of Maryland, Baltimore prohibits sex discriminationin 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.