Clinical Research Associate > Recruteur inconnu > Joboolo FR :
Lieu : île / de / france
Additional Locations:
France:
Voisins le Bretonneux; France:
Ã?le:
de:
France
Diversity :
Innovation :
Caring :
Global Collaboration :
Winning Spirit :
High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high:
performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing :
whatever your ambitions.
Location:
France
Preferred area:
Paris area
About This Role
The ClinicalResearchAssociate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with company's divisions, through technology enablement, high:
touch customer service, study acceleration, and high:
quality data collection.
Driving principles and behaviors for this role are:
collaboration, accountability, innovation, adaptability, integrity and caring.
In all actions the CRA demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
The CRA monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.
The CRA also provides support in enrollment, follow:
up and closure of clinical trial activities through collaboration with Trial Operations, Regulatory Affairs and the Contract and Budget teams, and with divisional and regional clinical teams.
Key Responsibilities
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Source Verification:
Conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records.
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Communications:
Ensures clear written communication to clinical sites and project team members through monitoring reports, follow:
up letters, study memos and general correspondence.
Escalates serious issues as per company's escalation process when appropriate.
:
Training:
Ensures all site personnel is appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations.
Monitors and maintains site personnel list, qualification and training records.
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Compliance:
Ensures compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WIs, policies and procedures.
Ensures any identified site non:
compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview.
Support internal quality audits and regulatory inspections, as required.
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Event Reporting:
Ensures that all reportable events are identified, clearly documented and reported per protocol and per applicable requirements and regulations.
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Collaboration:
Participates in study:
specific meetings, teleconferences and training.
Collaborates with cross:
functional team members and study sites throughout all study phases.
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Documentation:
Manages study request/collection of relevant (i.e.
