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Lead Clinical Research Specialist

Employer
University of Maryland Baltimore
Location
Baltimore, MD
Closing date
Jun 21, 2021

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Academic Affairs, Research Staff & Technicians
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Job Details

Job Description
University of Maryland, Baltimore (UMB) is currently seeking a Lead Clinical Research Specialist to join the Department of Transplant Surgery. UMB was ranked one of America's Best Large Employers by Forbes Magazine (Feb 2021). SCOPE OF ROLE:
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 the 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 advanced, expert-level knowledge, concepts, principles, and skills. Substantial latitude in decision making. Sets goals and objectives to align with a defined strategy. Informs supervisor of progress. Works on ambiguous matters generally without precedent or structure and independently develops standardization and protocol. Makes departures from traditional approaches to develop novel solutions. Influences strategy, program, policy development, and best practices. Acts as an expert resource to others.
In the Fall of 2021, UMB will require all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.   PRIMARY DUTIES:
    Leads the highest technical research and guides research programs, projects, and activities in a clinical setting. Responsible for ensuring design, development, documentation, and implementation of research procedures and protocols using a variety of complex activities. Networks with faculty and staff to achieve strategic goals and maximize efficiency. Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards. Prepares for the Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensures compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities. Leads the management and analysis of clinical research data to include data analysis using statistical software, data collection, data entry, data verification, and ensure compliance and clinical relevance of data. Assists in the development and implementation of site tracking tools to comply with data monitoring requirements per federal regulations and guidance. Independently cleans, validates, and analyzes research data in order to prepare research findings for publications of journal articles and grant proposals. Leads the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trial Performs advanced 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 ensures 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 the management of day-to-day clinical research operations and leads study initiation, execution, and completion. Assist in the design and provide expert recommendations regarding research studies. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining a patient medical history. Provides 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, writes reports, prepares, and delivers presentations of relevant findings and conclusions, and recommends appropriate actions. Reviews analysis and reports of less experienced members of the research team. Trains and provides mentoring to other research personnel in the implementation of research. Performs other duties as assigned.


Qualifications
Education: Bachelor's degree in a scientific field of study related to the research of the clinic
Experience: Five (5) years clinical research including three (3) years in the relevant research specialization
Other: Master's degree in related field may be substituted for two (2) years of related experience KNOWLEDGE, SKILLS, ABILITIES:
Knowledge of position requirements. Knowledge of all applicable requirements, regEducation: Bachelor's degree in a scientific field of study related to the research of the clinic
Experience: Five (5) years clinical research including three (3) years in the relevant research specialization
Other: Master's degree in related field may be substituted for two (2) years of related experience 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 Accountability, Civility, Collaboration, Diversity, Excellence, Leadership, and Knowledge.  Hiring Range: Commensurate with education and experience (Mid $60K to Low $70K) UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy. For assistance related to employment, please contact the Staffing department at [email protected]. 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. ulations, 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 Accountability, Civility, Collaboration, Diversity, Excellence, Leadership, and Knowledge.

Job: Reg or CII Exempt Staff
Shift: Day Job
Organization: School of Medicine - Surgery
Job Posting: Jun 14, 2021
Unposting Date: Jun 18, 2021, 11:59:00 PM

Organization

Welcome to the Baltimore campus of the University of Maryland, founded in 1807 along a ridge in what was then called Baltimore Town. Today, this 61-acre research and technology complex encompasses 65 buildings in West Baltimore near the Inner Harbor.

The University is Maryland's only public academic health, human services, and law center. Seven professional and graduate schools train the majority of the state's physicians, nurses, dentists, lawyers, social workers, and pharmacists.

Under the leadership of President Jay A. Perman, MD, the University is a leading partner in the redevelopment of the west side of Baltimore. The University of Maryland BioPark, which opened in October 2005, promotes collaborative research opportunities and bioscience innovation.

Sponsored research totaled $567.1 million in Fiscal Year 2010. With 6,349 students and 6,717 faculty members and staff, the University is an economic engine that returns more than $15 in economic activity for every $1 of state general funds appropriation. The University community gives more than 2 million hours a year in service to the public.

Mission


The University of Maryland, Baltimore (UMB) is the State¹s public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.

 

Campus Data

University Facts at a Glance

 

Go to the Office of Institutional Research and Accountability for complete campus facts. 

 

Equal Opportunity


The University of Maryland is an Equal Opportunity/Affirmative Action employer and educational institution and does not discriminate on the basis of race, color, religion, age, ancestry, national origin, gender, sexual orientation, physical or mental disability, marital status or veteran's status to recruit, hire, compensate, train and promote employees and applicants for employment in all job levels with regard to their qualifications and without consideration to the aforementioned categories. Exceptions to this policy will be made only as allowed by law for example, due to bona fide occupational qualifications or lack of reasonable accommodations for disabilities.

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