Clinical Research Assistant or Senior Clinical Research Assistant

Job Description

The Institute of Human Virology (IHV) is currently recruiting for a Senior Clinical Research Assistant or Clinical Research Assistant. This position will provide research assistant support for study(ies) implemented by the Research Initiative for Infectious Disease and Substance Use (RIIS).

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. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 15 paid holidays, 3 personal leave, 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 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.

• 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 (HIPAA) 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 SPSSS 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 ensures protocol compliance while participants are in a study.
• Performs other duties as assigned.

• Communicates directly with participants regarding the research study. Perform data collection by conducting research interviews, reviewing medical charts, and accessing computerized medical information systems. Recruits and screens subjects for research studies according to IRB approved protocols. Depending on research specialty, may verify participant eligibility; obtains consent and enrollment; and assures accurate demographic information for follow-up.
• Independently establish and maintain 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.
• Perform data analysis and interpretation and develop statistical reports of study data using descriptive statistics using SAS, STATA, and SPSSS software. Assists in developing, submitting, and providing content for grants, papers, abstracts, manuscripts, and presentations. Conducts and analyzes literature searches.
• Assist the Principal Investigator and other research personnel in the development of research protocols and materials by providing study analysis and forming conclusions and recommendations.
• Perform administrative duties such as: providing training and guidance to interviewers; 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…