Clinical Research Associate

at  Meridian Bioscience Inc

About Meridian:
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
Job Summary:
The Clinical Research Associate is responsible for the identification, qualification, management and monitoring of clinical study sites and reference laboratories to support Meridian Bioscience clinical development programs. Provide input on the development of the protocols, create the monitoring plan and other study material. Coordinate and oversee the execution of clinical evaluations and trials. Participate in departmental projects within Blood Chemistry, Immunology and/or Molecular at different phases, varying in scale and complexity.
Key Duties:

Tasks/Duties/Responsibilities:

• Responsible for the identification and qualification of study sites (verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff)
• Create and update the study monitoring plan and training material.
• Proactive subject/specimen recruitment forecasting and tracking.
• Primary site liaison for the conduct of the study and data query/resolution process.
• Perform study site monitoring visits (on-site, remote and risk-based) (site qualification, initiation, interim monitoring and close-out).
• Consult with investigators at assigned sites to ensure the study and monitoring activities are meeting expectations.
• Monitor case report forms and electronic data according to the protocol, labeling, applicable regulations (domestic and international when applicable) and GCP.
• Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective actions are implemented.
• Present study information and perform site personnel training at investigator meetings and site initiation visits.
• Participate in projects and/or initiatives identified by the Clinical Operations function or broader organization.
• Participate in and adhere to the Quality Program as defined by the QSR and to the Environment, Health and Safety SOPs.
• Monitor completeness and quality of Regulatory Documentation, performing site documentation verification, data collection and products accountability in accordance with ICH GCP guideline
• Complete monitoring reports, follow-up letters and site activation letters, which include providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance

Other Duties:

• Physical and Mental:
• Ability to walk up and down several flights of stairs daily.
• Ability to stand, stoop, reach, push and pull daily.
• Must be able to concentrate, analyze and solve complex issues daily.
• Ability to work on a PC including repetitive use of a keyboard and mouse daily.
• Must be able to lift a maximum of 20 pounds of supplies or finished product daily.
• Other:
• Ability to work with hazardous chemicals and biological agents with proper protection equipment.
• Must be able to identify and differentiate color on diagnostic devices or components.
• Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories

Qualifications:

Minimum Education or Equivalent Experience Required/Preferred:

• Bachelor’s degree in Biological/Health Sciences required, M.S. degree preferred; and at least 2 years of clinical research experience required. Or Registered Nurse with a minimum of an Associate degree in Nursing plus 5 years of work experience, preferably in a laboratory setting.
• Knowledge in more than one of the following areas: Microbiology, Immunology, Molecular Biology, Biochemistry, Blood Chemistry, Hematology preferred.
• ACRP or SoCRA certification and/or experience working in a CLIA certified clinical laboratory is a plus

Competencies Required or preferred

• Highly motivated, agile, analytical, detail oriented, solutions driven and able to plan/organize/prioritize workloads to meet strict critical deadlines and project timelines.
• Understands medical terminology and is familiar with clinical laboratory specimen processing techniques and Dx devices.
• Proven ability to communicate (verbal and written) clearly and effectively internally and externally with strong customer service.
• Ability to interact with KOLs, principal investigators and laboratory employees with confidence, gain trust of customers and stakeholders.
• Ability to establish rapport and build lasting relationships.
• Strong site performance management.
• Ability to see the big picture and how responsibilities impact the project success.
• Ability to read, understand and follow all company SOPs and guidelines.
• Proficiency with Word, Excel and PowerPoint programs.
• Demonstrated knowledge of Clinical Data Management Systems, EDC and eTMF.
• Must be fluent in English; French is a plus.

Tasks/Duties/Responsibilities:

• Responsible for the identification and qualification of study sites (verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff)
• Create and update the study monitoring plan and training material.
• Proactive subject/specimen recruitment forecasting and tracking.
• Primary site liaison for the conduct of the study and data query/resolution process.
• Perform study site monitoring visits (on-site, remote and risk-based) (site qualification, initiation, interim monitoring and close-out).
• Consult with investigators at assigned sites to ensure the study and monitoring activities are meeting expectations.
• Monitor case report forms and electronic data according to the protocol, labeling, applicable regulations (domestic and international when applicable) and GCP.
• Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective actions are implemented.
• Present study information and perform site personnel training at investigator meetings and site initiation visits.
• Participate in projects and/or initiatives identified by the Clinical Operations function or broader organization.
• Participate in and adhere to the Quality Program as defined by the QSR and to the Environment, Health and Safety SOPs.
• Monitor completeness and quality of Regulatory Documentation, performing site documentation verification, data collection and products accountability in accordance with ICH GCP guideline
• Complete monitoring reports, follow-up letters and site activation letters, which include providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure complianc

Other Duties:

• Physical and Mental:
• Ability to walk up and down several flights of stairs daily.
• Ability to stand, stoop, reach, push and pull daily.
• Must be able to concentrate, analyze and solve complex issues daily.
• Ability to work on a PC including repetitive use of a keyboard and mouse daily.
• Must be able to lift a maximum of 20 pounds of supplies or finished product daily.
• Other:
• Ability to work with hazardous chemicals and biological agents with proper protection equipment.
• Must be able to identify and differentiate color on diagnostic devices or components.
• Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratorie