Research Specialist, Clinical - SOM Oncology Program

University of Maryland, Baltimore (UMB); Maryland; Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

The University of Maryland, Baltimore (UMB) Hematologic Malignancies program seeks a Clinical Research Specialist to manage screening, enrollment, data collection, and regulatory compliance. You will coordinate IRB/HIPAA procedures, support trial protocols, and interact with investigators, staff, and sponsors.

You will handle data entry and analysis using SAS/SPSS/R, develop data collection tools, and ensure high-quality study conduct and documentation in a fast-paced cancer research environment.

Qualifications

• Experience in clinical research and data collection.
• Familiarity with IRB/HIPAA processes and regulatory standards.
• Strong data management and basic statistical analysis skills.

Responsabilités

• Provide technical expertise to clinical research programs and develop protocols and data collection instruments.
• Coordinate IRB/HIPAA protocol development and ensure compliance with study protocols.
• Interact with participants for eligibility, consent, enrollment, and data collection.
• Maintain databases, perform data checks, audits, and cleaning for quality control.
• Conduct data analysis using SAS, SPSS, and R, and prepare reports for stakeholders.

Connaissances

Clinical research

IRB compliance

Data analysis

Data management

SAS/SPSS/R

Formation

Bachelor's degree in a scientific field

Outils

Excel/Access

Description du poste

Job Description

This full-time position works Monday through Friday and may require scheduling flexibility that includes working outside of normal working hours.

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.

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.

Job Description

The University of Maryland, Baltimore (UMB) Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has an exciting opportunity for a full-time Clinical Research Specialist for the Hematologic Malignancies research program.

Following an extensive training program, the Clinical Research Specialist will be assigned a portfolio of cutting-edge novel therapeutic trials and will be the primary interface, along with the faculty member, for cancer patients enrolled in the studies. The Clinical Research Specialist will be responsible for screening, consenting, and enrolling patients as well s consequently guiding them through procedures and visits required by the research protocol. The Research Specialist is also responsible for data collection, resolving standard of care issues and direct research support. The Clinical Research Specialist will interface directly with the Principal Investigators on the protocols within their assigned portfolio as well as the medical care team, ancillary hospital staff, Sponsor representatives, and data managers within UMGCCC.

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.

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

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

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

Other: Except for qualifications established by law, 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 class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted. Some schedule flexibility may be required.

Knowledge, Skills, And Abilities

• Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
• Ability to perform independent projects.
• Ability to network with and provide information to key groups and individuals, and work as part of a team.
• Knowledge of human subjects research, the regulations and policies surrounding it.
• Prior experience with patients and patient interaction.
• Ability to represent the Cancer Center and its faculty in a professional manner.
• Ability to keep patient information confidential and possess knowledge of HIPPA regulations.

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 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

About The Team

The University of Maryland School of Medicine (SOM) was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world. SOM is dedicated to providing excellence in biomedical education, basic and clinical research, quality patient care and service to improve the health of the citizens of Maryland and beyond.