Job Description
Clinical Research Associate II
Job Locations
US-Remote
Company
Meridian Bioscience, Inc.
Department
Research and Development
# of Openings
2
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 CRA II independently manages multiple protocols and/or sites, taking on moderate complexity studies. They are accountable for site-level performance, protocol compliance, and risk identification, with added responsibilities in cross-site coordination.
Key Duties
Manage multiple protocols of moderate complexity at a time and/or multiple sites within a protocol.
Independently perform all types of site visits (qualification, initiation, monitoring, and close-out).
Identify and resolve site-specific risks, including data quality issues and protocol deviations.
Facilitate site training on study protocols.
Oversee site-level patient recruitment strategies and compliance monitoring.
Collaborate with other study team members (e.g., data managers, regulatory specialists) to address site-level issues.
Act as the primary liaison between the sponsor and assigned sites, ensuring strong communication.
Prepare and submit visit reports, follow-up letters, and other required documentation within established timelines.
Assist sites in preparing for audits and inspections.
Review essential trial documents (e.g., case report forms, informed consent forms) to ensure proper documentation and compliance. Resolve data queries in collaboration with the site and data management team.
Support onboarding of new and/or junior level CRAs
Physical and Mental:
Ability to walk up and down several flights of stairs daily.
Ability to stand, stoop, reach, push and pull daily. o 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 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 or laboratory environment.
Qualifications
Bachelor's degree in Biological/Health Sciences required; with 3-5 years of clinical research experience required. Or minimum of 2 years of clinical research experience and plus 7 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 required.
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.
Assist in up to two studies and, following a successful break-out review, become independent in managing site activities and conducting monitoring responsibilities
Support in the preparation of site regulatory documentation
Understands medical terminology and is familiar with clinical laboratory specimen processing techniques and Dx devices is highly desired.
Proven ability to communicate (verbal and written) clearly and effectively internally and externally with strong customer service.
Ability to interact with site personnel, principal investigators and laboratory employees with confidence, gain trust of site personnel and stakeholders.
Solid understanding of GCP, ICH guidelines, and study-specific protocols.
Strong problem-solving skills and ability to handle complex monitoring activities.
Excellent communication and interpersonal skills.
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.
*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*
We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
