BHAGWAN AVHAD

• Documentation control and management in clinical trial, bioanalytical, or diagnostic laboratories, including preparation, review, issuance, version control, archival, and retrieval of SOPs, manuals, formats, and records as per QMS requirements.
  
  Demonstrated experience in software validation and documentation. • Working knowledge of clinical database development, knowledge of R/ Python/ STATA.
• • Experience in review and control of SOPs, laboratory documents, LIMS, deviations, CAPAs, and ensuring compliance during receipt, testing, storage, and disposal of clinical trial samples.
  
  • Experience in supporting internal audits, sponsor audits, and regulatory inspections, including audit preparation and follow-up activities.
  • Ability to maintain accurate and complete laboratory and clinical trial records.
  
  • Familiarity with IMS and experience in NABL or ISO accreditation processes will be an added advantage.
  
  # Timely report generation, to track study progress, identify triggers of non-compliance.
• Oversaw compliance with regulatory standards, ensuring high-quality laboratory practices.
• Optimized lab operations through regular review of safety protocols, equipment maintenance schedules, and personnel training programs.

• Meeting Coordination and Communication: • Schedule, coordinate, and document clinical team meetings, site communications, and teleconferences; maintain meeting agendas and minutes.
• The role will be responsible for taking lead in data management for the clinical trial and ensure timely delivery of key tasks, while maintaining high quality standards, mentoring and development of the database/ scheduler and will serve as a point of contact for the sponsor.
• Will work closely with the study team, ensure compliance to data management standards and procedures; including data protection, data security and data backup plan.
• Familiarity with IMS and experience in NABL or ISO accreditation processes will be an added advantage.
  • Assist with the organization and execution of investigator meetings, including logistics, preparation of materials, and follow-up documentation.
• Experience in review and control of SOPs, laboratory documents, LIMS, deviations, CAPAs, and ensuring compliance during receipt, testing, storage, and disposal of clinical trial samples.

• Experience in supporting internal audits, sponsor audits, and regulatory inspections, including audit preparation and follow-up activities.
• Support budget tracking, invoice verification, and financial documentation coordination related to trial expenses and vendor contracts.

• The Senior Project Associate conducts monitoring visits for the assigned
  trial protocol and trial sites. Overall responsibilities are to ensure that the
  trial is being conducted in accordance with the protocol, standard
  operating procedures, good clinical practice, and applicable regulatory
  requirements.
  • Performs site monitoring throughout the trial which involves visiting the
  trial sites on a regular basis (site initiation to site closeout) in accordance
  with contracted scope of work.
  • Performs quality functions and executing quality programs (clinical
  operations, clinical laboratory) as per GCP/GCLP and regulations
  • Completes appropriate therapeutic, protocol and clinical research training
  to perform job duties.
  • Setting up the trial sites such that each center has the trial materials,
  including the trial drug while ensuring all trial supplies are accounted for
  • Administers protocol and related trial training to assigned sites and
  establishes regular lines of communication with sites to manage ongoing
  project expectations and issues.
  • May provide training and assistance to junior clinical staff.
  • Creates and maintains appropriate documentation regarding site
  management, monitoring visit findings and action plans by submitting
  regular visit reports and other required trial documentation.
  • Manages the progress of assigned studies by tracking regulatory/ IEC
  submissions and approvals, recruitment and enrolment, CRF completion
  and submission, and data query generation and resolution.
  • Verifying that data entered on to the CRFs is consistent with participant
  clinical notes (source data/ document verification)
• Optimized code quality and maintainability by conducting thorough code reviews and providing constructive feedback to peers.
• Ensured data integrity through regular backups, updates to security protocols, risk assessments, vulnerability scans, and continuous process improvements.

• Conducted laboratory tests and procedures with precision to support diagnostic accuracy.
• Maintained and calibrated laboratory equipment to ensure optimal operational functionality.
• Assisted in the preparation of specimens for analysis, adhering to strict safety protocols.
• Documented test results and maintained accurate records for compliance and quality assurance.
• Trained new staff on laboratory procedures and best practices to enhance team efficiency.
• Collaborated with healthcare professionals to facilitate effective patient care through timely lab results.
• Managed specimen sample handling, receiving, storage and inventory.
• Maintained lab by calibrating equipment and cleaning surfaces and items used.
• Enhanced laboratory efficiency by maintaining and organizing equipment, supplies, and samples.
• Prepared samples for centrifugation, aliquoting and preserving sample integrity.
• Assisted with support duties such as filling products, labeling products, testing samples and taking inventory.
• Prepared specimens for testing and analysis.
• Improved laboratory safety through regular inspection and maintenance of equipment, as well as adherence to safety guidelines.
• Maintained confidentiality of sensitive information pertaining to research findings, methodologies, or patient data when required by regulations or ethical standards.
• Tracked collected specimens by initialing, dating, and noting times of collection.
• Inspected laboratory equipment to maintain good working condition for optimal results.
• Trained new laboratory personnel to apply proper laboratory techniques and best practices.
• Set and oversaw quality assurance guidelines for laboratory work.
• Documented test results accurately, facilitating efficient patient diagnosis and treatment plans.
• Trained new staff on laboratory protocols and safety procedures to enhance team performance.

• Conducted routine laboratory tests to ensure accuracy and reliability of results.
• Maintained laboratory equipment, ensuring proper functioning and adherence to safety protocols.
• Recorded and analyzed test data, providing detailed reports for medical staff review.
• Assisted in developing standard operating procedures for laboratory processes and workflows.
• Collaborated with healthcare professionals to support patient diagnosis through accurate testing.
• Trained junior technicians on laboratory techniques and safety practices to foster skill development.
• Streamlined sample processing procedures, reducing turnaround times for critical test results.
• Cleaned and sterilized tools and equipment to maximize purity of specimens.
• Operated basic laboratory equipment such as balances, pH meter, colorimeter, spectrophotometer, autoclave and evaporator.
• Collected and performed analytical testing on in-process product.
• Participated in lab meetings and project presentations.
• Developed new protocols and improved existing laboratory processes.