Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by Company, Medical Affairs. Works closely with study manager 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). Works closely with project managers, Medical Managers, and Directors with project planning, implementation, and facilitating Medical Affairs various types of non-registrational projects.
Site Management & Monitoring:
- Conducts in-house, and may independently perform on-site monitoring in accordance with Company 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.
- Manage study supply inventory and shipping.
- Conduct and assess site readiness and assist in creating site monitoring plans
- Work across multiple project teams, indications, and differing study designs
- Assist in the creation of study materials (CRFS, operation manuals, protocols, etc.).
- Assist in the creation of departmental operating procedures and tracking systems.
- 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 paper and eTMF and electronic clinical trial management system
- 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.
Bachelor of Science, RN, or BSN; OR equivalent combination of education and 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.
- 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%.
Source: Job Diva – Job Listing