Research Project Specialist (Clinical Research Specialist)

University of Maryland, Baltimore (UMB); Baltimore (MD); On-site; USD 65,000 - 90,000; Full time

Job summary

University of Maryland, Baltimore (UMB) seeks a Research Project Specialist to coordinate day-to-day operations of clinical research studies. The role focuses on protocol development, ethics approvals, participant recruitment, and data management in a busy translational research environment.

The ideal candidate will possess a Bachelor's degree in a relevant field and 3 years of clinical research experience, with at least 2 years in a specialized area.

Qualifications

• Bachelor's degree in a scientific field related to clinical research.
• Three (3) years clinical research experience including two (2) years in the relevant specialization.
• Ability to develop and implement research protocols and data collection tools.
• Strong communication and collaboration skills.

Responsibilities

• Coordinate day-to-day clinical research operations and study initiation.
• Prepare IRB and HIPAA protocol development and ensure compliance.
• Manage subject recruitment, consent, and data collection processes.
• Perform data checks, audits, and data cleaning with Excel/Access.
• Support budget monitoring, invoicing, and coordination with IRB/other departments.
• Provide training and guidance to junior researchers as needed.

Skills

Clinical research

IRB/ HIPAA compliance

Communication

Education

Bachelor's degree in a scientific field

Tools

SAS

SPSS

R

Job description

Job Description

The University of Maryland School of Medicine’s Institute for Clinical and Translational Research (ICTR) is currently recruiting a Research Project Specialist. The Research Project Specialist is responsible for coordinating the department's day-to-day operations of research studies.

Project Overview

My Healthy Maryland Precision Medicine Research is a long-term study developed by the University of Maryland School of Medicine’s Institute for Clinical and Translational Research. This project aims to create a resource representative of the diversity of Maryland to advance a broad range of health-related research, from understanding the genetic and molecular basis of rare and common health conditions to improving the value and efficiency of our healthcare system.

Responsibilities

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 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. ' 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

Minimum Qualifications: Bachelor's degree in a scientific field of study related to the research of the clinical setting. Three (3) years clinical research including two (2) years in the relevant research specialization.; Additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job may be substituted for the education or experience requirement. Knowledge, Skills, Abilities: 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 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 in-depth, senior level knowledge, concepts, principles, and skills. Wide latitude in decision making to interpret unclear or inadequate guidelines. Supervisor and employee collaborate to develop goals and objectives. Confers with supervisor only on controversial or far reaching matters. Proactively resolves broad and unique matters requiring sophisticated analysis and interpretation. Acts as resource to others. 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.

About Us

The University of Maryland, Baltimore (UMB) is Maryland’s public health, law, and human services university. Six professional schools and the interdisciplinary Graduate School confer the majority of health care, human services, and law professional degrees in Maryland each year.

Our goal is to support the University’s mission of education, research, clinical care, and public service by amplifying UMB’s voice as a thought and action leader, and to enhance goodwill in the communities and people with whom we engage. 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.

UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.

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 [e-mail]. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.

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. Regular and contractual employee are eligible for a comprehensive benefits package.