Specialist, Clinical Research Lead

The Division of Cardiovascular Medicine (CVM) for the
University of Maryland, Baltimore (UMB) has an exciting opportunity for a Lead Clinical Research Specialist
.

The Division of Cardiovascular Medicine (CVM) is dedicated topatient care, research, and education and wants to ensure our placeas a leader in cardiovascular treatment and research. Together withthe University of Maryland Comprehensive Heart Center, we are dedicated to improving the lives of individuals with heart diseaseusing the latest innovations in cardiovascular care. The selected candidate will perform duties that support the mission and visionof the department.

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, alongwith additional exciting perks that employees can take advantage of. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4weeks of vacation accrued each year, 15 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance;

professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).

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.

• Leads the highest technical research and guides research programs, projects, and activities in a clinical setting.
  
  Responsible for ensuring design, development, documentation and implementation of research procedures and protocols using a varietyof complex activities. Networks with faculty and staff to achievestrategic goals and maximize efficiency.
• 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 Portabilityand Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. Coordinatesdeveloping and recommending policies and procedures and/or design methods for clinical research activities.
• Leads the management and analysis of clinical research data toinclude data analysis using statistical software, data collection,data entry, data verification, and ensure compliance and clinicalrelevance of data. Assists in the development and implementation ofsite tracking tools to comply with data monitoring requirements perfederal regulations and guidance. Independently cleans, validates,and analyzes research data to prepare research findings forpublications of journal articles and grant proposals.
• Leads the development of project timelines, work plan,recruitment strategy, and progress through the duration of theresearch 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 surveyquestionnaires.
• Maintains communication with participants and colleaguesregarding 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 productrepresentatives to promote effective and efficient operation anduse 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, ensuringinformed 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 thebudget; budget negotiation and review, ensuring quality control andsafety compliance; serving as liaison with IRB, submittinginvoicing, 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. Reviewsanalysis and reports of less experience…