Clinical Research Specialist

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thoracic transplants. The clinical center receives more than 1,500
new patient referrals each year and follows more than 4,800
patients who have been transplanted over the last two decades, as
well as more than 1,400 patients on the organ transplant waiting
lists.

Our leaders hold national and international prominence in their
fields and have translated their discoveries into clinical
management guidelines. We are one of only two transplant centers
serving more than 5 million people in Maryland.

The position is responsible for assisting with coordinating the
day-to-day operations of one or more research studies or clinical
trial protocols. The position coordinates data collection and
maintenance, project evaluation, meeting scheduling, and research
subject interfacing. The Clinical Research Project Assistant
adheres to good clinical practices, study protocols, and applicable
regulations, conducts complex work, contributes to measurable team
objectives, and uses discretion to solve issues. The position will
work in the Division of Transplant Surgery at the University of
Maryland, Baltimore School of Medicine. The division of Transplant
Surgery is located within the School of Medicine at the University
of Maryland, Baltimore, and maintains a large research portfolio
involving the heart, lung, liver, kidney, and pancreas.

BENEFITS (Exempt Regular):

UMB offers a comprehensive benefits
package that prioritizes wellness, work/life balance, and
professional development, along with additional exciting
perks that employees can take advantage of. This position
participates in a retirement program (pension or optional
retirement plan/ORP) that must be selected and is effective on your
date of hire. Exempt regular staff receive a generous PAID leave
package that includes over 4 weeks of vacation accrued each year,
16 paid holidays, 3 personal leave days, unlimited accrual of sick
time, and comprehensive health insurance; professional learning and
development programs; tuition remission for employees and their
dependents at any University System of Maryland school; and
flexible work schedules and teleworking options (if applicable per
job).

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.

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 :

MINIMUM QUALIFICATIONS

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

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

Supervisory Experience: N/A

Certification/Licensure: N/A

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.

KNOWLEDGE, SKILLS, 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 Respect and Integrity, Well-being and Sustainability, Equity and
Justice, and Innovation and Discovery.

HIRING RANGE: $64,000 - $75,000 per year / Commensurate with
education and experience

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
[email protected]
. 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.