Vasta Bio-Informatics Pvt. Ltd. is a renowned organization specializing in bioinformatics, clinical research, and data management solutions. Based in Navi Mumbai, Maharashtra, the company is committed to advancing medical research by providing state-of-the-art clinical trial management and data services. With a focus on oncology-specific projects and a robust infrastructure for managing clinical trials, Vasta Bio-Informatics plays a vital role in the healthcare and life sciences industry.
Job Responsibilities
As a Clinical Research Associate (CRA) at Vasta Bio-Informatics Pvt. Ltd., you will be responsible for:
- Project and Operations Management:
- Managing designated clinical trials.
- Preparing trial-related documentation, such as protocols and Case Report Forms (CRFs).
- Ensuring the completeness and timely submission of data into various platforms like electronic CRFs, cancer research databases (CRDB), and other systems.
- Data Management:
- Tracking completed CRFs and ensuring they are entered into the database swiftly.
- Responding to queries generated during the data cleaning process in compliance with ICH-GCP guidelines.
- Ensuring trial conduct aligns with approved protocols and amendments.
- Quality Assurance:
- Participating in global meetings and conference calls to review the progress of clinical trials.
- Monitoring compliance with protocols and GCP procedures.
- Reporting deviations, violations, safety alerts, or quality issues to the sponsor.
- Regulatory Compliance:
- Completing all regulatory requirements as applicable.
- Maintaining strict adherence to security protocols, including safeguarding sensitive data and ensuring system security.
Qualification Requirements
Candidates applying for the Clinical Research Associate role must have:
- A Bachelor’s or Master’s Degree with a minimum of 1 year of experience in clinical trial management or protocols.
- Alternatively, 6 months of clinical trial experience with certification in Clinical Trials or Research.
- A strong preference for candidates with knowledge of oncology-specific terminology.
- Experience working with Electronic Data Capture (EDC) systems like Medidata RAVE, Oracle Inform, etc.
- Experience with industrial protocols and monitoring visits is highly valued.
Key Skills
To excel as a Clinical Research Associate at Vasta Bio-Informatics, you need the following skills:
- Clinical Research Expertise: Strong knowledge of ICH-GCP guidelines, clinical monitoring, and CRO processes.
- Data Management: Proficiency in managing clinical trial data and working with various data entry systems.
- Regulatory Affairs: Understanding of regulatory compliance and safety protocols.
- Technical Skills: Hands-on experience with computer systems and familiarity with EDC platforms.
- Communication: Excellent written and verbal communication skills.
- Multitasking and Time Management: Ability to work under pressure, multitask, and meet deadlines efficiently.
How to Apply
Interested candidates can apply for the position of Clinical Research Associate by submitting their resumes to the Vasta Bio-Informatics recruitment portal or via email. The deadline for applications is 29th November 2024
