Clinical Research Lead Specialist
- Employer
- University of Maryland Baltimore
- Location
- Baltimore, MD
View more
- Administrative Jobs
- Academic Affairs, Research Staff & Technicians
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
Job Details
The University of Maryland, Baltimore (UMB), Department of Medicine - Division of Pulmonary & Critical Care is currently recruiting for a Lead Clinical Research Specialist.
Benefits Information:
UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, 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 employees are strongly encouraged to follow all CDC recommendations related to COVID-19 vaccinations and booster doses. Employees whose job duties require them to work in clinical settings or at clinical or field sites continue to be subject to the vaccine requirements of those sites. For additional information on protocols and exemptions, please visit the COVID-19 website.
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 ensure 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 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 the management of day to day clinical research operations and leads 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.
- 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 experience members of the research team.
- Trains and provides mentoring to other research personnel in implementation of research protocols, IRB submissions, research procedures and policies, etc. Serves as subject matter expert and provides guidance for staff, faculty, and leadership. Develops 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 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.
Supervisory Experience: N/A
Certification/Licensure: N/A
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 Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery. Hiring Range: Mid 70's up to 80K (Commensurate with education and experience)
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 HRJobs@umaryland.edu.
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.
Job: Reg or CII Exempt Staff
Shift: Day Job
Organization: School of Medicine - Department of Medicine
Job Posting: Aug 8, 2022
Unposting Date: Aug 22, 2022, 10:59:00 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
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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