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Clinical Project Associate - I
Ref No.: 18-12052
Location: Seattle, Washington
Start Date / End Date: 09/05/2018 to 02/04/2020
Job Title: Clinical Project Associate - I
Duration: 17 months
Location: Seattle, WA- 98102
 
 
Job Description:
 
  • The position entails work under general supervision for routine tasks and with detailed instructions on new assignments.
  • Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
  • Processes drug shipments, drug returns, and assists with in-house drug reconciliation.
  • Orders and maintains inventory of clinical supplies. Orders and ships case report forms.
  • Assists with development of documents for site binders.
  • Assembles and prepares distribution of site binders.
  • Serves as CTMA back up providing verbal and written communication with study personnel.
  • Under close supervision reviews and participates in the quality assurance of data or documents.
  • Arranges meeting logistics.
  • Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks.
  • May assist with monitoring visits under the direct supervision of senior staff. Travel may be required.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Must be familiar with Word, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.
  • Must be able to work both independently and as part of a team.
 
Specific Responsibilities and Skills for Position:
 
  • Client, Inc. is a research-based biopharmaceutical company founded in 1987.
  • Together we deliver life-saving therapies to patients in need.
  • With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
  • Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.
  • Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
  • By joining Client, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases
 
Clinical Project Assistant (CPA)
 
Specific Responsibilities and Skills for Position:
 
  • Carries out routine tasks under general supervision for routine tasks, with detailed instructions for new assignments related to Client, Collaborative (CO), Investigator Sponsored Research (ISR) Studies, and compassionate use programs as required - Tracks and prepares study-specific information utilizing databases, spreadsheets, and other tools
  • Reviews and participates in the quality assurance of data or documents.
  • Arranges meeting logistics, agendas, and responsible for producing minutes for designated studies and meetings.
  • Interacts with other departments, as directed, to complete assigned tasks .
  • Serves as back up for CTMA providing verbal and written communication with study personnel
  • Assists with development of documents and standard forms.
  • May be responsible for TMF maintenance for designated studies.
  • May serve as a resource within Clinical Operations for clinical trial systems used for managing clinical trials and publications
  • May act as subject matter expert and owner of departmental administrative processes 
  • Travel may be required
 
Knowledge:
 
  • Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, GCP, and familiarity with standard clinical operating procedures
  • Must be familiar with Word, PowerPoint, and Excel
  • Excellent verbal and written communication skills
  • Must be able to work both independently and as part of a team
 
Experience and Skills:
 
  • Typically requires a BS or BA in a relevant scientific discipline
  • Registered Nurse with relevant experience (2 or 3 year certificate)
 
Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331