Responsible for overseeing research projects, and ensuring that
nurses and staff are aware of study protocols.
Oversees day to day clinical research operations that require
expertise of a Registered Nurse and leads study design, initiation,
execution, and completion of clinical trials, research studies, or
projects. Ensures compliance of assigned staff with study protocols
and overall clinical objectives.
Follows the clinical courses of patients enrolled in clinical
research studies by obtaining results of diagnostic studies,
assessing patients for complications, and recording patient data
onto study forms.
Assists principal investigators (PIs) in obtaining
consent.
Oversees patient/family education concerning clinical
studies.
Interacts with patients and families to solicit adverse event
(side effect) information as well as medications taken since last
visit.
Maintains lines of communication between the institution and
the study sponsor by preparing study reports and communicating with
clinical study monitors.
Monitors study activities to ensure compliance with protocols
and with all relevant local, federal, and state regulatory and
institutional policies.
Confirms appropriateness of drug doses in accordance with
protocols.
Performs Institutional Review Board (IRB) and Health Insurance
Portability and Accountability Act (HIPAA) protocol development and
ensure compliance of research operations with protocols.
Identifies protocol or patient problems, informs investigators
of problems, and resolves problems by making protocol modifications
or adjustments to care plans. Develops, recommends, modifies, and
implements policies and procedures and/or methods of clinical
research to meet changing needs and requirements and enforces
standards.
Prepares and responds to audits conducted by study
sponsors.
Performs day-to-day operational duties such as: Assists
regulatory coordinators in communicating with the IRB.
Assists pharmacokinetic specialist (PK) in obtaining clinical
samples from patients and preparing samples for processing.
Serves as the primary liaison to other departments, outside
organizations, government agencies, and sponsor to promote
effective and efficient operation and use of resource. Establishes,
maintains, and fosters a cooperative relationship between the
members of the research team and support staff by communicating
information; responding to requests; building rapport;
participation in team problem-solving methods. Oversees the
recruitment, performance, scheduling, and training of team members
and continually reviews strengths and weaknesses of staff to
maintain a well-trained, highly involved, and motivated team.
Instruct and train research and nursing staff in scientific and
procedural aspects of studies including standards of care, informed
consent procedures, and documentation procedures.
Performs other related duties as assigned.
Qualifications
Education: Bachelor's degree in Nursing or another
discipline appropriate to position.
Experience: Five (5) years as a Registered Nurse with at
least one (1) year in research specialization. Additional years of
research preferred. Prior experience in oncology nursing or
investigational/therapeutic clinical trials preferred. Experience
in patient or project management preferred.
Certification/Licensure: Current Maryland license in good
standing issued by the Maryland Board of Nursing to practice as a
registered nurse or a multi-state licensure privilege to practice
as a registered nurse in Maryland or appropriate federal district
licensure where research is conducted.
Other: Certification from Association of Clinical Research
Professionals or Society of Clinical Research Associates preferred.
May require training related to occupational safety and health,
environmental compliance, shipping of hazardous materials and/or
ionizing radiation.
Knowledge, Skills, and Abilities
Ability to communicate effectively orally and in writing. Ability
to gather and interpret quantitative and qualitative data. Ability
to operate computers and other office equipment. Skill and ability
to interact with the public, health care providers, agencies, and
facilities. Thorough knowledge of and compliance with
confidentiality of records and communications regarding clients.
Thorough knowledge of the Maryland Nurse Practice Act for
Registered Nurses preferred. Thorough knowledge of the principles
of aseptic technique and infection control including blood and body
fluid precautions preferred. Ability to perform extensive standing
and walking preferred. Thorough knowledge, skill, and ability to
perform various medical and nursing procedures and to operate
medical equipment preferred.
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.