Coordinator- Prospective Research (Remote)
Wayne, PA 
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Job Description
Coordinator- Prospective Research (Remote) (000022UK)

About Xcenda"

Xcenda, a business unit of AmerisourceBergen Corporation, is an integrated, world-class health care consulting organization focused on value, reimbursement and patient access. For more than 2 decades, Xcenda has helped global biopharmaceutical companies as well as emerging early-phase firms successfully commercialize innovative medical treatments and technologies in complex and cost-constrained global markets. Our broad, yet strategically connected, array of consulting services supports all phases of the product lifecycle. Our experts provide customized solutions and innovative approaches that discover and communicate the value of pharmaceuticals and other healthcare technologies.

As a member of the Xcenda team, you will be working, learning, and teaching alongside intelligent, collaborative, and experienced professionals who are inspired by what they do and highly motivated to make a difference. Whether you join us in one of our core locations: Tampa, Charlotte, San Francisco or Washington D.C. - or work remotely like many of our Associates, you will experience what we call "Commitment that Counts" - a mindset and attitude we all share. It is the commitment that we have to our clients, to each other, and to the patients we serve that makes Xcenda such a special and unique organization and more than just a place to work. We are a group of highly motivated people -- all dedicated experts in what we do --- who value accountability, collaboration, customer focus, innovation, integrity, and passion. We believe life is meant to be pursued and enjoyed through creative thinking, ethics and bringing an entrepreneurial spirit to everything we do.

Share in our commitment to excellence. Play a vital role in helping patients gain access to life-saving therapies. Take the next step today and learn how you can join us.

The Coordinator, Prospective Research is responsible for supporting the conduct of prospective studies in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Xcenda Standard Operating Procedures.

PRIMARY DUTIES AND RESPONSIBILITIES:

The responsibilities of the Coordinator, Prospective Research may include, but are not limited to the following:

  • Provides support to the project team and study sites from study start-up through close-out to ensure adherence to protocol and regulations
  • Calculation, management and tracking of site and patient payments across all studies
  • Provides support for site selection, outreach and initiation
  • Conducts source data verification for transcribed data
  • Works with sites to resolve data queries
  • Works with sites to collect required regulatory documents
  • Creates and maintains the electronic Trial Master File (eTMF) in the internal and client clinical trial management systems (CTMS), ensures that regulatory documents are acquired, complete, and compliant
  • Provides support for IRB submissions, amendments and annual updates
  • Completes beta testing for electronic data capture (EDC) tools
  • Facilitates the distribution of supplies and forms to sites
  • Tracking of Sunshine Reporting and associated tasks
  • Generates and distributes weekly recruitment updates and monthly study newsletters
  • Ensures adherence to protocol, ICH, GCPs, SOPs
  • Other duties as assigned

Qualifications
  • Bachelor's degree in life-sciences or related field preferred
  • Minimum of 2 years clinical research experience in the pharmaceutical or medical device industry
  • Working knowledge of GCPs and Federal Regulations
  • High level of organization and self-motivated to manage multiples sites and projects simultaneously
  • Previous experience with electronic data capture systems, eTMF and CTMS, is preferred
  • Proficiency in MS Word, MS Excel, MS PowerPoint
  • Excellent written and oral communication skills

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

  • Work independently and proactively
  • Strong organizational skills
  • Detail oriented
  • Strong work ethic
  • Positive attitude
  • Functions as a team player
  • Work efficiently on all tasks within the allotted number of hours by deadline
  • Excellent verbal and written communication skills
  • Ability to manage a diverse project load
  • Produce positive results in a high-pressure environment
  • Prioritize tasks and complete assignments in a thorough and competent manner
  • Recognize areas to increase efficiency and contribute solutions


Organization: Xcenda


Equal Opportunity Employer/Minority/Female/Disability/Veteran

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2+ years
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