Are you an experienced Clinical Research Associate (CRA) with expertise in Oncology PK studies? CBCC Global Research is hiring for the role of CRA/Senior CRA in Pune, Bengaluru, and Hyderabad. If you have 3-8 years of monitoring experience and a strong background in patient-based PK studies, this could be the perfect opportunity for you. Read on to learn more about the job details, responsibilities, and how to apply.
Job Highlights
- Position: Clinical Research Associate (CRA/Senior CRA)
- Experience Required: 3-8 years in monitoring, with Oncology PK studies experience mandatory
- Locations: Pune, Bengaluru, Hyderabad
- Job Code: CBCC/IND/CRA (Mention this in the subject line of your application)
- Pre-Requisite Skills: Minimum 2 years of onsite monitoring experience; patient-based PK studies experience preferred
- Application Email: career@cbcc.global
Key Responsibilities
As a Clinical Research Associate at CBCC Global Research, you will:
- Manage clinical trials and patient-based PK studies at various sites.
- Ensure effective communication with sites and stakeholders.
- Prepare for site visits and assist in developing project plans.
- Handle back-office monitoring and centralized monitoring activities.
- Coordinate with sites to resolve data clarification forms (DCFs).
- Support site activation by preparing checklists and ensuring compliance.
- Perform other duties as assigned by the Project Manager (PM), Head-PM, and DO.
Technical Experience Required
To excel in this role, you should have:
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- Regulatory Awareness: Knowledge of GCP, NDCT rules, COVID guidance, RECIST, and USFDA/EMA guidelines.
- Therapeutic Knowledge: Strong understanding of therapeutic areas to manage studies effectively.
- Ethics Committee & Informed Consent: Familiarity with ethics committee requirements and informed consent processes.
- Adverse Event Handling: Awareness of AE/SAE documentation and submission requirements.
- Trial Phases & BA/BE Studies: Understanding of phase trials, bioanalytical/bioequivalence studies, and site requirements.
- Site Selection & Monitoring: Expertise in site selection, onsite/remote monitoring, and handling site-specific issues.
- Patient Recruitment: Ability to address and overcome patient recruitment challenges.
- EDC Platforms & IP Handling: Knowledge of electronic data capture (EDC) systems and investigational product (IP) handling.
How to Apply
If you meet the eligibility criteria and are excited about this opportunity, send your application to career@cbcc.global. Don’t forget to mention the job code CBCC/IND/CRA in the subject line of your email.
