Research Specialist, Clinical - SOM Oncology Program

Job Description

The University of Maryland, Baltimore (UMB) Marlene &
Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has an
exciting opportunity for a full-time Clinical Research Specialist
for the Hematologic Malignancies research program. Following an
extensive training program, the Clinical Research Specialist will
be assigned a portfolio of cutting-edge novel therapeutic trials
and will be the primary interface, along with the faculty member,
for cancer patients enrolled in the studies. The Clinical Research
Specialist will be responsible for screening, consenting, and
enrolling patients as well s consequently guiding them through
procedures and visits required by the research protocol. The
Research Specialist is also responsible for data collection,
resolving standard of care issues and direct research support. The
Clinical Research Specialist will interface directly with the
Principal Investigators on the protocols within their assigned
portfolio as well as the medical care team, ancillary hospital
staff, Sponsor representatives, and data managers within UMGCCC.
This full-time position works Monday through Friday and may
require scheduling flexibility that includes working outside of
normal working hours.

UMB is a public university and constituent institution of the
University System of Maryland. All employees are expected to work
primarily physically within the State of Maryland.

Responsibilities

Primary Duties

• Performs as a single Specialist in a clinical setting who is

responsible for providing technical expertise to research programs
and projects overseeing clinical research activities. The position
develops, recommends, modifies, and implements policies and
procedures for clinical research, as well as develop protocol
manuals and data collection instruments. This position
significantly contributes to the conduct of research.

• Coordinates 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. Coordinates developing and recommending policies
and procedures and/or design methods for clinical research
activities.

• Manages interaction with subject participants including

eligibility screening, recruitment, enrollment, ensuring informed
consent is properly secured and documented, counseling, and
obtaining patient medical history. May obtain tissue and blood
samples as necessary and collects information through interviews,
questionnaires, test results, and charts.

• Establishes and maintains database files and reports using

computer applications such as Microsoft Excel/Access. Perform data
checks, audits, and data cleaning. Check validity and accuracy of
data ensuring compliance with quality control requirements and
study relevance.

• Performs 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 CCT,

outside organizations, government agencies, and product
representatives to promote effective and efficient operation and
use of resources.

• Oversees and coordinates the day-to-day clinical research

operations, 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.

• May provide 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 on research

findings, writes reports, prepare and deliver presentations of
relevant findings and conclusions, and recommends appropriate
actions. May conduct library research and contributes to the
preparation and writing of research findings for publication of
journal articles and grant proposals.

• Provides training to less experienced researchers; assisting in

developing and submitting grants, papers, abstracts, manuscripts
and presenting studies; developing 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.

Qualifications

Education: Bachelor's degree in a scientific field of study
related to the research of the clinical setting.

Experience: Three (3) years of clinical research including
two (2) years in the relevant research specialization.

Other: Except for qualifications established by law,
additional related experience and formal education in which one has
gained the knowledge, skills, and abilities required for full
performance of the work of the job class may be substituted for the
education or experience requirement on a year-for-year basis with
30 undergraduate college credits being equivalent to one year of
related experience. In instances where specific education and/or
experience is required only directly related education and/or
experience may be substituted. Some schedule flexibility may be
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 and possess

knowledge of HIPPA regulations.

About Us

The University of Maryland, Baltimore (UMB) is Maryland’s public
health, law, and human services university. Six professional
schools and the interdisciplinary Graduate School confer the
majority of health care, human services, and law professional
degrees in Maryland each year.

Our goal is to support the University’s mission of education,
research, clinical care, and public service by amplifying UMB’s
voice as a thought and action leader, and to enhance goodwill in
the communities and people with whom we engage. UMB is a public
university and constituent institution of the University System of
Maryland. All employees are expected to work primarily physically
within the State of Maryland.

UMB is committed to cultivating a diverse and inclusive workforce
and is proud to be an equal employment opportunity employer. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, age, ancestry or national
origin, sex, pregnancy or related conditions, sexual orientation,
gender identity or expression, genetic information, physical or
mental disability, marital status, protected veteran's status, or
any other legally protected classification.

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.

The University of Maryland, Baltimore prohibits sex discrimination
in any education program or activity that it operates. Individuals
may report concerns or questions to the Title IX Coordinator. Read
the UMB Notice of Non-Discrimination for more
information.

UMB is a public university and constituent institution of the
University System of Maryland. All employees are expected to work
primarily physically within the State of Maryland. Regular and contractual employee are eligible for a
comprehensive benefits package

About the Team

The University of Maryland School of Medicine (SOM) was chartered
in 1807 as the first public medical school in the United States. It
continues today as one of the fastest growing, top-tier biomedical
research enterprises in the world. SOM is dedicated to providing
excellence in biomedical education, basic and clinical research,
quality patient care and service to improve the health of the
citizens of Maryland and beyond.