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Clinical Research Associate

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POST DATE 9/8/2016
END DATE 10/28/2016

Shire Pharmaceutical Lexington, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
13951BR
Location
Lexington, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Bachelors Degree
AJE Ref #
576117285

JOB DESCRIPTION

Job Description
PRIMARY ROLE:
Responsible for assisting and providing support to the members of the clinical operations project team (i.e. Clinical Project Managers, Associate Directors, or Directors), in order to facilitate the management of pre- and post-approval clinical trial processes including planning and execution of in-house or outsourced clinical trials. The Clinical Trial Associate (CTA) assists in the supporting the conduct of trials and may be responsible for managing specific study and operational tasks. The CTA performs work within established protocols under general supervision.

RESPONSIBILITIES:
40%: STUDY START UP
Facilitate CDA & Contract Execution Process (Routing and tracking of study specific contracts)
Manage study specific PO Creation
Collaborate with Study Manager and CRO to ensure accurate study specific CTMS setup and data feeds
Liaise with Transparency group to ensure Clintrials.gov is updated accordingly
Participate in creation and distribution of sponsor specific study aides/materials and communications
Key point person for R&D select background checks
Collate documents required for the EC/IRB/HA submissions

20%: STUDY MAINTENANCE
Assist Clinical Study Manager in tracking study related activities which are not appropriate to be outsourced
Agenda distribution & minute taking for internal study team meetings
Support SUSAR distribution
Maintain internal & external contacts lists in CTMS
Facilitate contract execution & study related PO creation for any change orders

25%: DEPARTMENTAL TASKS:
Maintain knowledge and act as team super user for related systems (e.g. CTMS, R&D Select, PO creation, Sharepoint)
Maintain up to date training record attending internal/external training as necessary
Participate in inter-departmental workgroups to create or enhance processes
Take on career developmental activities/tasks as necessary

15%: STUDY CLOSE OUT
Assist study team with preparation for audits/inspections
Assist study team in close out in CTMS
Liaise with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly

EDUCATION & EXPERIENCE REQUIREMENTS:
Bachelor's degree required
Minimum 0-2 year's experience in relevant field (eg. Clinical Site, CRO, Sponsor or Clincal trial Vendor)

OTHER JOB REQUIREMENTS:
Available for up to 10% domestic and/or international travel

ABOUT SHIRE:
Shire's BRAVE culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.