RESPONSIBILITIES Complete appropriate role-specific training to perform job duties Under supervision, perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.) Under supervision, assist in updating and maintaining systems within project timelines and per project plans Maintaining the source documents, CRF’s, Investigator Site File and other study related documents according to ICH-GCP guideline Completing the eCRF Maintenance of Investigational Product according to the specific temperature. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits. Organizing ethics committee meetings Completing the review forms and submitting all study related documents to EC Coordinating with the local labs, central labs Assistance in Safety Reporting within the required timelines. Assistance in patient selection and recruitment Assistance in Informed Consent Process REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Basic knowledge of applicable research and regulatory requirements, i.e., ICH GCP and relevant local laws, regulations and guidelines Exposure to MS Applications including but not limited to Microsoft Word, Excel and PowerPoint Effective written and verbal communication skills including good command of English language Effective time management skills Results and detail-oriented approach to work delivery and output Ability to establish and maintain effective working relationships with coworkers, managers and clients Strong listening and phone skills Good data entry skills Required Experience, Skills and Qualifications MSc Biotechnology, Microbiology, Biochemistry B. Pharm, M. Pharm, Pharm D. MSc. Bsc. LifeScience: Bioinformatics, Biomedical Engineering ect.Job Types: Full-time, Internship Job Type: Full-time Salary: ₹211,274.00 - ₹456,705.00 per year Schedule: Morning shift Ability to commute/relocate: Kochi, Kerala Experience: total work: Freshers -1 year (Preferred) Job Types: Fresher, Internship Pay: ₹20,000.00 - ₹30,000.00 per month Education: Master's (Preferred) Work Location: In person
RESPONSIBILITIES Complete appropriate role-specific training to perform job duties Under supervision, perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.) Under supervision, assist in updating and maintaining systems within project timelines and per project plans Maintaining the source documents, CRF’s, Investigator Site File and other study related documents according to ICH-GCP guideline Completing the eCRF Maintenance of Investigational Product according to the specific temperature. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits. Organizing ethics committee meetings Completing the review forms and submitting all study related documents to EC Coordinating with the local labs, central labs Assistance in Safety Reporting within the required timelines. Assistance in patient selection and recruitment Assistance in Informed Consent Process REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Basic knowledge of applicable research and regulatory requirements, i.e., ICH GCP and relevant local laws, regulations and guidelines Exposure to MS Applications including but not limited to Microsoft Word, Excel and PowerPoint Effective written and verbal communication skills including good command of English language Effective time management skills Results and detail-oriented approach to work delivery and output Ability to establish and maintain effective working relationships with coworkers, managers and clients Strong listening and phone skills Good data entry skills Required Experience, Skills and Qualifications MSc Biotechnology, Microbiology, Biochemistry B. Pharm, M. Pharm, Pharm D. MSc. Bsc. LifeScience: Bioinformatics, Biomedical Engineering ect.Job Types: Full-time, Internship Job Type: Full-time Salary: ₹211,274.00 - ₹456,705.00 per year Schedule: Morning shift Ability to commute/relocate: Kochi, Kerala Experience: total work: Freshers -1 year (Preferred) Job Types: Fresher, Internship, Volunteer Pay: ₹20,000.00 - ₹30,000.00 per month Education: Master's (Preferred) Work Location: In person
Coordination : Coordinating study activities and timelines, scheduling participant visits, coordinating study procedures (e.g., laboratory tests, imaging studies), and ensuring compliance with regulatory requirements. · Data Analysi s: Support analysis of research data, including statistical analysis and interpretation of study findings. · Documentation and Reportin g: Assisting in the preparation of study-related documentation, including research protocols, informed consent forms, and regulatory submissions. Additionally, helping in the preparation of study reports, abstracts, and manuscripts for publication. · Regulatory Compliance : Ensuring compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and institutional policies throughout the conduct of the study. This includes maintaining study documentation, conducting internal audits, and participating in regulatory inspections as needed. · Collaboration : Collaborating with interdisciplinary teams, including physicians, nurses, laboratory personnel, and statisticians, to ensure the smooth conduct of clinical research studies. Additionally, communicating study progress and findings to stakeholders such as investigators, sponsors, and regulatory agencies. · Training and Education : Participating in ongoing training and educational activities related to clinical research, including protocol-specific training, GCP training, and professional development opportunities. · Adherence to Ethical Standards : Upholding ethical standards in the conduct of clinical research, including protecting the rights and welfare of research participants and maintaining confidentiality of study data. Required Experience, Skills and Qualifications BDS, MSc/Bsc Biotechnology, MSc/BscMicrobiology, MSc/Bsc Biochemistry B. Pharm, M. Pharm, Pharm D. MSc. Bsc. LifeScience: Bioinformatics, Biomedical Engineering ect.Job Types: Full-time, Internship Job Type: Full-time Schedule: Morning shift Ability to commute/relocate: Kochi, Kerala Experience: total work: Freshers -1 year (Preferred) Job Type: Fresher Job Types: Fresher, Internship Pay: From ₹20,000.00 per month Experience: total work: 1 year (Preferred) Work Location: In person