Parexel

Senior Clinical Research Associate

Company
Parexel
Location
England (GB)
Salary
Competitive
Posted
08 Jul 2021
Closes
07 Aug 2021
Discipline
Clinical Research
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

ExecuPharm (a Parexel Company) are currently looking for an experienced Senior Clinical Research Associate to join us on a freelance/contract basis for 12 months.

Assigned to one of our key medical devices sponsors, you'll be responsible for covering clinical sites in England.

 

Primary Duties:

  • Serves as the primary monitoring point of contact for assigned clinical research sites.
  • Performs site development and training (supporting and coaching site personnel), site set-up, site monitoring (evaluation of site performance and identification of issues), and site close-out activities for assigned clinical research sites with designated program SOPs, Client expectations, clinical study protocols and GCPs.
  • Problem solves (including CAPA development where necessary) identified issues with appropriate escalation to S&N CSM or Clinical Operations Manager and/or designees
  • Assures protection of the rights, safety, and well-being of subjects, study integrity and data quality.
  • Performs activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, device accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution.
  • Facilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site file
  • Manages Central and Local IRB or EC submissions including; workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB or EC in conjunction with study team/Client/site staff as applicable.
  • Maintains awareness of site dynamics and able to motivate, persuade and educate site staff.
  • Complies with the Clinical Monitoring Plan and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the studies within the program.
  • Completes monitoring reports in compliance with requirements in the Clinical Monitoring Plan.

 

Skills:

  • Minimum 5 years of monitoring experience.
  • 1 year medical device experience in Orthopedic, Sports Medicine, or Wound care preferred.
  • MediData RAVE, EC submission experience preferred.
  • Demonstrates solid understanding of clinical research practices
  • Understands and is able to comprehend study protocols.
  • Possesses working knowledge of GCPs and other regulations governing clinical research

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