Clinovex Clinical Research Solutions Pvt Ltd.
Kochi, Kerala
CLINICAL RESEARCH ASSISTANT
From ₹20,000 a month
Full Job Description
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 Analysis: Support analysis of research data, including statistical analysis and interpretation of study findings.
Documentation and Reporting: 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.
