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NESCO Resource is currently recruiting for a Clinical Research Associate I for a 1-year contract position with our client in North Tucson, (Oro Valley), AZ.
POSITION SUMMARY: Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by company. 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).
Site Management & Monitoring:
- Conducts in-house monitoring, 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. 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.
- 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.
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%.
The candidate must have experience with site visits, study binders and case report forms from their previous experience with clinical study coordination or management, or clinical site monitoring.
- 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.
For immediate consideration apply now and/or contact me directly: Kristy Ramos at 520-505-4667.
If you would be interested in other positions in Tucson, we have several additional opportunities available please see www.nescoresource.com for more openings. If you know someone looking for a new opportunity we will pay you for your referrals!
NESCO Resource was named Best of Staffing for both client and staffing 6 years in a row! We offer medical, dental, vision, short term disability, life insurance and 401K!! We are excited to work for you!
At NESCO Resource, our flexible staffing solutions include contract, contract-to-hire, and direct placement services. We employ specialized recruiters focused in the fields of Engineering, Information Technology, Accounting & Finance, Administrative & Customer Service, and Manufacturing & Distribution.
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