The University of Maryland, Baltimore (UMB) Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has full-time openings for 2 Senior Clinical Research Assistants. This position is the primary interface, along with the faculty member for cancer patients enrolled in clinical trials. This position is responsible for screening, enrolling and consenting the patients and subsequently guiding 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.
UMB offers a comprehensive and competitive benefits package to eligible employees. This is a contractual position that offers a generous leave package of 10 vacation days, 3 personal days, 8 holidays, and 5 sick days; comprehensive health insurance and supplemental retirement options; professional learning and development opportunities; and limited tuition remission for employees enrolled at UMB.
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.
- Responsible for facilitating and coordinating clinical research patient visits and data collection. Supports the conduct of clinical trials, including the coordination of start-up activities, scheduling and preparing for patient visits, assisting with data collection and clarification, and general administrative duties.
- Assists in the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. May assist in developing and recommending policies and procedures and/or design methods for clinical research activities.
- Coordinates data collection of the research study including obtaining medical records, lab results, diagnostic results, visit notes, etc. Coordinates recruitment and screening subjects for research studies according to IRB approved protocols. May communicate directly with study participants.
- Coordinates paperwork for submission of IRB protocol, IRB amendments, and IRB continuing reviews. Document and report all adverse events as appropriate. Participates in audits and monitor visits as needed according to policy.
- Performs the coordination of data analysis and interpretation, and develops statistical reports of study data using descriptive statistics using SAS, STATA, and SPSSS software. Assists in developing, submitting, and providing content for grants, papers, abstracts, manuscripts, and presentations. Conducts and analyzes literature searches. Develops and establishes a database to track research data.
- Coordinates development of research protocols and materials by providing study analysis and forming conclusions and recommendations.
- Documents in accordance with state and federal standards pertaining to specific research participant enrolled in the study. 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.
- Performs other duties as assigned.
Education: Bachelor’s degree.
Experience: Two (2) years of experience in clinical research.
May consider a combination of directly related experience and education.
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. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Accountability, Civility, Collaboration, Diversity, Excellence, Leadership, and Knowledge.
Hiring Range: 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.