Clinical Research Associate

Clinical Research Associate

Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by Ventana Medical Systems. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).

The following study related tasks are fundamental to this position, but they may be expanded or omitted at the discretion of the Clinical Manager to more effectively complete clinical research activities:

Site Management & Monitoring:

• Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines and Regulations.
• Participates in assessing study risks.
• Communicates on behalf of the study manager with investigators and site staff.
• Prepares study performance reports and provides input into study budgets.

Study Implementation:

• Assists in preparation and independent execution of:
• Study training presentations for investigators and site staff.
• Study supply ordering and shipping.
• Investigational product release, labeling, accountability at study sites.
• Site Readiness and Site Monitoring Plans.
• Assay transfer and assay qualification activities.
• Study records including site and trial master files.
• Site qualification, site initiation, routine monitoring and close out visits and reports.
• Document compilation for clinical study reports and document archive activities.
• Data management activities including user acceptance testing, data entry, and data verification as needed.

Departmental Roles:

• Works within project teams to facilitate the conduct of standard study designs.
• Participates in clinical affairs meetings and completes independent activities to support departmental functions.
• Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking and training.
• Adopts clinical practices that promote Quality First Time.

Formal Training/Education:

Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.

Experience:

• 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience.
• Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred.
• A background in biomedical/healthcare services with laboratory experience preferred.

Knowledge, Skills and Abilities:

• Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
• Excellent writing and verbal communication skills.
• Well organized and detail oriented.
• Impeccable record keeping and filing skills.
• Excellent time management skills.
• Ability to give presentations and teach others.
• Ability to work effectively in a team, and also work independently on assigned tasks
• Ability to complete intermittent overnight travel up to 30%.