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Healthtech • Biotech • Pharmaceutical
The CRA II/ SCRA conducts site management activities, monitoring compliance with protocols and regulations, ensuring data integrity, and supporting clinical studies from initiation to close-out.
Top Skills:
Good Clinical PracticeIch-Gcp
Healthtech • Biotech • Pharmaceutical
Lead interdisciplinary clinical research projects ensuring GCP/ICH compliance, deliverables, timelines, budgets, risk mitigation, TMF quality, client communications, business development support, and team leadership/mentoring.
Top Skills:
Prince Ii,Pmp,Good Clinical Practice (Gcp),Ich Guidelines,Tmf,Clinical Databases
Healthtech • Biotech • Pharmaceutical
Conduct site qualification, initiation, monitoring, management and close-out activities (on-site or remote) ensuring GCP/ICH and protocol compliance. Perform source document review, CRF verification, IP accountability, ISF/TMF reconciliation, documentation, and support recruitment/retention. Liaise with site staff and sponsors, support audits, complete training, and manage site-level timelines and deliverables. May perform chart abstraction and train junior staff in Real World Late Phase studies.
Top Skills:
Electronic Data Capture (Edc)Investigator Site File (Isf)Trial Master File (Tmf) Systems
Healthtech • Biotech • Pharmaceutical
The CRA II conducts site visits for qualification, initiation, monitoring, and closure, ensuring compliance with regulations and protocols, and managing site communications and activities throughout the study lifecycle.
Top Skills:
Good Clinical PracticeIch Guidelines
Healthtech • Biotech • Pharmaceutical
The CRA II/ SCRA will perform site management, monitor compliance with regulations, manage clinical data, and communicate with study sites and project teams.
Top Skills:
Electronic Data CaptureGood Clinical PracticeIch Guidelines
Healthtech • Biotech • Pharmaceutical
Perform site qualification, monitoring, and management activities for clinical trials, ensuring compliance with regulations and accuracy of data.
Top Skills:
Electronic Data Capture SoftwareGood Clinical PracticeIch Guidelines
Healthtech • Biotech • Pharmaceutical
Conduct site monitoring activities including qualifications, initiation, and compliance checks, ensuring adherence to protocols and regulatory standards.
Top Skills:
Good Clinical PracticeIch Guidelines
Healthtech • Biotech • Pharmaceutical
Perform site qualification, monitoring, and management, ensuring compliance with regulatory requirements and protocol. Maintain accurate documentation and support project objectives through effective communication and site liaison.
Top Skills:
Clinical MonitoringData CaptureElectronic Data CaptureIch-Gcp GuidelinesRegulatory Compliance
Healthtech • Biotech • Pharmaceutical
Manage interdisciplinary clinical research studies ensuring compliance with regulations, lead project teams, and maintain financial performance. Establish client relationships and oversee project deliverables.
Top Skills:
Good Clinical PracticeIch Guidelines
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