OPEN RANK Contractual Senior Clinical Research Assistant or Contractual Clinical Research Specialist

The Pulmonary, Critical Care, and Sleep Medicine Division has an exciting opportunity for a Contractual Clinical Research Specialist or a Senior Clinical Research Assistant to join our fun and productive team. This will be an excellent opportunity for an individual seeking stability and/or professional advancement.

Benefits: Contingent Category II

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. Contingent Category II staff receive a generous leave package that includes over 2 weeks of vacation each year, paid holidays, sick time, and time for community service; subsidized comprehensive health insurance and supplemental retirement options; professional learning and development programs; limited tuition remission for employees enrolled at UMB; life insurance and long-term disability; 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

Contractual Senior Clinical Research Assistant

• Responsible for facilitating and coordinating clinical research patient visits and data collection. The position will support the conduct of clinical trials, including the coordination of start-up activities, scheduling and preparing for patient visits, assisting with data collection and clarification, and general administrative duties.
• Assist in 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. May assist in developing and recommending policies and procedures and/or design methods for clinical research activities.
• Coordinates data collection of the research study including obtaining medical records, lab results, diagnostic results, visit notes, etc. Coordinates recruitment and screening subjects for research studies according to IRB approved protocols. May communicate directly with study participants.
• Coordinates paperwork for submission of IRB protocol, IRB amendments, and IRB continuing reviews. Document and report all adverse events as appropriate. Participates in audits and monitor visits as needed according to policy.
• Performs the coordination of data analysis and interpretation and develops statistical reports of study data using descriptive statistics using SAS, STATA, and SPSS statistical software. Assists in developing, submitting, and providing content for grants, papers, abstracts, manuscripts, and presentations. Conducts and analyzes literature searches. Develops and establishes a database to track research data.
• Coordinates development of research protocols and materials by providing study analysis and forming conclusions and recommendations.
• Documents in accordance with state and federal standards pertaining to specific research participant enrolled in the study. 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.
• Performs other duties as assigned.

OR

PRIMARY DUTIES

Contractual Clinical Research Specialist

• 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 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 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 :

Contractual Senior Clinical Research Assistant

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

Experience: Two (2) years of experience in clinical research in research being performed in unit.

Other: May consider a combination of directly related experience and education

OR

Contractual Clinical Research Specialist

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

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

Other: May consider a combination of directly related experience and education

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 Ranges: Commensurate with education and experience

Contractual Senior Clinical Research Assistant: $57,500 - $60,000

Contractual Clinical Research Specialist: $64,000 - $75,000