US
0 suggestions are available, use up and down arrow to navigate them
PROCESSING APPLICATION
Hold tight! We’re comparing your resume to the job requirements…
ARE YOU SURE YOU WANT TO APPLY TO THIS JOB?
Based on your Resume, it doesn't look like you meet the requirements from the employer. You can still apply if you think you’re a fit.
Job Requirements of Clinical Trial Consultant II:
-
Employment Type:
Contractor
-
Location:
Cambridge, MA (Onsite)
Do you meet the requirements for this job?
Clinical Trial Consultant II
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Title: Clinical Trial Consultant II
Duration: 12 Months+ Possible Extension
Location: Cambridge, MA (Hybrid- 2 Days onsite)
Pay Range: $55-$60/hr
Job Product:
Responsible for case processing and/or QC of clinical trial ICSRs and post-market case processing from sanctioned countries.
Key Responsibilities:
Duration: 12 Months+ Possible Extension
Location: Cambridge, MA (Hybrid- 2 Days onsite)
Pay Range: $55-$60/hr
Job Product:
Responsible for case processing and/or QC of clinical trial ICSRs and post-market case processing from sanctioned countries.
Key Responsibilities:
- Triage, Intake, case entry and QC of ICSRs originating from client sponsored studies or other assigned cases
- Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
- Perform retrospective quality checks on processed cases
- Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
- Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
- Provide investigation details into late regulatory reporting of CT cases
- Knowledge of Global and local safety regulations
- Excellent written and verbal communication skills
- Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
- Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
- Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
- Education : Bachelors degree in science or healthcare related field
- Experience : 4+ years experience in pharmacovigilance
Get job alerts by email.
Sign up now!
Join Our Talent Network!