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Contract Clinical Research Associate
Job#: 187610
Positions: 1
Posted: 05/06/2013
Job Type: Contractor
Location: US - Field Based CRA
Department: Clinical Operations
Category: Clinical Ops
Salary: Commensurate with Experience
Benefits: No Benefits
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Job Description

Position Summary:

The Clinical Research Associate (CRA) is responsible for assisting the clinical study team in the design, execution and reporting of clinical studies. The CRA will be responsible for oversight and monitoring of CRO activities and for reviewing monitoring trip reports to ensure that the program supports upper management strategies and meets GCP and SOP requirements.  He/she is also responsible for maintaining all study related documents and correspondences.

CRA will be field based within the Continental US

Essential duties & responsibilities:

  • May serve as Clinical Trial Leader for selected trials - lead multifunctional team through clinical studies activities, ensures that program supports upper management strategies and meets GCP and SOP requirements, and maintains all study related documents and correspondences.
  • Assist in procuring and managing contracts with CROs and study vendors. Oversee and monitor CRO activities and review monitoring trip reports.
  • Collaborate with medical experts, clinical study sites, and CROs as appropriate.
  • Responsible for site management including start-up activities, routine monitoring and close-out activities.
  • Assist development of clinical trial protocol summaries, protocols, and informed consent documents.
  • Prepare and implement project specific training programs and training materials for internal and external staff.
  • Work with multidisciplinary project teams in preparing and implementing clinical development plans and provide clinical research expertise in support of other departments and line functions.
  • Participate in development of integrated clinical study reports to ensure accuracy, scientific excellence, and congruence of message between studies in a project.
  • Contribute to preparation of IND and other regulatory documents and submissions.
  • Review of clinical documents and templates.
  • Develop knowledge related to projects of study indications and therapeutic areas to better interact with investigators and external study coordinators.
Skills/Requirements

Core Competencies / Knowledge & Skill Requirements

  • Strong proficiency with Microsoft software (Word, Excel, PowerPoint and Outlook).
  • Excellent attention to detail, organizational and time management skills
  • Can prioritize and coordinate workload with minimal supervision.
  • Strong verbal, written, and communication skills.
  • Ability to work as part of a team and within a multidisciplinary  environment.
  • Has a basic understanding of budgeting and fiscal management of clinical trials
  • Posses a general knowledge of pharmaceutical industry R&D; in particular design and operational execution of clinical trials
  • Posses a good understanding of Good Clinical Practices (GCP).


Education, Experience & Training Required

Experience and Education (minimums)

  • Bachelors of Science degree.
  • 10 years of relevant clinical experience in the pharmaceutical industry/Oncology.
  • Excellent oral and written communication skills, strong leadership skills, self-motivated, team-player, adaptable to a dynamic environment.
  • Familiarity with the drug development process (including manufacturing and regulatory aspects) and medical/scientific writing experience preferred.
  • Ability to adapt to changing needs of the program.
  • Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations.
  • Good understanding of clinical study budgeting and the drug development process.
  • Knowledge of concepts of clinical research and drug development.

 

Communication & Interpersonal Skills
-Written:  excellent
-Verbal:  excellent
-Interpersonal: excellent

 

Significant Contacts
-Internal – business partners across all functional areas and departments
-External – vendors (CROs, Drug Depots, Contract Monitors, etc.), consultants


Essential Functions – Physical Position Requirements: Machines and/or Equipment Used

-PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint.)
-Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
-Ability to work on a computer up to 7 hours a day.
-Regularly required to sit for long periods of time, and occasionally stand and walk.
-Regularly required to use hands to operate computer and other office equipment.
-Close vision required for computer usage.
-Occasionally required to stoop, kneel, climb and lift up to 25 pounds.
-Up to 25% Domestic Travel, Occasional International Travel


Working Conditions
Work independently

Standard office environment without unpleasant or hazardous conditions.  Work entails typical physical demands involved in office work.

NOTE: As part of its pre-employment screening process, Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position.  This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned.

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