Research Project Specialist (Clinical Research Specialist)

Job Description

The University of Maryland School of Medicine’s Institute for
Clinical and Translational Research (ICTR) is currently recruiting
a Research Project Specialist. The Research Project Specialist is
responsible for coordinating the department's day-to-day operations
of research studies.

PROJECT OVERVIEW

My Healthy Maryland Precision Medicine Research is a long-term
study developed by the University of Maryland School of Medicine’s
Institute for Clinical and Translational Research. This project
aims to create a resource representative of the diversity of
Maryland to advance a broad range of health-related research, from
understanding the genetic and molecular basis of rare and common
health conditions to improving the value and efficiency of our
healthcare system.

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

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: Bachelor's degree in a scientific field of
study related to the research of the clinical setting. Three (3)
years clinical research including two (2) years in the relevant
research specialization.; 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 may
be substituted for the education or experience requirement.
Knowledge, Skills, Abilities: Accomplishes responsibilities by
applying specialized and theoretical knowledge, principles, and
concepts of a professional discipline normally acquired through
advanced education or specialized training. Resolves issues and
significant matters on behalf of management by utilizing
independent judgment, discretion, creativity, and analytical
thinking. Contributes to development and evaluation of goals and
objectives. Creates solutions to ensure legal and policy
compliance. May supervise, mentor, or coordinate work of others
(positions that supervise are responsible for service delivery,
quality assurance, and employee performance). May independently
manage or administer programs, processes, projects, or resources.
Applies in-depth, senior level knowledge, concepts, principles, and
skills. Wide latitude in decision making to interpret unclear or
inadequate guidelines. Supervisor and employee collaborate to
develop goals and objectives. Confers with supervisor only on
controversial or far reaching matters. Proactively resolves broad
and unique matters requiring sophisticated analysis and
interpretation. Acts as resource to others. 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.

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