Clinical Research Associate, Clinical Operations
Location: Ellicott City Maryland
Description: Questcor is looking of Clinical Research Associate, Clinical Operations right now, this position will be placed in Maryland. Further informations about this position opportunity please give attention to these descriptions. Overview:
Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2! 011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options.
The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately B.
We are currently seeking an Clinical Research Associate, Clinical Operations .
The individual will be part of the Research and Development Group (R&D) which is responsible for all FDA related research a! nd supports all non-FDA company sponsored research. The indivi! dual will work with the Clinical Project Managers to manage, execute and report on clinical trials. Questcor has studies or is planning studies in Phase 1-4. The individual will also be part of a multidisciplinary project team throughout the
conduct of the assigned clinical trials under the guidance of the Associate Director of Clinical Operations.
Responsibilities:
Monitor clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations, and ICH/GCP Guidelines Coordinate necessary activities required to set-up, monitor, and close-out clinical trial sites Conduct site assessment, initiation, routine, and close-out monitoring visits Complete accurate monitoring visit reports and follow-up letters Train study site personnel in the clinical protocol, study procedures, and electronic data capture as required Participate in the development and review of study-related documents including informed consent forms and case ! report forms Ensure proper storage, dispensation, and accountability of investigational products is maintained Work with sites to ensure appropriate and timely submission of IRB documents for site approval and to collect and maintain study documents for files Filing study-related documentation into Trial Master Files for multicenter studies and fulfill other in-house roles. Assist with enrollment tracking and recruitment strategies Assure adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures and all applicable SOPs Review the quality and integrity of the clinical data through (1) on-site source verification and (2) in house review of electronic CRF data Collect completed Case Record Forms (CRFs) from clinical trial sites Ensure timely and accurate data query resolution Transmit information from investigators to internal study team as necessary Assist with and attend Investigator Meetings Skills and Specifications: Open and cle! ar communicator Confident and influential approach Make independent cho! ices and take responsibility for own actions Task prioritization and timeline adherence Recognize potential obstacles and work to resolve them within set timelines Excellent planning and organization skills Well versed in clinical research methods and biological sciences Effective use of English language, both written and oral Should be familiar with pharmaceutical clinical studies Multi-tasking ability with project management skills Conscientious and precise delivery of work even when under pressure Pays attention to detail Willingness to travel up to 40-50%
Job Dimensions:
To perform this job successfully, the individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Language Ability:
Ability to read clinical protocols and all associated materials. Ability to assist in the preparation of clinical documents, business correspondence, and p! rocedural manuals. Excellent communication skills, including the ability to effectively present information and respond to questions from project teams, external vendors and clinical sites. Prior experience and demonstrated success in working with Investigators and research coordinator teams required.
Operations Ability:
Ability to maintain systems and processes necessary to report trial status and activities. Ability to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
Computer Skills:
Microsoft Project, Microsoft Word, Microsoft Excel, Microsoft Outlook
Qualifications:
BA, BS or RN in nursing, science or business-related field Minimum of 0-2 years of on-site monitoring experience; or 5 years relative industry experience
Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k)! , ESPP and stock options.
For more information, you may view o! ur website at http://www.questcor.com/careers/company-benefits.
Questcor is an Equal Opportunity Employer.
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If you were eligible to this position, please email us your resume, with salary requirements and a resume to Questcor.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Wed, 04 Sep 2013 12:16:37 GMT