Compliance Specialist

2 weeks ago


kannur, India beBeeClinical Full time

Job Title: Compliance SpecialistThis role involves ensuring the quality and integrity of clinical trial data through site audits, documentation review, and adherence to protocols, regulations, and industry standards.Conduct audits of clinical research sites across various phases.Review case report forms (CRFs), informed consent forms, and regulatory documents.Identify and report audit findings; recommend corrective actions.Support site staff with compliance guidance and training.Prepare audit reports and follow up on implementation.The ideal candidate will have a Bachelor's degree in life sciences, nursing, pharmacy, or a related field, along with 10-12 years of experience in clinical research, including auditing and quality assurance expertise. Knowledge of GCP, ICH guidelines, and FDA/EMA regulations is essential. Strong communication, analytical, and organizational skills are required, and ability to travel is necessary.This position involves significant travel to clinical sites, a combination of remote and field work, and flexible scheduling to accommodate audits. Desired qualifications include Clinical Research or Quality Auditing certification and experience with electronic trial master files (eTMF) and electronic data capture (EDC) systems.A key aspect of this role is collaborating with cross-functional teams to ensure seamless execution of clinical trials and maintaining the highest standards of compliance.



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