Responsibilities:

• Oversees the organization and compliant execution of research projects with the proper allocation of resources and adherence to research protocol requirements.
• Assures quality and safe patient care. Anticipates and resolves patient care and study issues by serving as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
• Oversees compliant research program operations and finances of assigned area(s).
• Participates in process improvement activities.
• Facilitates strategic planning and operational implementation.
• Collaborates with principal investigator, sponsor and research staff to plan, conduct and evaluate project protocols.
• Analyzes site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites, if applicable.
• Develops and maintains knowledge of research program and associated protocols to coordinate the comprehensive and compliant execution of protocols.
• Assists with preparation for and response to audits.
• Monitors and reports on progress of research projects based upon milestones and contractual payment obligations.
• Provides sponsor with individuals site forecasting schedules, if applicable.
• Works actively with the principal investigator and sponsor, if applicable, in tracking study progress, developing action plans for not meeting contractual deliverables/timelines, and developing a process to review and follow up with action plans that may include possible discontinuing study and/or site termination, if applicable.
• Supervises research personnel, ensuring orientation and training, performance management, and career development.
• Maintains professional relationships, including frequent and open effective communication with internal and external customers.
• Oversees the development of training materials and education of research personnel, fellows and staff in study execution and management.
• May assist PI with research study design and development of research protocol.
• Supervises and coordinates research project budget development.
• May negotiate industry sponsored research budgets.
• Supervises research subject recruitment and data management.
• Assists with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
• Identify, contract, and maintain orders with outside vendors supplying services for the study (examples could include shipping, laboratory services, laboratory supply vendors)
• May serve as primary contact for investigators, regardless of funding source, to facilitate research project development, processing and approval routing through the appropriate central research administration offices and systems.
• Performs other duties as assigned.

Education:

• Bachelor’s Degree in Business Administration, Science or a related field required.
• Advanced degree in health care, science or business preferred and may offset some of the experience requirements.
• Requires knowledge of budgeting, cost analysis, manpower planning, supervision and operational analysis.
• Ability to direct and evaluate the efforts of others.
• Demonstrates basic computer proficiency.
• Exceptional organizational, communication, interpersonal and analytical skills.
• Is self-directed with demonstrated ability to work effectively with a multidisciplinary team of professionals.
• Displays a thorough understanding of the research process and terminology, and in-depth knowledge of the specialty under investigation.
• Oversees adherence to federal regulations and good clinical practices (GCP).
• Within 90 days of hire, must successfully complete certification in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic.
• Continually demonstrates competency with defined requirements for the position as established by Cleveland Clinic.

Certifications:

• None required. Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification desirable.

Complexity of Work:

• Requires excellent interpersonal, organizational and management skills, critical thinking skills, decisive judgment and problem solving abilities.
• Must be able to work in a stressful environment and take appropriate action.

Work Experience:

• Minimum five years progressively responsible health care, research, or other relevant supervisory or managerial experience.
• Advanced degree in health care, science or business may offset some of the experience requirement.

Physical Requirements:

• A high degree of dexterity to produce materials on a computer.
• Requires normal or corrected vision and hearing to normal range.
• Extensive sitting and frequent walking, occasional lifting or carrying up to 25 pounds.
• May have some exposure to communicable diseases or body fluids.
• May require working irregular hours.

Personal Protective Equipment:

• Follows standard precautions using personal protective equipment as required.