Nabi Biopharmaceuticals discovers, develops, manufactures and markets products that power the
immune system to help people with serious, unmet medical needs. The company has a broad
product portfolio and significant research capabilities focused on developing and
commercializing novel vaccines and antibody-based therapies that prevent and treat infectious,
autoimmune and addictive diseases, such as Staphylococcus aureus and hepatitis infections, ITP
and nicotine addition.
Due to our successful pipeline of drug candidates, Nabi Biopharmaceuticals is looking increase
the size of our clinical research organization with this newly created position:
Senior Clinical Research Associate
Conduct study initiation, monitoring, and closeout visits ensuring compliance with federal
regulations and Nabi policies and procedures. Work with staff at study sites to resolve data
discrepancies and provide timely and adequate distribution and return of drug supplies and
other study-related supplies. Write trip reports and investigator/site correspondence and
develop training manuals and other study-related documents. Maintain study files for
investigational and in-house sites. Frequent after-hour work and overnight travel required.
* Contribute to protocol drafting and informed consent and case report forms development and
approval. Review clinical research literature as needed.
* Independently evaluate and recommend selection of investigators/study sites; participate in
identification of potential sites.
* Independently train investigators, coordinator, and other trial staff in data collection
methods to ensure collection of patient data that is accurate, complete, and conforms to
project data standards and protocol requirements.
* Ensure the collection and updating of all essential documents defined by FDA regulations,
NABI SOPs, and general industry standards.
* Monitor and close-out clinical studies, ensuring adherence to protocol, accurate data
collection on CRFs via comprehensive source document verification, and drug/biologic
* Develop solutions for logistical and operational issues that arise during trials execution,
and communicate these in a timely fashion to investigators, coordinator and Nabi staff.
* Lead in the development and execution of Clinical Investigator Agreements/Contracts for all
sites in a trial, ensuring appropriate legal and clinical input.
* Understand and apply clinical scientific research and knowledge of the drug development
process, including significance of and differences between Phase I-III clinical trial design,
in all CRA activities.
R.N. or Bachelor's degree in biological sciences or other healthcare-related field. At least
seven years of pharmaceutical, clinical or bioresearch experience, including a minimum of four
full years as a Clinical Research Associate. Candidate must be able to work independently and
with teams; have excellent written and verbal communication skills; have strong computer
literacy; be detail-oriented and organized; be able to multi-task; have excellent
interpersonal and customer relations skills; be a self starter; and be flexible.
**Candidates with experience in Phase III or Phase IV trials, managing multi-site trials, and
overseeing junior-level CRA are highly preferred.
** Candidates with a background in renal clinical trials are highly desirable.
Please email or fax your resume and salary requirements to firstname.lastname@example.org or fax to
301-770-3097. ** PLEASE INDICATE JOB TITLE IN THE SUBJECT LINE OF YOUR EMAIL OR ON FAX COVER
**NO RESUMES OR CALLS WILL BE ACCEPTED FROM AGENCIES**
Nabi Biopharmaceuticals is an equal opportunity employer.
Please consider visiting our web site at www.nabi.com