Clinical Research Senior Assistant OR Specialist

About the role

The Bone Marrow Transplant and Cellular Therapy (BMT-CT) research team within the Clinical Research Management Office of the University of Maryland, Baltimore School of Medicine, Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is currently recruiting for a full-time Bone Marrow Senior Clinical Research Assistant or Clinical Research Specialist.

Responsibilities

• Facilitate and coordinate clinical research patient visits and data collection.
• Support 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.
• Aid 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.
• Coordinate data collection of the research study including obtaining medical records, lab results, diagnostic results, visit notes, etc.
• Coordinate recruitment and screening subjects for research studies according to IRB approved protocols. May communicate directly with study participants.
• Coordinate paperwork for submission of IRB protocol, IRB amendments, and IRB continuing reviews. Document and report all adverse events as appropriate.
• Participate in audits and monitor visits as needed according to policy.
• Perform the coordination of data analysis and interpretation, and develop statistical reports of study data using SAS, STATA, and SPSS software.
• Assist in the development, submission, and provision of content for grants, papers, abstracts, manuscripts, and presentations.
• Conduct and analyze literature searches.
• Develop and establish a database to track research data.
• Coordinate development of research protocols and materials by providing study analysis and forming conclusions and recommendations.
• Maintain communication with participants and colleagues regarding protocol specific information and research orders. Provide assessments and ensure protocol compliance while participants are in a study.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree in a scientific field of study related to the research of the clinical setting.
• Two (2) years of experience in clinical research in research being performed in unit. Prior experience with patients and patient interaction preferred.

Skills

• 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.
• Ability to represent the Cancer Center and its faculty in a professional manner.
• Ability to keep patient information confidential and possess knowledge of HIPPA regulations.