The University of Maryland, Baltimore School of Medicine, Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is currently recruiting for a full-time, contractual Clinical Research Lead Specialist. This position is the primary interface, along with the faculty member, for cancer patients enrolled in clinical trials. The Lead Specialist screens, enrolls and consents the patients and subsequently guides the patient through the research protocol, their courses of care/medication, research visits, data collection, standard of care issues and direct research support. This position works directly with the medical care team, ancillary hospital staff, the Sponsor, and data managers in the Cancer Center.
The University of Maryland, Baltimore offers a comprehensive and competitive benefits package to eligible employees. This is a contractual position that offers a generous leave package that includes 10 vacation days, 11 personal and holidays, 5 sick days; comprehensive health insurance and supplemental retirement options; and limited tuition remission for employees enrolled at UMB.
In the Fall of 2021, UMB will require all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.
Leads the highest technical research and guides research programs, projects, and activities in a clinical setting. Responsible for ensuring design, development, documentation and implementation of research procedures and protocols using a variety of complex activities. Networks with faculty and staff to achieve strategic goals and maximize efficiency.
Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards. Prepares for the Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities.
Leads the management and analysis of clinical research data to include data analysis using statistical software, data collection, data entry, data verification, and ensure compliance and clinical relevance of data. Assists in the development and implementation of site tracking tools to comply with data monitoring requirements per federal regulations and guidance. Independently cleans, validates, and analyzes research data in order to prepare research findings for publications of journal articles and grant proposals.
Leads the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
Performs advanced clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data. May develop data collection instruments such as survey questionnaires.
Maintains communication with participants and colleagues regarding protocol specific information and research orders. Provides assessments and ensure protocol compliance while participants are in a study.
Serves as liaison to other departments such as IRB or UMB's Center for Clinical Trials and Corporate Contracts (CCT), outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.
Oversees the management of day to day clinical research operations and leads study initiation, execution, and completion. Assist in the design and provide expert recommendation regarding research studies. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
Provides working coordination and feedback to others.
Performs day-to-day operational duties such as: monitoring the budget; budget negotiation and review, ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develops policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.
Searches relevant literature, develops conclusions, writes reports, prepares, and delivers presentations of relevant findings and conclusions, and recommends appropriate actions. Reviews analysis and reports of less experience members of the research team.
Trains and provides mentoring to other research personnel in implementation of research protocols, IRB submissions, research procedures and policies, etc. Serves as subject matter expert and provides guidance for staff, faculty, and leadership. Develops protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals, institutions, government agencies, and funding agencies; and participating in the design of research studies.
Performs other duties as assigned.
Education: Bachelor's degree in scientific field of study related to the research of the clinic.
Experience: Five (5) years clinical research including three (3) years in the relevant research specialization.
Other: Master's degree in related field may be substituted for two (2) years of related experience.
Knowledge, Skills, and 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.
Hiring Range: Mid-$70,000s to mid-$80,000s, 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.
Job: Reg or CII Exempt Staff - E3324F
Employee Class Exempt Contingent II
Full Time/Part Time: Full-Time
Shift: Day Job
Organization: School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center
Job Posting: Apr 21, 2021
Unposting Date: May 27, 2021, 3:59:00 AM
Internal Number: 171341
About University of Maryland, Baltimore
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.