RESEARCH ASSOCIATE JUNIOR

As a fresher in the field of research and regulatory affairs, you will be responsible for completing appropriate role-specific training to perform job duties. Under supervision, you will assist in various administrative tasks to support team members in project execution. This may include running system reports, maintaining meeting minutes, preparing and distributing status reports, creating and managing study documents, and more. Your role will also involve updating and maintaining systems within project timelines and per project plans. Ensuring the accuracy and completeness of source documents, CRFs, Investigator Site File, and other study-related documents according to ICH-GCP guidelines will be crucial. Additionally, you will be responsible for completing the eCRF and maintaining Investigational Product integrity based on specific temperature requirements. Furthermore, you will play a vital role in preparing for site qualification visits, initiation visits, monitoring visits, and site close-out visits. Organizing ethics committee meetings, completing review forms, and submitting all study-related documents to EC will also be part of your duties. You may need to coordinate with local and central labs, assist in Safety Reporting within required timelines, contribute to patient selection and recruitment processes, and support the Informed Consent Process. To excel in this position, you should possess basic knowledge of applicable research and regulatory requirements such as ICH GCP and relevant local laws, regulations, and guidelines. Proficiency in MS Applications like Microsoft Word, Excel, and PowerPoint is essential. Strong written and verbal communication skills in English, effective time management abilities, and a results-oriented approach to work delivery will be critical for success. Moreover, you should be capable of establishing and maintaining effective working relationships with coworkers, managers, and clients. Strong listening and phone skills, as well as good data entry abilities, are also required to fulfill the responsibilities of this role. Candidates from the years 2016 to 2019 with educational backgrounds in B.Tech, M.Tech (Biotechnology), MSc (Biotechnology, Microbiology, Biochemistry), B.Pharm, M.Pharm, Pharm D, MSc, and BSc (Life Science: Bioinformatics, Biomedical Engineering, etc.) are encouraged to apply for this position. This job is suitable for individuals who can work from Monday to Friday at the specified in-person work location.,