Proclinical is currently recruiting for an OCRA with a global biotechnology company located in Austin, TX. As the OCRA, you will re-train CRO CRAs and/or sites as needed.
- Conduct oversight visits to assess CRO CRA and Investigational Site performance.
- Use experience and knowledge of ICH/GCP guidelines, protocols, Investigator's Brochure, etc to identify issues and recommend solutions.
- Escalate critical issues to the company Management team immediately, and communicate non-critical issues in a timely manner; ensure the company and CRO team are made aware of any trends that may affect multiple study sites and/or the study as a whole.
- Write oversight visit reports, providing feedback on identified issues, actions taken and/or proposed solutions.
- Follow-up on identified issues by conducting additional oversight visits as needed and/or working with the CRO CRA and Company/CRO management teams as needed to provide resolution.
- Provide co-monitoring assistance to CRO CRAs.
- Conduct pre-study visits, initiation visits, monitoring visits and/or close-out visits.
- Assist in study document creation/revision.
- Create training materials, conduct team trainings and/or present at Investigator Meetings.
- Create, maintain, and/or review spreadsheets and data listings.
- Conduct file audits.
Skills and Requirements:
- 5+ years of experience as a Clinical Research Associate.
- Therapeutic and/or clinical experience in chronic kidney disease and dialysis preferred.
- Therapeutic and/or clinical experience in patient reported outcome, liver disease, and/or dermatological condition would be an advantage.
- Ability to work across multiple trials and multiple therapeutic indication.
- Detail-oriented with strong communication skills (oral and written) and ability to prepare accurate monitoring visit report quickly.
- Ability to be flexible and a team player is a must.
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.