Clinical Research Program Administrator

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.

Administration:

• 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.

Compliance/Quality Assurance:

• 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.

Supervision:

• Hires, supervises and evaluates Clinical Research Associates, Clinical Research Coordinators, Research nurses and support staff.

Information Systems:

• 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.

Decision Support:

• 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.

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.

Preferred Qualifications:

• 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.