Prevailing Wage SOC Title :Clinical Research Coordinators
Prevailing Wage Skill Level:Level IV
Prevailing Wage:158808
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-02-22
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:158808
Wage Offer To:168808
Wage Offer Unit of Pay:Year
Workstie Address Line 1:1 Astellas Way
Worksite Address Line 2:
Worksite City :Northbrook
Worksite State:ILLINOIS
Worksite Postal Code:60062
Job Title:Clinical Study Manager
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Pharmacy, Health/Physical Services, or related
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :36
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:5
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:36
Accept Alternate Job Title:AsiaPacific Regional Lead Study Manager, Country Study Manager, or related role
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:Minimum Requirements Masters degree or the foreign equivalent in Pharmacy, HealthPhysical Services, or related, and 36 months in the job offered or as an AsiaPacific Regional Lead Study Manager, Country Study Manager, or related role.br br Alternate Requirements Bachelors degree or the foreign equivalent in Pharmacy, HealthPhysical Services, or related, and 60 months in the job offered or as an AsiaPacific Regional Lead Study Manager, Country Study Manager, or related role.br br Special Skills Three 3 years of experience serving as a project manager for multicountry clinical trials in Oncology at a pharmaceutical company, and three 3 years of experience involving all of the following a Authoring clinical protocols and developing processes for clinical drug development, including study design, study planning, investigative site qualification, and study management and monitoring for budgeting and resource allocations for clinical development programs; b Ensuring compliance with International Conference on HarmonizationGood Clinical Practice ICHGCP guidelines by reviewing submissions of trial applications to ethics committeesindependent review boards and regulatory authorities, including the U.S. Federal Drug Administration FDA, European Medicines Agency EMA, and Pharmaceuticals and Medical Devices Agency PMDA, as well as by supporting inspection readiness through involvement with implementation of corrective and preventive action plans based on internal audit findings; c Developing oncology Patient Informed Consents, numerous supportive Study Plans including the Clinical Monitoring Plan, and Case Report Forms using Medidata RAVE to operationalize study Protocol and data collection; and d Working on global oncology clinical trial development and execution including coordinating involvement and communication between multiregional internal and external stakeholders. Experience may be concurrent.br br Travel Requirement Requires 25 domesticinternational travel.
Combination Occupation :N
Offered to Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-04-09
Job Oder End Date:2021-05-11
Sunday Edition Newspaper:Y
First Newspaper Name:Chicago Tribune
First Advertisement Start Date:2021-04-18
Second Newspaper Name:Chicago Tribune
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-04-25
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-04-14
Job Search Website to Date:2021-04-28
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-04-16
Local Ethnic Newspaper to Date:2021-04-16
Radio/TV Ad from Date:2021-04-19
Radio/TV Ad to Date:2021-04-20
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:SOUTH KOREA
Foreign Worker Birth Country:SOUTH KOREA
Class of Admission :L-1
Employee Info
Foreign Worker Education:Doctorate
Foreign Worker Education Other:
Foreign Worker Major:PHARMACY
Year of Compelted Education:2013
Foreign Worker Istitution of Eduation:NORTHEASTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1:360 HUNTINGTON AVE.
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:BOSTON
Foreign Worker Educatution Institution State:MA
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:2115
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N
Foreign Worker Alternate Education and Experience :N
Foreign Worker Alternate Occupation Experience:Y
Foreign Worker Experience with Employer:N
Foreign Worker Employer Pay for Education:N
Foreign Worker Currently Employed:Y
Employer Completed Application :N
Preparer Name:Poonam Gupta
Preparer Title:Senior Counsel
Preparer Email :poonam.gupta@bal.com
Employer Information Declaration Name:Walter Garcia
Employer Declaration Title:Associate Director, Human Resources
