Senior Clinical Research Associate
- 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.
- 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