Senior Clinical Research Associate

England (GB)
08 Jul 2021
07 Aug 2021
Clinical Research
Full Time
Contract Type
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.



  • 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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