Develops, coordinate and implement a comprehensive training program for all research staff including physicians affiliated practices conducting research at Christiana Care. Develops and implements a comprehensive continuing education program at Christiana Care for all researchers including physicians, nurses and ancillary staff members. Develops and maintains all policies and procedure related to research, research finance, and research related activities. Develops and maintains the SOP's for research for the Institution Manages and coordinates all aspects of the Conflict of Interest in Research campaign. Acts as the system Administrator for the ClinicalTrials.gov reporting system. Is a liaison for the research community for all education, policy and procedure and compliance issues. Collaborates with all disciplines to ensure compliance to a variety of regulations related to research. Develop CNE based education and training events for nurses in the research community. Develops and manages an inspection system to track regulatory compliance, SOP compliance and safety issues. Develops corrective and preventive action plans if necessary to prepare for audits (FDA, Sponsor, OHRP, NIH, Office of Civil Rights, Federal Trade Commission or any other regulatory agency that oversees conduct of research).
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Provides leadership and guidance to Christiana Care's research community and affiliated physician practices Develops, implements and manages training and programs for Christiana Care's research community and for outside physicians who want to do research at Christiana Care Coordinates the education, training, and content of the Conflict of Interest in Research campaign according to all relevant federal and nonfederal regulations Reviews and manages all research financial disclosure statements according to CCHS and federal policies and procedures. Monitors the education needs and gaps in the research community and provide the resources need to fill that gap Develops and implements web based mandatory training through the Christiana Care Education Center that focuses on Good Clinical Practice Guidelines, research Conflict of Interest, Effort Reporting, Policy and procedure compliance and all research related topics.. Develops, composes, and revises Standard Operating Procedures ( SOPs) to enhance departmental infrastructure and reinforce consistent research practices Develops and manages Quality Assurance Departmental Audits to ensure quality and regulatory complianc e Collaborates with Research Finance to ensure compliance and consistency with all OSP processes and procedures Partners with Christiana Care Academic Affairs to standardize residency research training programs to include protocol development, scientific integrity, Institutional Review Board (IRB) training and continuing human subject protection Collaborates with Christiana Care Fellowship Program directors to establish a standard educational plan for new fellows Collaborates with the Chief Compliance Officer to ensure appropriate compliance of research activities at CCHS Coordinates regularly scheduled Research Education events and disseminates information to the research leaders at these events Collaborates with Nursing Research to assist in the educational needs of staff nurses performing research Attends multi-disciplinary team meetings related to research, research education and compliance issues. Sustains continuous internal regulatory compliance oversight for effort reporting and conflict of interest for Christiana Care Research and continuously audits related systems and controls to ensure risk mitigation And Research Enterprise-wide) regarding ER and COI Provides technical assistance to all users and facilitates any modifications to the ER and COI systems necessary to maximize functionality of tracking systems Performs assigned work safely, adhering to established departmental safety rules and practice s ; reports to supervisor, in a timely manner, any unsafe activities, conditions, hazards, or safety violations that may cause injury to oneself, other employees, patients and visitor s . Performs other related duties as required
EDUCATION AND EXPERIENCE REQUIREMENTS:
Bachelor's degree in Business, Healthcare or related field.
Master's degree preferred
5+ years Research Management Experience
2+ years of Grant/Finance Experience
Direct Participation in Food and Drug Administration Audit preferred
Human Subject Protection Training is required
Certification in Clinical Research required
Good Clinical Practice Training required
An equivalent combination of education and experience may be substituted
KNOWLEDGE, SKILL, AND ABILITY REQUIREMENTS:
Knowledge of current clinical concepts and practices of all departments involved in research at Christiana
Knowledge of the Research Process
Knowledge of the appropriate chain of command
Knowledge of Christiana Care Health system, departmental and Unit specific standards, procedures, protocols and policies
Knowledge of Christiana Care Research Standard Operating Procedures
Knowledge of regulatory principals governing the conduct of research Knowledge of FDA guidelines
Knowledge of NIH guidelines
Knowledge of Safety Reporting and Pharmacovigilance.
Knowledge of preparation, maintenance and closure of IRB documents
Knowledge of grant submission process and spend down
Ability to perform as an effective leader
Ability to collaborate with physicians, principal investigators, nurses and research staff. Ability to maintain open lines of communication
Ability to exercise judgment, tact, and diplomacy
Ability to act independently within the research department
Internal Number: 47271BR
About Christiana Care Health System
Christiana Care Health System is headquartered in Wilmington, Delaware and is one of the country's largest health care providers, ranking 21st in the nation for hospital admissions. Christiana Care is proudly a Nurse Magnet recognized institution. Christiana Care Health System is also one of the largest health care providers in the mid-Atlantic region, serving all of Delaware and portions of seven counties bordering the state in Pennsylvania, Maryland and New Jersey. A not-for-profit, non-sectarian health system, Christiana Care includes two hospitals with more than 1,100 patient beds, and is a major teaching hospital with two campuses. Christiana Care is continually recognized for excellence on a regional and national level. Our role in the community is expressed in the Christiana Care Way: "We serve our neighbors as respectful, expert, caring partners in their health. We do this by creating innovative, effective, affordable systems of care that our neighbors value."Christiana Care is a great place to work because we value diversity and recognize it to be a core part of our success. Because of the diversity of our employees, affiliated health professionals and volunteers, we are... positioned to meet the unique needs of our patients and community. We acknowledge and celebrate the uniqueness and talent of each employee. Because of our talented workforce we are able to provide a quality healthcare experience to our patients and community. We strive to create an inclusive environment in which individual diversity can be leveraged and thrive. Christiana Care Health System is an equal opportunity employer, firmly committed to prohibiting discrimination, whose staff is reflective of its community and considers qualified applicants for open positions without regard to race, color, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.