Clinical Research Specialist
hace 6 días
Job Summary
At Icon, we are seeking a highly skilled Regional Clinical Scientist to join our team. This role will provide scientific and clinical support for ongoing early and late stage clinical trials, with a focus on protocol-specific, in-life clinical data monitoring activities. The successful candidate will work closely with the Study Medical Monitor/Study Clinical Scientist and other cross-functional team members to support clinical study execution and clinical data monitoring.
Key Responsibilities
Support Study Clinical Scientist in medical surveillance and medical monitoring activities under the guidance of the Medical Monitor
Conduct daily medical surveillance of laboratory & ECG alerts, including review of eligibility criteria as appropriate
Provide analytical support of clinical trial data, including assessment and follow-up of issues relating to protocol conduct and/or individual subject safety
Gather, review, and provide preliminary assessments of medical surveillance events to the Study Clinical Scientist and the Study Medical Monitor
Generate study safety events trackers, periodic medical monitoring reports, and safety reviews in line with the needs of the study
Participate in cross-functional study execution team activities relating to clinical data review
Contribute to ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Monitor/Study Clinical Scientist as applicable
Interact with internal and external stakeholders (study sites, vendors, etc.) in support of clinical trial objectives related to subject safety and clinical data monitoring; respond to or triage medical and safety-related questions for appropriate actions
Perform other duties as assigned related to clinical programs
Requirements
Life sciences degree (BS, MS, or Ph.D.) with clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting
Experience in analysis and interpretation of clinical data (including safety and efficacy); working knowledge of GCP and clinical trial execution
Experience working with clinical trial sites
Experience in all stages of drug development
Ability to make independent, timely, and appropriate decisions
Ability to handle multiple projects at a time and have a strong attention to detail
Excellent oral and written communication skills and solid computer/analytical skills
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
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