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Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
The PI is responsible for the safety of subjects who participate in clinical trials and for executing the study according to the IRB-approved protocol and applicable FDA and GCP regulations.
Pre-Study:
·Review protocol and Investigator Brochure for subject safety, scientific, and operational feasibility of study. Provide input to sponsor as indicated.
·Complete FDA 1572 and financial disclosure forms.
·Attend study initiation meetings with sponsor.
·Communicate with Institutional Review Board during protocol approval process and subject safety issues.
·Explain study to subject and answer questions, ensure proper consent, and perform screening examination.
·Final review of all screening data and authorization of subjects to be enrolled in the study.
During/Post Study:
·Perform scheduled per protocol, and unscheduled per adverse event, physicals during study conduct.
·Manage adverse events/clinical evaluation of subjects and determine adverse event relationship to investigational product, severity, and etiology. Review pre-dose lab work, ECGs, and other study data and determine appropriate action plan based on these results. Review safety data with sponsor.
·Compose SAE and other reporting documents as indicated.
·Review and sign Case Report Forms and final Clinical Study Reports.
·Review all serious adverse events and SUSARs to the Sponsor and IRB within statutory timelines
·Data review of all end-of-study data to determine if re-checks are necessary
·Safety-monitoring – perform end-of-study physical exams and follow-up ongoing adverse events
·Case Report Forms review – review and sign all case report forms at end of study
·Assist in on-site client review of case report forms
Additional Responsibilities:
·Assist with identifying and maintaining a network of physician specialists to contract on studies.
·Present Celerion’s capabilities and experience during sponsor meetings and events.
·Assist in the design of study and time/event schedules involving special medical procedures
·Function as a medical/clinical informational resource for the site.
·Assist other departments with development of SOPs, training plans, etc.
·Facilitate emergency response training and review of clinical safety procedures.
\nQualifications
Celerion Values: Integrity Trust Teamwork Respect
Are you ready to join our team?
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
Full Time
Scientific Services
$58k-81k (estimate)
05/23/2024
07/22/2024
celerion.com
TEMPE, AZ
500 - 1,000
2010
Private
STEVE HURLEY
$200M - $500M
Scientific Services
Celerion is a Nebraska-based clinical research organization that develops and commercializes drug development and medical writing services for the pharmaceutical sector.
The following is the career advancement route for Principal Investigator positions, which can be used as a reference in future career path planning. As a Principal Investigator, it can be promoted into senior positions as a Compliance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Principal Investigator. You can explore the career advancement for a Principal Investigator below and select your interested title to get hiring information.