Headline

Talks about #clinicalresearch, #ClinicalResearchQualitycontrolandassurance, and #clinicaldevelopment

Location

Pune Division

Work experience

Clinical Research QA Coordinator at D. Y. Patil college of Ayurveda and Research Center, pune, Aug 2023 - Present · 2 yrs 11 mos, Pune, Maharashtra, India, • Clinical Trial Documentation, Preparation, Periodic QC, QA. • Clinical Trial Startup to Closeout document management. • QA of ongoing clinical Trial. • Ensure that all processes contributing to the performance of a clinical trial are conducted properly. • work with internal teams and external regulatory agencies to register products (drug, biologics, medical device, in vitro diagnostics) that are safe and effective. • Making discussion according to regulatory guidelines issuing FDA and regulatory rules and regulations, or following regulatory orders for Ayurveda Products and includes promulgating is authorized or required by law, and any action which is required or authorized to be performed before, after, or in connection with, such determining, making, prescribing, issuing, or promulgating. • Working with internal teams and external regulatory agencies and with collaboration with FDA to register products (Ayurveda Products) that are safe and effective. • Coordinating a combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information permissions, licenses, or authorization granted by a Government, state agency or Regulatory Authorities and FDA to an individual or business entity permitting the manufacturing of a product, delivery of a service, development of a project or other similar undertakings. • Prepare and assist in preparing annual reports and quality trending reports. • Ensure regulatory rules are communicated through corporate policies and procedures. • Utilize guidance documents AYUSH standards. • Ensure that conduct of management of investigator, vendor, facility, and system audits are conducted. • Communicate any critical compliance risks noted from these activities to senior management.

Clinical Research Coordinator at Natasha Eye Care and Research Centre, Jan 2023 - Aug 2023 · 8 mos, Pune, Maharashtra, India, • Site identification, evaluation, and preparation (PSSV). • Performing regulatory, start-up, and maintenance activities according to applicable regulations, SOPS, and working instructions. • Notifying the site with regular updates on the protocol, IB, ICF, and patient materials and providing the green light upon IRB submission. • Collaboration with internal and external (e.g. site personnel, IRBs, etc.) stakeholders to deliver maintenance support activities during the clinical trial. • Coordinated with CRAs during the site Selection Visit (SSVs), site Initiation visit (SIVs), on-site Monitoring visits (IMVs/SMVs), Site Close-out Visits, Onsite Sponsor visits, and with EC Members during EC Inspection for multiple studies at multiple sites. •Clinical operations, Clinical site initiation, Clinical Data Management document Review, Electronic trial master file (e TMF), Trial Master File (TMF), Good Clinical Practice (GCP). • Training on ICH-GCP NIDA Clinical Trials Network Certificate of Completion course GOOD CLINICAL PRACTICE on 15 Feb 2023. • Training on e-TMF Reader (v1.0) and e-TMF Editor (v1.0) from TransPerfect’s Trial Interactive which compliant 21 CRF part 11 on 17 and 18 Jul 2023 respectively.

Education

Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance, Dry lab, MITCON Biotechnology & Pharmaceutical Center, Pune

Master's degree, Biodiversity and conservation management, Stanley Ind