The University of Maryland, Baltimore (UMB), School of Medicine, Department of Cardiovascular Medicine is seeking a Senior Research Project Coordinator . The position independently manages operations of two or more research studies or clinical trial protocols. Serves as the primary liaison to other departments, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources. Provides guidance and direction to personnel engaged in research studies or clinical trials to ensure compliance with protocols and overall clinical objectives.
UMB offers a generous benefits package that includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
Develops and tracks work flow policies and progress through the duration of the research study or clinical trial. Assists Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing research studies or clinical trials.
Responsible for the development, implementation, modification, and evaluation of policies and procedures related to the deployment of protocols.
Provides training and guidance to less experienced personnel. Serves as primary contact and resource in absence of manager.
Oversees subject enrollment to ensure that informed consent is properly secured and documented. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with research personnel.
Monitors activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Continuously educates and trains personnel on compliance and protocol. Identifies protocol problems, informs investigators, and assists in problem resolution efforts.
Manages complex study or trial data. Develops methods for collection, database storage, tracking, analysis, and interpretation of data.
Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Responsible for developing and producing custom and routine reports.
Reviews proposed study protocols to evaluate factors such as sample collection process, data management plans, and potential subject risks. Conducts quality assurance audits on data and regulatory documentation.
Obtains tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.
Coordinates budget development, expenditure adherence, grant applications, and maintenance of inventory on equipment and supplies.
Attends research study or clinical trial related meetings, conferences and teleconferences, as well as participating in any additional planning and development related activities.
Performs other related duties as assigned.
Education: Bachelor's degree in nursing, chemistry, biology, public health, psychology or another scientific discipline appropriate to position required.
Experience: Two (2) years of research coordination experience with at least one (1) year in research specialization.
Phlebotomy experience is required.
Preferred Exp.: Certification from Association of Clinical Research
Professionals or Society of Clinical Research Associates are preferred.
Other: May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation.
May consider a combination of directly related experience and education.
Knowledge, Skills, and Abilities:
Possesses a knowledge of position requirements and able to perform position in compliance with all requirements/regulations/laws. Ability to understand and utilized scientific/medical terminology and research theory. Ability to gain knowledge and meet the reporting needs of UMB policies and practices for Institutional Review, Human Protections, Animal Protections, etc. Ability to maintain high standards with the work being performed and maintain awareness with trends and influences. Assumes personal responsibility for all outcomes; makes effective and timely decisions; and learns how to effectively use technology. Maintains productivity and uses knowledge strategies to increase knowledge base. Skill in continuously seeking to improve the quality of services and processes.
Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Writes and presents information in a clear and concise way. Interprets and understands written information and is able to listen attentively to verbal and non-verbal cues that lead to a deeper understanding.
Ability to work cooperatively with others and demonstrates professional, ethical, respectful, and courteous behavior when interacting with others. Capable of interacting pleasantly and positively with other to meet customer expectations, and provide follow up with customers.
Hiring Range: Commensurate with education and experience
If accommodations are needed for a disability, please contact Staffing & Career Services at 410-706-2606, Monday – Friday, 8:30am – 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans, and individuals with disabilities are encouraged to apply.
Job: Reg or CII Exempt Staff - E3314D
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Job Posting: Sep 13, 2018
Unposting Date: Sep 27, 2018, 3:59:00 AM
Internal Number: 101261
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.