Research - Laboratory/Non-Laboratory, Staff/Administrative
The Director of Clinical Trials Research for the Division of Cardiac Surgery is responsible for the general administrative direction of the Clinical Trials Research Programs of the Cardiac. This role serves as the lead for the clinical trails involved in pediatric cardiac, adult cardiac and thoracic surgery. Oversees a constantly changing large number of highly complicated, high-risk, clinical trials requiring high clinical quality/safety standards within a high intensity setting involving multiple disciplines with acutely sick patients. Much of this work involves multiple institutions as well as multiple sponsors of research such as industry, NIH, foundations, etc. This highly complex situation and set of responsibilities requires a special balance of perspective, maturity, and creativity plus a commitment to excellence.
Development and Planning:
Manages the development of the clinical trials research program for the cardiac surgery division including: devising and implementing management strategies, quality assurance methods and developing tools for financial analysis. Plan, coordinate and oversee the delivery of research patient care services. Manages, analyzes, develops, and implements modifications of structural, procedural, and personnel components contributing to the efficiency and effectiveness of the division. Works closely with the Faculty, Research Nursing, and administrative staff to ensure appropriate clinical research practices are followed. Develops standards and procedures within the cardiac surgery division to coordinate the clinical research effort across the research programs.
Monitors research funds for activity and appropriates funds to support data management activities. Determines administrative and data management staff needs as protocols are open and conducted. Provides input on the feasibility of conducting trials, any conflict with ongoing trials, and logistical and administrative issues. Provides administrative coordination of affiliates; acts as liaison with national cooperative groups, and maintains information on investigational drugs, devices, therapies and diagnostics used by investigators. Manage the internal routing of clinical trials, site selection and study start-up while managing the clinical research contracts, payments and budgets.
Monitors all protocols to assure compliance with research as described in the protocol and compliance with IRB, State and Federal policies, procedures and regulations, acts as liaison between IRB and investigator. Maintain documentation, client files, and statistics as required by agency policies and funding sources. Develops quality control guidelines to conform to national cooperative group standards and assures successful audits of research data. Develops and oversees the audit program to ensure JHM policies and procedures are adhered to across JHM and all its entities.
Clinical Research Training:
Develops standard operating procedures and the training program for all research nursing and clinical research staff across all departments conducting cardiac clinical trial related research at Johns Hopkins and all its entities.
Hires, supervises and evaluates Clinical Research Associates, Clinical Research Coordinators, Research nurses and support staff.
As the end user, directs the development and maintenance of a protocol information management and analysis system, prepares data, and annual reports. Develops policies and procedures for the collection of centralized research data to ensure reporting of high quality data, sponsors, and Principal Investigator.
Responsible for provision of data, accurate data collection and analyses when requested by cardiac surgery, Department of Surgery and JHM leadership regarding strategic goals for clinical trial accrual including goals for minority accrual to clinical trials.
Supervision of Others:
Directs the management of team including, Research Nurses, Clinical Research Coordinators, Administrative and Clerical staff.
Master’s Degree in health-related sciences or related field required.
Five (5) years of experience in related clinical research required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: Advanced education (PhD) may substitute for required experience.For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
PhD in related discipline preferred.
Extensive experience in clinical discipline with clinical research sciences, regulatory affairs preferred.
Special Knowledge, Skills, and Abilities:
General computer skills, with experience with Microsoft Office
Must possess a proficient, working knowledge of the treatment of cardiac surgery related diagnoses; regulations governing clinical research from an institutional, state and federal perspective.
Managerial skills that include: Ability to work independently with minimal supervision, coordinate multiple tasks and establish priorities and deadlines.
Classified title: Clinical Research Programs Administrator
Working title: Clinical Research Programs Administrator
Role/Level/Range: ACRP 40/E/04/MF
Starting Salary Range: $70,805.04 - $97,437.60 (commensurate with experience)
Employee group: Fulltime
Employee Status: Exempt
Schedule: Monday-Friday –8:30am-5:00pm 40hrs/Wk
Location: SOM Campus – Baltimore, MD
Department name: 10003185-SOM Sur Cardiac Surgery
Personnel area (School): SOM – School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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