Description
Responsibilities:* Co-monitor with CRO monitors as needed and otherwise represent the study sponsor at visits to clinical study sites
* Evaluate the performance of clinical study centers, CRO monitors and other vendor service providers and work with the team to ensure that performance aligns with expectations and timelines
* Review study data listings for completeness, accuracy and appropriateness at the direction of the Medical Monitor
* Work with the sponsor team to coordinate activities of multiple vendors supporting a large multi-national program
* Assist the medical monitor and Investigator in setting up Investigator sponsored studies
* Develop training materials for CRO and study sites. * Represent the sponsor at meetings with vendors, study centers and the medical community.
The position requires extensive experience as a CRA and therapeutic experience in oncology, with some experience with hematologic malignancies preferred. The candidate should have knowledge of ICH-GCP and a strong interest in clinical research.
o Excellent verbal, written, interpersonal and presentation skills.
o Working knowledge and experience with Word, PowerPoint and Excel.
o Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
o Ability to recognize problems and react quickly and effectively to resolve them
o Abilty to quickly understand and execute new complex tasks
Qualifications:
* BS degree in science, nursing, or equivalent.
* At least five years of experience in clinical research, with at least three years as a CRA.
* Previous monitoring experience is required
* Willingness to travel 40 - 60%.
* Previous experience strongly preferred in the following areas:
o Working with Investigator Sponsored Studies
o Developing clinical operations SOPs
o International Phase 3 pivotal studies
o Supporting an NDA (EMEA)
To find out more about Real please visit www.realstaffing.com