Clinical Research Specialist I
Company Name:
Artech Information Systems, LLC
Reference # : 14-31061 Title : Clinical Research Specialist I
Location : Minneapolis, MN
Experience Level : Start Date / End Date : 09/08/2014 / 04/30/2015
Description
Job
Summary:
Company: Artech Information Systems LLC
Job Title: Clinical Research Specialist
Job ID: 45003
Location: Minneapolis, MN
Duration: 8 Months
Job Duties :
Assists with successful conduct of assigned studies consistent with R&D and Marketing plans.
Assists in preparation of study materials and training of investigators, center staff and Healthcare field staff.
Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents.
Reviews clinical data/information and oversees data correction.
Assists study managers in providing interim and final reports and presentations.
Assists study manager in writing PMA Clinical Reports.,Reviews and approves center activation documents.
Work with the Clinical Study Manager to satisfy applicable regulatory standards.
EDUCATION/EXPERIENCE REQUIREMENTS:
BS degree, 1-3 years' experience with clinical site management, 1-3 years clinical & regulatory documentation experience and 1-3 years industry experience.
Manger would like experience with CTMS and RAD but it is not a requirement.
POSITION DESCRIPTION:
Works under the supervision of the study manager/project manager of a Humanitarian Device Exemption (HDE) to satisfy applicable clinical and regulatory requirements and internal requirements for managing the study/HDE. Major deliverables are reviewed to ensure clinical and business requirements are met.
POSITION
Responsibilities:
Under the direction of the study manager, the CRS will assist with review and writing of clinical plans, study/project work instructions and guidelines, as well as performing activities and generating reports for one or more significant subparts of the study (e.g. monitoring, data management, adverse events, deaths, protocol deviations, legal agreements, study training, patient informed consents, clinical document management).
Assists in the development of the Clinical Investigational Plan, Clinical Management Plan, Data Management Plan, study training materials, and study reports in consultation with the study manager, clinical team, and investigators.
Assists with site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
Responsible for limited site monitoring under the direction of more senior level CRAs (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, and company standards, guidelines and policies.
Prepare accurate and timely monitoring reports and follow action items through resolution.
Ensure accurate inventory accountability of investigative product at assigned clinical sites.
May participate in process improvement initiatives.
Assists in ensuring site activities in line with milestones (i.e. startup, recruitment, closeout, etc.) and implement contingency plans as needed.
Responsible for accurate and timely adverse event reporting during the study.
May ensure site adherence to FDA, Regulatory, IRB and Healthcare requirements.
Work with investigators to quickly and effectively resolve problems.
Required Skills:
Education Level: Undergraduate Degree
General Experience in a Clinical Study Research Environment: 1 - 3 Years
General Experience in a Health Care or Business Related Field: 1 - 3 Years
Knowledge of Medical Terminology: Good
Oral Communication: Good
PC Experience : Data Entry
PC
Experience: Internet Usage
Software Application Knowledge: MS Outlook
Windows 2000, MS Excel, MS PowerPoint
Travel: 0-10%25%20Travel
Written Communication: Good
Rajesh Kumar
Sr.Associate Staffing
240 Cedar Knolls Road, Suite 100 - Cedar Knolls, NJ 07927
Office - Fax
Email:Rajesh. -
About Artech Information Systems LLC
Artech is an employer-of-choice for over 5,500 consultants across the globe. We recruit top-notch talent for over 65 Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us!
Want to read more about Artech?
Clickhereto visit our website or click on the following links to read what others are saying about us:The Wall Street Journal,Forbes (1)(2),BusinessWire,Entrepreneur,Better Business Bureau,Hoovers,Diversity Careers(1)(2),The Artech Circle,NJTVOnline, andSIA: Above the Crowd.
Connect with Artech through Social Media
Learn more about our company including the latest events at Artech, new job opportunities, jobseeker tips, and more. Follow us onFacebook,Google+,LinkedIn,Pinterest,Twitter, andYouTubeEstimated Salary: $20 to $28 per hour based on qualifications.
Artech Information Systems, LLC
Reference # : 14-31061 Title : Clinical Research Specialist I
Location : Minneapolis, MN
Experience Level : Start Date / End Date : 09/08/2014 / 04/30/2015
Description
Job
Summary:
Company: Artech Information Systems LLC
Job Title: Clinical Research Specialist
Job ID: 45003
Location: Minneapolis, MN
Duration: 8 Months
Job Duties :
Assists with successful conduct of assigned studies consistent with R&D and Marketing plans.
Assists in preparation of study materials and training of investigators, center staff and Healthcare field staff.
Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents.
Reviews clinical data/information and oversees data correction.
Assists study managers in providing interim and final reports and presentations.
Assists study manager in writing PMA Clinical Reports.,Reviews and approves center activation documents.
Work with the Clinical Study Manager to satisfy applicable regulatory standards.
EDUCATION/EXPERIENCE REQUIREMENTS:
BS degree, 1-3 years' experience with clinical site management, 1-3 years clinical & regulatory documentation experience and 1-3 years industry experience.
Manger would like experience with CTMS and RAD but it is not a requirement.
POSITION DESCRIPTION:
Works under the supervision of the study manager/project manager of a Humanitarian Device Exemption (HDE) to satisfy applicable clinical and regulatory requirements and internal requirements for managing the study/HDE. Major deliverables are reviewed to ensure clinical and business requirements are met.
POSITION
Responsibilities:
Under the direction of the study manager, the CRS will assist with review and writing of clinical plans, study/project work instructions and guidelines, as well as performing activities and generating reports for one or more significant subparts of the study (e.g. monitoring, data management, adverse events, deaths, protocol deviations, legal agreements, study training, patient informed consents, clinical document management).
Assists in the development of the Clinical Investigational Plan, Clinical Management Plan, Data Management Plan, study training materials, and study reports in consultation with the study manager, clinical team, and investigators.
Assists with site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
Responsible for limited site monitoring under the direction of more senior level CRAs (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, and company standards, guidelines and policies.
Prepare accurate and timely monitoring reports and follow action items through resolution.
Ensure accurate inventory accountability of investigative product at assigned clinical sites.
May participate in process improvement initiatives.
Assists in ensuring site activities in line with milestones (i.e. startup, recruitment, closeout, etc.) and implement contingency plans as needed.
Responsible for accurate and timely adverse event reporting during the study.
May ensure site adherence to FDA, Regulatory, IRB and Healthcare requirements.
Work with investigators to quickly and effectively resolve problems.
Required Skills:
Education Level: Undergraduate Degree
General Experience in a Clinical Study Research Environment: 1 - 3 Years
General Experience in a Health Care or Business Related Field: 1 - 3 Years
Knowledge of Medical Terminology: Good
Oral Communication: Good
PC Experience : Data Entry
PC
Experience: Internet Usage
Software Application Knowledge: MS Outlook
Windows 2000, MS Excel, MS PowerPoint
Travel: 0-10%25%20Travel
Written Communication: Good
Rajesh Kumar
Sr.Associate Staffing
240 Cedar Knolls Road, Suite 100 - Cedar Knolls, NJ 07927
Office - Fax
Email:Rajesh. -
About Artech Information Systems LLC
Artech is an employer-of-choice for over 5,500 consultants across the globe. We recruit top-notch talent for over 65 Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us!
Want to read more about Artech?
Clickhereto visit our website or click on the following links to read what others are saying about us:The Wall Street Journal,Forbes (1)(2),BusinessWire,Entrepreneur,Better Business Bureau,Hoovers,Diversity Careers(1)(2),The Artech Circle,NJTVOnline, andSIA: Above the Crowd.
Connect with Artech through Social Media
Learn more about our company including the latest events at Artech, new job opportunities, jobseeker tips, and more. Follow us onFacebook,Google+,LinkedIn,Pinterest,Twitter, andYouTubeEstimated Salary: $20 to $28 per hour based on qualifications.
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