Description

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.



This is an excellent opportunity for an seasoned clinical research professional to apply established skills with developmental products through managing new and existing clinical studies. The incumbent will initiate and coordinate study start-up activities that may include protocol and investigator brochure writing and review, investigator selection, investigator meetings, budget planning and review, contract preparation, vendor selection, site selection, and CRF design and review. Manage study activities that may include oversight of CRO, Central Lab, and other vendors, reporting on study status, and ensuring timely completion within budget. Train vendors and clinical sites to ensure adherence to the protocol and compliance with ICH/GCP Guidelines. Support collection and review of essential document handling to include trip report approval. Significant interface with Global Project Team members including Outsourcing, Clinical Supplies, Quality Assurance, Statistics, Data Management, Safety, Medical, Operations, Pharmacology, Regulatory, and Marketing. Assist in preparation of clinical study reports for regulatory submissions and scientific publications. Based on the experience level of candidates, this position may be filled by either a Grade 16 or a qualified Grade 14/12.

** This is an in-house position.

Requirements

Qualifications:
The qualified candidate will have a minimum of three years experience as a CRA prior to hire date that includes site management and preferably significant experience with monitoring clinical studies. Experience with vendor (CRO, Central Lab, etc.) management also preferred. The candidate must have strong knowledge and demonstrated practice of ICH/GCP Guidelines. The candidate should have good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure. Familiarity with oncology is beneficial. Experience with regulatory submissions is a plus.
Bachelors Degree (BA/BS), from an accredited college or university, preferably in a health or biological science field.

Abbott welcomes and encourages diversity in our workforce. EEO/AA


To apply for this position, please visit us at: http://appclix.postmasterlx.com/track.html?pid=402881bd1b0b958c011b0f18e5a40ba1&source=hirehealth&p=codes=HIH,JB

To learn more about Abbott and view other opportunities, please visit us at: http://www.abbott.com/global/url/content/en_US/10:10/general_content/General_Content_00004.htm