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Clinical Trial Associate

System One

rockville, MD

System One
JOB DETAILS
LOCATION
rockville, MD
POSTED
10 days ago

Description

 
Job Title: Clinical Trial Associate - Remote 
Location: Remote - East Coast  
Type: 12+ Month Contract  

Biotech Company is looking for a Clinical Trial Associate to support Ophthalmology clinical studies!  
Requirements: 
  • Bachelor's Degree 
  • 2 years of experience supporting Clinical Trials with a Biotech/Pharma Company or CRO 
  • Experience utilizing Veeva Vaults required 
  • Knowledge of clinical trial processes and procedures from start up through closeout, GCP/ICH guidelines 
  • Ophthalmology experience a huge plus!  
  • Great communication skills, able to work in a cross-functional environment  
 Responsibilities:   
  • Coordinate the logistical aspects of clinical trials ensuring Good Clinical Practice (GCP) and study protocols are met 
  • Point of contact for the clinical trial team and study site  
  • Assists in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids), preparation of training workshops and meeting materials 
  • Develop study tracking tools, maintaining tracking spreadsheets/databases and providing routine reports/dashboards to study team members
  • Tracks essential documents and maintains/reviews the eTMF under the guidance of a CRA of CPM.
  • Assists with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release
  • Participates in co-monitoring visits or other site visits based on experience and training provided by and under guidance of the sites’ assigned Clinical Research Associate (CRA) or designee
  • Assists the CRA with the flow of data, including but not limited to facilitating resolution of queries under guidance of CRA or Clinical Project Manager (CPM)
  • Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports)
 
 Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

About the Company

System One logo

System One

With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:

  • Scientific staffing for hard-to-find skills

Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.

  • Clinical lifecycle recruiting

From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.

  • Equipment calibration, maintenance and validation

Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.

  • National healthcare recruitment

Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.

COMPANY DETAILS
COMPANY SIZE
500 to 999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/