Specialist, Clinical Trial Protocol Development - (210001F6)
The University of Maryland, Baltimore (UMB) Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is now hiring a Clinical Trial Protocol Development Specialist to join the Clinical Research Office. This position will be responsible for the development of investigator-initiated clinical trial studies, ensuring compliance with departmental and Institutional Review Board (IRB) requirements including oversight of documentation (e.g. IRB documents, informed consent documents, single-patient Investigational New Drug (IND), emergency use, expanded access, and Investigational Device Exemption (IDE) applications).
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; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
UMB requires all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.
Assist in the development of investigator-initiated studies. Assists with the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial.
Ensure compliance with the cancer center and IRB requirements; documentation, (e.g. IRB documents, informed consent documents, single-patient IND, Emergency use, expanded access, and IDE applications); training of staff for implementation of research protocols using a variety of complex activities.
Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
Oversees day to day clinical research operations and leads study initiation, execution, and completion. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
Performs day-to-day operational duties such as: ensuring quality control and safety compliance; serving as liaison with IRB; submitting invoicing; developing procedures; ordering supplies.
Performs other related duties as assigned.
Education : Bachelor's degree in epidemiology, sociology, psychology, nursing or field of study related to the research of the clinic.
Experience : Three (3) years of experience in a clinical research setting.
Certification/Licensure : SOCRA certification desirable but not required.
Other : May consider a combination of directly related experience and education
Required 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 subjects research, the regulations and policies surrounding it.
Prior experience with patients and patient interaction.
Ability to represent the Cancer Center and its faculty in a professional manner.
Ability to keep patient information confidential, knowledge of HIPPA regulations.
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 Accountability, Civility, Collaboration, Diversity, Excellence, Leadership, and Knowledge.
Hiring Range: Approximately $60,000 - $70,000, commensurate with related 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.
Job: Reg or CII Exempt Staff - E3342E
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Organization: School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.