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University of Maryland, Baltimore (UMB) · 3 weeks ago

OPEN RANK Clinical Research Assistant or Senior Clinical Research Assistant

Baltimore, MD

Full-time

Hybrid

Entry, Mid, Senior Level

$48K/yr - $53K/yr

2+ years exp

The University of Maryland, Baltimore (UMB) is seeking a Clinical Research Assistant or Senior Clinical Research Assistant to support research initiatives in infectious diseases and substance use. The role involves coordinating clinical research activities, ensuring compliance with protocols, and assisting in data collection and analysis.

BiotechnologyHealth Care

Responsibilities

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 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 ensure 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 requests and questions from individuals, institutions, government agencies, and funding agencies; and participating in the design of research studies

Performs other related duties as assigned

Qualification

Clinical research experienceData analysisSASSTATASPSSIRB protocol developmentDatabase managementMulti-taskingNetworkingCommunication skillsTeam collaboration

Required

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

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

May consider a combination of directly related experience and education

Prior clinical research experience preferred

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