Location:
Seattle , WA
Posted Date:
4/9/2012
Position Type:
FULL
Job Code:
WACRA1213
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Description
About AKP America
Asahi Kasei Pharma America (AKP America), formerly Artisan Pharma, is a biopharmaceutical company dedicated to bringing best-in-class critical care therapeutics to patients throughout the world. The company is a wholly-owned subsidiary of Asahi Kasei Pharma, Corp.
ART 123 (recombinant human thrombomodulin alpha, marketed as Recomodulin® in Japan), our lead product candidate, represents a promising new treatment for severe sepsis with coagulopathy. This drug has successfully completed a Phase 2b clinical trial in disseminated intravascular coagulation (DIC) and Phase 3 trials will be underway shortly. This product might also be beneficial for a number of other indications.
ART 123 (recombinant human thrombomodulin alpha, marketed as Recomodulin® in Japan), our lead product candidate, represents a promising new treatment for severe sepsis with coagulopathy. This drug has successfully completed a Phase 2b clinical trial in disseminated intravascular coagulation (DIC) and Phase 3 trials will be underway shortly. This product might also be beneficial for a number of other indications.
POSITION DESCRIPTION:
The Regional CRA is responsible for the site identification, selection, management, and monitoring activities at assigned sites in North America. The Regional CRA takes direction from the Clinical Trial Lead (CTL) and/or Clinical Project Manager (CPM) on projects as assigned.
Responsibilities
Key responsibility includes management and monitoring assigned sites in accordance with the Clinical Monitoring Plan, applicable SOPs and ICH/GCP:
Perform Pre Study Site Visits (PSSV), Site Initiation Visits, Interim Monitoring Visits, and Close out visits
Ensure that qualified investigators are selected with the appropriate site resources and patient population when conducting PSSVs
Perform 100% SDV of data, verify documentation and timely reporting of ICF, AEs and SAEs, laboratory sample collection and distribution, eCRFs including resolution of queries, ensure proper storage, dispensation and accountability of the investigational product
Ensure the collection, filing and maintenance of the required regulatory documents
Proactively prevent/identify issues related to the site i.e. study processes, site issues, screening/enrollment barriers while adhering to project timelines
Function as the primary site contact by maintaining regular contact and providing support to assigned sites including training/re-training of site personnel as needed
Other responsibilities:
Provide site updates/communicate study issues/escalate serious or outstanding issues to Clinical Trial Lead
Attend team meetings, teleconferences
Submit expense reports in a timely fashion
Document monitoring activities in reports, confirmation and follow-up letters, and on telephone contact reports
Report accurately and completely
Prepare and submit reports in a timely, concise and objective manner per the Clinical Monitoring Plan
Work with CTL and/or CPM:
Assist with study start up, study maintenance and study close-out activities
Attend and present at Investigator Meeting(s) and/or Study Coordinator Meetings
Projects as assigned
Other duties as assigned
Requirements
At least 5 years of CRA experience with all aspects of clinical monitoring (start up to close out and site management) of acute care clinical trials required. ICU/CCU/SICU experience as well as Phase 3 clinical trial experience with intravenous products is preferred.
Bachelors degree preferably in a clinical, science or health-related field (nursing, pharmacy and medical technology preferred) or relevant clinical experience
In-depth understanding and proficiency in ICH / GCP, FDA and local regulations is an absolute requirement
Excellent written and verbal communication skills, interpersonal skills and organizational skills
Proficient computer skills to include but not limited to:
Microsoft Word, PowerPoint, and Excel
Electronic Medical Records
EDC
Email/Web
Must have experience with maintaining a professional home office: Laptop/Printer/Scanner/Fax/Photo Copier, Cell phone/ Internet access, clinical trial files to support remote monitoring activities, etc.
Must have a valid driver’s license and be willing to travel up to 70% within North America
Asahi Kasei Pharma America (AKP America) is actively hiring new employees in the Boston area to support its product development efforts for ART-123. AKP America offers a competitive salary and benefits, a stimulating environment that values teamwork, and the opportunity and expectation for individual excellence.
To apply for one of these positions, please visit http://ak-america.iapplicants.com to access our online application process.
Asahi Kasei Pharma America Corporation is an Equal Opportunity Employer. Pre-employment background check and drug testing required.
Agency Notice
Asahi Kasei Pharma America (AKP America) does not accept unsolicited resumes from any third-party recruiters, agencies or individuals. Any such third party recruiters, agencies or individuals seeking to work with AKP America must first contact the staffing group at careers@akpamerica.com. Only approved staffing vendors will be allowed to provide services to AKP America. Unsolicited resumes will be deemed the property of AKP America to follow up with as it sees applicable and no fee will be paid in the event the candidate is hired as a result of the referral or by other means. Submission of unsolicited resumes does not create any implied obligation on the part of AKP America.
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