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Biospecimen Research Data Management Coordinator

0-2 years
Not Disclosed
10 Nov. 21, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🚨 We're Hiring! Join Our Team at Indoriv Clinical Private Limited! 🚨

Job Title: Biospecimen Research Data Management Coordinator 
Department: Biospecimen Research
Location: Kolkata 

😎 Job Description: 

The Biospecimen Research Data Management Coordinator will manage and maintain Clinical data and Biospecimen records, ensuring compliance with Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Indian Council of Medical Research (ICMR) guidelines. 

This role supports the coordination of Biospecimen-related research, focusing on data accuracy, security, and adherence to regulatory standards. 

The coordinator will interact with various stakeholders, including clinical sites, research teams, and regulatory bodies, to ensure smooth and efficient data collection, handling, and reporting processes.

🤠 Key Responsibilities: 

• Data Management: Extract, develop, manage, and maintain high-quality Clinical and Biospecimen data records, ensuring accuracy, consistency, and compliance with GCP, GDP, and ICMR standards. 
• Documentation & Compliance: Implement Good Documentation Practices to maintain complete, accurate, and traceable records for all Biospecimen-related activities. 
• Coordination & Communication: Liaise with clinical sites, research staff, and data management teams to coordinate data collection processes, including consent management, data entry, and Biospecimen tracking. 
• Assessing Nonconformance and Resolving Discrepancies: Conduct routine quality checks to verify data integrity and Biospecimen chain of custody. Address and resolve discrepancies promptly to maintain data quality. 
• Protocol Adherence: Assist in ensuring research protocols and standard operating procedures are followed meticulously, particularly in relation to Biospecimen handling, storage, and transportation. 
• Audit & Compliance Support: Prepare for and participate in internal and external audits, ensuring all data and records meet regulatory standards and are readily accessible. 
• Data Security & Confidentiality: Uphold high standards of data security and confidentiality in alignment with GCP guidelines and ICMR ethics to protect patient information.

🧐 Qualifications:

• Education: Bachelor’s or Master’s degree in Life Sciences, Biology, Clinical Research, Data Management, or related field. 

• Experience: 0–2 years of experience in clinical data management, biospecimen research, or a related area. 

• Technical Skills: Proficiency in data management software (e.g., REDCap, EDC systems), Microsoft Office Suite (Excel, Word). 

• Communication Skills: Excellent verbal and written communication skills, with an ability to work collaboratively with cross-functional teams and communicate complex data requirements clearly. 

If you are interested, kindly send your CV at hr@indorivclinical.com with Subject line 'Application for the post of Biospecimen Research Data Management Coordinator'. 🤞