Clinical Operations Lead
A
AlimentivClinical Research
DelhiFull-TimeLead
Salary not disclosed
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Job Details
- Experience
- College diploma/degree: 7-9 years; Undergraduate university degree: 4-6 years.
- Required Skills
- MS Office
Requirements
- College diploma/degree with 7-9 years of related experience or Bachelor's degree with 4-6 years of experience.
- Minimum 3 years of CRA experience.
- Substantial ongoing job-related training.
- Strong experience with EDC (Electronic Data Capture) systems.
- Proficiency with MS Office suite.
- Demonstrated knowledge of ICH-GCP guidelines and local clinical research regulations.
- Ability to critically understand clinical research documents and perform high-quality report writing.
- Highly effective interpersonal, organizational, and task-driven skills.
- Health Sciences, Life Sciences, or Nursing specialty preferred.
- SoCRA or ACRP certification/designation preferred.
Responsibilities
- Provide overall oversight of regional CRAs to ensure site compliance with study protocols and ICH-GCP guidelines.
- Conduct monitoring support visits (co-monitoring) to aid in site and CRA performance.
- Oversee regional startup, feasibility, and monitoring visit reporting for quality and compliance.
- Implement enrollment and recruitment strategies and monitor performance metrics.
- Act as the primary project liaison, conducting regular CRA calls and providing status updates to Study Sponsors.
- Develop study tools, training materials, and monitoring plans for site and CRA use.
- Contribute to financial project management tasks including site payment reviews and revenue recognition inputs.
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