Data Coordinator I

Responsibilities:

• Assists with the compliant data collection of multiple research projects.
• Assists PI and/or designee with the development, implementation and evaluation of research subject recruitment strategies.
• Assists with the development and coordination the research subject study schedule and calendar in compliance with the research protocol.
• Schedules and registers research appointments, procedures and tests and completes appropriate process for accurate billing to correct research account.
• Completes notification of schedule completion in applicable research protocol management system.
• Assists with the collection, recording and maintenance of accurate study records to include source documents, case report forms, regulatory documents and reports.
• Under direction of PI or designee, assists with the reporting of serious adverse events and unanticipated problems to the IRB, FDA and Sponsor in accordance with regulatory timelines.
• Assists with obtaining and organizing research data for assigned research studies, which may include medical record ordering and tracking, assisting with conducting research subject follow-up and interview in person or remotely, obtaining research subject information from medical records and assisting with specimen collection, processing and/or transport.
• Provides general support to research staff by performing research study related administrative activities, which may include clerical assistance, ordering, transporting and inventory maintenance and phone triage, scheduling of research administrative meetings.
• Assists with overseeing the appropriate procurement, storage and utilization of research equipment and supplies.
• Attends investigator meetings, study initiations and site visits as needed.
• Coordinates the implementation and maintenance of data bases for the Institute and central research administration management. Ensures all Institute data collection, monitoring, reporting, and analysis.
• Assists with the establishment of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with those of the sponsoring organization, external regulatory agencies and central research administration offices.
• Serves as a data reporting liaison with local, state and federal external agencies, communicating directly with agency personnel as necessary.
• Coordinates the implementation and maintenance of the research education program, tracking participation and certification.
• Coordinates development and design of data bases.
• Provides monitoring of research projects. Participates in the evaluation of research industry best practices for research to develop data collection for metrics that drive improvement.
• Serves as research team liaison, providing communication and consultation services as needed.
• Performs other duties as assigned by the Principal Investigator, the Chairman of the Department and by the Administrative leadership.

Education:

• High School graduate or equivalent.
• Knowledge of medical terminology.
• Bachelor's Degree may offset experience requirements.
• Strong organizational, communication and interpersonal skills.
• Must be self-directed with demonstrated ability to work independently.
• Ability to manage several complex projects in parallel and prioritize workload as required.
• Maintains current knowledge of applicable research data.
• Must have competent computer skills and knowledge of various software applications for the development of spreadsheets, databases and documents.
• Within 90 days of hire, must successfully complete training in Human Subject Research (HSR) as required by the Responsible Conduct of Research Guidelines as adopted by Cleveland Clinic.

Certifications:

• Continually demonstrates competency with defined requirements for the position as established by Cleveland Clinic.
• Society of Clinical Research Associates (SOCRA) or Association of Certified Research Professionals (ACRP) certification may be preferred.

Complexity of Work:

• All employees are expected to meet the standards of performance outlined in the Organizational-Wide Competencies listed below as applied to the position: World Class Service Orientation: Includes attitude, behavior, interpersonal skill, and problem solving that enable an employee to respond to internal and external customer needs and expectations in a positive manner.
• Adaptability: Includes teamwork and flexibility needed to fulfill job responsibilities including adapting to changes in work environment and accepting supervisory feedback.
• Efficiency and Effectiveness: Includes quantity and quality of desired work, as well as organization skills necessary to perform successfully.
• Essential Job Requirements: Includes adherence to all relevant policies, procedures, and guidelines affecting the work environment, including maintenance of required competencies and communication skills.
• Supervisory Responsibilities (if applicable): Includes overall accountability for assigned work group relative to operational goals, personnel requirements, and budgetary constraints.
• Note: The above stated duties are intended to outline those functions typically performed by individuals assigned to this classification. This description of duties is not intended to be all inclusive nor to limit the discretionary authority of supervisors to assign other tasks of similar nature or level of responsibility.

Work Experience:

• Minimum three years experience in a healthcare setting assisting with multiple projects/functions, with previous research experience preferred, and experience with a focus on research data maintenance.
• Additional years of related experience may offset the degree requirements.

Physical Requirements:

• Ability to perform work in a stationary position for extended periods
• Ability to operate a computer and other office equipment
• Ability to communicate and exchange accurate information
• In some locations, ability to move up to 15 pounds

Personal Protective Equipment:

• Follows Standard Precautions using personal protective equipment as required for procedures.