Study Medication Nurse

Study Medication Nurse

Title: Study Medication Nurse
Location: USA-Kansas-Overland Park
Other Locations:

Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.

The Phase I division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. We are seeking a Study Medication Nurse for our Phase I Unit in our Overland Park, Kansas facility.

The Study Medication Nurse will prepare study drugs to be used in clinical trials according to applicable guidelines, regulations and SOPs, under general supervision, and ensure study drug-related documentation is complete and accurate. Additional responsibilities include:
* Assure compliance and documentation related to the receipt, storage, and dispensing of both investigational clinical trial supplies and non-study drugs.
* Oversee the return of investigational clinical trial supplies to the sponsor or their destruction.
* During project initiation, liaise closely with sponsor, project manager, and other project team members regarding pharmaceutical matters. Work closely with subcontractors needed for supply and preparation of investigational clinical
* trial products.
* Ensure that investigational clinical trial supplies are on site and that necessary documentation and authorizations are in place before the trial begins.
* Ensure that regulatory requirements for import and export of investigational clinical trial supplies are fulfilled. Perform packing and labeling of clinical supplies as needed.
* Assist QA during sponsor audits and regulatory inspections. Respond to internal and external audit/inspection findings in relation to investigational products and drug preparation room/area.
* Contribute to the development, review and implementation of standard operating procedures and ensure the safe and effective delivery of technical services through the use of these standardized procedures.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
* Familiarity with pharmacy calculations
* Ability to focus on detail
* Good organizational skills
* Good oral and written communication skills
* Good problem-solving skills
* Effective skill in using MS Office applications, i.e. Outlook, Word, Excel
* Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Nursing degree - either LPN or RN with experience in performing pharmacy calculations
* Valid RN licensure required by the state of Kansas