Posting Summary: The Department of Emergency Medicine at the University of Virginia is currently seeking a Clinical Research Manager for the Emergency Medicine Research Office. The incumbent is responsible for the development and coordination of clinical trials and management of the planning, developing, and directing an overall clinical research program within the department including general Clinical Research Coordinator duties and responsibilities from initial concept, recruitment, monitoring review, and closure of grants and research projects. The CRC duties may include the collection of biomarkers and the steps/procedures to collect, store, and maintain the biomarkers in accordance with protocols and state and federal guidelines. The incumbent works with the department leadership, investigator, human subjects, IRB, University and the company and/or government sponsor to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Duties will include collaboration on the budget and coordinating the searches for appropriate grants and research opportunities as well as the general accountability of the program. The coordination of subject recruitment and consent, coordination of the scheduling of study procedures and research visits, as well as the collection of study data will be both managed and conducted by the incumbent. In additionally, they will manage the clinical research coordinators, data analyst, and supporting medical scribes to ensure that the monitoring of the subjects and subject availability is tracked and missed opportunities for subject interactions are limited based upon training and active engagements by the incumbent and the subordinate clinical research coordinators. Furthermore, the review and verification of operational effectiveness through quality assurance and regulatory data maintenance for studies will be required for defined periods and studies requiring validation.
The successful candidate is required to have a Bachelor's degree while a highly qualified candidate will have a Master's degree in public health science, science field, health related areas or business field. Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification required. Related Master's degree with significant work experience may substitute, with certification required within one year of certificate eligibility.
This position is currently limited to a 2-year assignment and is restricted and contingent upon the continuation of funding. Continuation of the assignment past the 2-year schedule is based upon continuation of funding and satisfactory performance as evident through performance evaluations and determinations by the department leadership.
Required Minimum Level of Education: *Degree Required
Required Specific Degree/Training: Bachelor's degree is required.
Preferred Minimum Level of Education: *Degree Preferred
Preferred Specific Degree/Training: A Master's degree in public health science, science, health and/or business field is preferred.
Required Minimum Level of Experience: Considerable - 4 to 7 years
Required Specific Experience: A minimum of six years of progressively responsible clinical research experience including clinical trials budgeting, managing clinical trials protocols, and training staff.
Preferred Minimum Level of Experience: Considerable - 4 to 7 years
Preferred Specific Experience: -Experience managing large multi-center and/or multi-PI / Co-PI / Sub-PI clinical trials. -Participation on Institutional Review Board for Health Sciences Research. -Experience designing, implementing, and managing university or academic based health and/or clinical research
Required License or Certification: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification required. Related Master's degree with significant work experience may substitute, with certification required within one year of certificate eligibility.
Required Knowledge, Skills and Abilities: 1. Ability to design, manage, and implement programs to fulfill state and federal policies and regulations. 2. Ability to conduct activities and make decisions according to ethical standards. 3. Deep knowledge of clinical research, human subject research ethics, and IRB procedures. Advanced knowledge of medical terminology. 4. Demonstrate excellent oral and written communication in daily interactions. Proven ability to clearly articulate specific information in area of subject matter expertise. Ability to recruit and screen potential research participants. 5. Demonstrate experience building, leading, motivating, and assessing, small professional teams. 6. Advanced ability to navigate University databases and systems. Advanced ability to plan the technological components and budgetary aspects of specific program. 7. Advanced ability to keep detailed records and manage and analyze confidential data. 8. Exemplify the University's educational mission, strategic aims, and programs. 9. Ability and knowledge of the collection of human biomarkers and skills necessary to effectively collect, store, and maintain such markers.
Preferred Knowledge, Skills and Abilities: 1.Knowledge of management techniques and methods for effectively manage large or multi-unit/PI based trials. 2.Academic based knowledge on designing, implementing, and managing health and/or clinical based research. 3.Management and leadership for medium to large groups of diverse personnel, programs, and services operating more than 12 hours per day. Ability to clearly articulate and communicate across the school, departments, and divisions while collaborating as a team member and a leader as needed based on task and requirements.
Required Computer Applications: Microsoft Word and Excel
Founded by Thomas Jefferson, the University of Virginia opened in 1825 as the nation's first public university. A longstanding dedication to preeminence in both scholarship and teaching; top ranking in global satisfaction, collegiality and work/family issues on the COACHE survey of early career faculty; a commitment to excellence that is integrally connected with diversity and a broad array of benefits make the University of Virginia a prime choice for both faculty and staff. The University of Virginia is located in the small cosmopolitan city of Charlottesville near the Blue Ridge Mountains, 70 miles from Richmond and 110 miles from Washington, D.C. The University of Virginia remains the No. 2 best public university in the 2013 edition of the U.S. News and World Report rankings. In the 14 years since U.S. News began ranking public universities as a separate category, U.Va. has ranked either No. 1 or No. 2. U.Va. continues to rank in the Top 25 among the best of all national universities, public and private.