Research Quality Improvement and Compliance Specialist

3 weeks ago

Baltimore, United States University of Maryland, Batlimore Full time

The University of Maryland, Baltimore Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking a full-time, exempt Research Quality Improvement and Compliance Specialist within the Clinical Research Management Office. The Specialist is responsible for the management of all regulatory and compliance matters related to a caseload of clinical trials across multiple oncology disease areas and faculty. The incumbent in this position provides guidance to the UMGCCC Clinical Research Management Office staff in matters of human research protection laws, regulations, policies, procedures, and ethical standards.

This position permits a fully remote work schedule with on campus meetings as needed but not to exceed once per quarter.

The Cancer Center will provide training for and access to the Electronic Regulatory system utilized within the Clinical Research Management Office as well as equipment necessary to perform the job, such as computers, printers, cables, and/or other software as needed pursuant to the UMB Policy on Telework.

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.

Primary Duties

* Design, develop, execute, and administer research implementation processes which include the identification and assessment of areas of research compliance risk and vulnerability; and implementation of recommendations to ensure appropriate corrective actions; and implementation of policy, 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. May conduct training and mock reviews to facilitate education and training. Advise researchers about ethical standards, human subjects and animal protection issues; develop and conduct education and training programs for researchers; and identify, develop, and implement communication strategies regarding relevant research compliance issues and external audit information.
* Facilitates 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.
* Facilitate and complete new protocols for FDA and IND submissions. May assist principal investigators in preparing the protocol and informed consent form for PI-initiated research studies.
* Provide advance knowledge-based information to researchers in basic and complex protocol development, study conduct, 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.
* Develop, execute and oversee 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. Provides information and recommendations to researchers of changes. Devises 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.
* Performs other duties as assigned.

Education: Bachelor's degree in nursing, life science, healthcare administration, public health, policy, law or related field of the research. Master's degree preferred.

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

Certification/Licensure: Society of Clinical Research Associates (SOCRA) certification preferred.

Other: Related experience may be substituted for education.

Knowledge, Skills, and Abilities

* Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
* Ability to perform independent projects.
* Ability to network with and provide information to key groups and individuals, and work as part of a team.
* Knowledge of human subject research including the regulations and policies surrounding it.
* Prior experience with patients and patient interaction preferred.
* Ability to represent the Cancer Center and its faculty in a professional manner.
* Ability to keep patient information confidential. Knowledge of HIPPA regulations.

The Hiring Range for this position is in the $70,000s, 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 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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