Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards. Prepares for the 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.

Leads the management and analysis of clinical research data to include data analysis using statistical software, data collection, data entry, data verification, and ensure compliance and clinical relevance of data. Assists in the development and implementation of site tracking tools to comply with data monitoring requirements per federal regulations and guidance. Independently cleans, validates, and analyzes research data to prepare research findings for publications of journal articles and grant proposals.

Leads the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trial.

Performs advanced 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.

Oversee the management of day-to-day clinical research operations and leads 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.

Provides 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, develop policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.

Searches relevant literature, develops conclusions, writes reports, prepares, and delivers presentations of relevant findings and conclusions, and recommends appropriate actions. Reviews analysis and reports of less experience members of the research team.

Trains and provides mentoring to other research personnel in implementation of research protocols, IRB submissions, research procedures, and policies, etc. Serves as subject matter expert and provides guidance for staff, faculty, and leadership. Develops 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 scientific field of study related to the research of the clinic.

Experience: Five (5) years clinical research including three (3) years in the relevant research specialization.

Supervisory Experience: N/A.

Certification/Licensure: N/A.

Other: Master's degree in related field may be substituted for two (2) years of related experience.

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 Range: $80,500.00- $93,000.00 (Commensurate with education and experience)

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 leave_and_accom@umaryland.edu 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.

Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards. Prepares for the 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.

Leads the management and analysis of clinical research data to include data analysis using statistical software, data collection, data entry, data verification, and ensure compliance and clinical relevance of data. Assists in the development and implementation of site tracking tools to comply with data monitoring requirements per federal regulations and guidance. Independently cleans, validates, and analyzes research data to prepare research findings for publications of journal articles and grant proposals.

Leads the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trial.

Performs advanced 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.

Oversee the management of day-to-day clinical research operations and leads 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.

Provides 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, develop policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.

Searches relevant literature, develops conclusions, writes reports, prepares, and delivers presentations of relevant findings and conclusions, and recommends appropriate actions. Reviews analysis and reports of less experience members of the research team.

Trains and provides mentoring to other research personnel in implementation of research protocols, IRB submissions, research procedures, and policies, etc. Serves as subject matter expert and provides guidance for staff, faculty, and leadership. Develops 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 scientific field of study related to the research of the clinic.

Experience: Five (5) years clinical research including three (3) years in the relevant research specialization.

Supervisory Experience: N/A.

Certification/Licensure: N/A.

Other: Master's degree in related field may be substituted for two (2) years of related experience.

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 Range: $80,500.00- $93,000.00 (Commensurate with education and experience)

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 leave_and_accom@umaryland.edu 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.