RAVI KULKARNI

CUREENT RESPONSIBILITIES AT NORWICH CLINICAL SERVICES PVT., LIMITED

Pharmacist

• Receipt, Identification and Storage of Investigational Products.
• Dispensing of Investigational Products according to randomization schedule or as per protocol.
• Administration of Investigational Products to the study subjects.
• Archiving/Disposal/Return of Investigational Products.
• Accountability of Investigational Products at trial site.
• General maintenance of pharmacy, recording daily temperature and humidity of pharmacy equipments and pharmacy rooms. Cleaning of pharmacy.
• To prepare investigational product labels required for conduct of the study.
• Correspondence with the sponsor through project management team towards the matters related to Investigational products which includes quick response to sponsor queries, speedy update to the sponsor on IP related issues.
• Tracking the Investigational product shipments and review of temperature readings to ensure acceptable temperature range was maintained throughout the transit period.
• Regular tracking of the archived investigational products enabling timely destruction of Investigational products after the completion of archival period.
• Hands on experience in facing sponsor audits and regulatory audits.

Clinical Research Coordinator

• Monitoring of various clinical trial activities like subject Check-In, Check-Out, Sample draw, Sample segregation.
• Review Case report forms for completeness and feasibility before the study start.
• To review and verify the Investigator Site File, Informed consent documents, CRFs, Source Data and other clinical data for legibility, completeness and accuracy.
• To ensure quality control process throughout the trial period.
• Proven potential to solve clinical trial related issues independently as well.
• Well demonstrated hands on experience in checking the clinical trial data leading to identifying potential errors, if any and getting rectified the same.

Review of Informed Consent documents

• Hands on experience in experience in reviewing Informed consent documents in vernacular languages.
• Reviews Informed consent documents of Hindi and Kannada languages.
• Ensures accurate translation from English has been done.

RESPONSIBILITIES AT LOTUS LABS PVT., LIMITED

Pharmacist

• Receipt, Identification and Storage of Investigational Products.
• Dispensing of Investigational Products according to randomization schedule or as per protocol.
• Administration of Investigational Products to the study subjects.
• Archiving/Disposal/Return of Investigational Products.
• Accountability of Investigational Products at trial site.
• General maintenance of pharmacy, recording daily temperature and humidity of pharmacy equipments and pharmacy rooms. Cleaning of pharmacy.
• To prepare investigational product labels required for conduct of the study.
• Correspondence with the sponsor through project management team towards the matters related to Investigational products which includes quick response to sponsor queries, speedy update to the sponsor on IP related issues.
• Regular tracking of the archived investigational products enabling timely destruction of Investigational products after the completion of archival period.
• Hands on experience in facing sponsor audits and regulatory audits.

Clinical Research Coordinator

• Monitoring of various clinical trial activities like subject Check-In, Check-Out, Sample draw, Sample segregation.
• Coordinating with Investigators for reporting of SAE to Sponsor, Ethics Committee and Regulatory authorities.
• Review Case report forms for completeness and feasibility before the study start.
• To review and verify the Investigator Site File, Informed consent documents, CRFs, Source Data and other clinical data for legibility, completeness and accuracy.
• To ensure quality control process throughout the trial period.
• Proven potential to solve clinical trial related issues independently as well as in due coordination with Principal Investigator.
• Well demonstrated hands on experience in checking the clinical trial data leading to identifying potential errors, if any and getting rectified the same.

JOB RESPONSIBILITIES AT CLINIGENE INTERNATIONAL LIMITED

Pharmacist

• Receipt, Identification and Storage of Investigational Products.
• Dispensing of Investigational Products according to randomization schedule or as per protocol.
• Administration of Investigational Products to the study subjects.
• Archiving/Disposal/Return of Investigational Products.
• Accountability of Investigational Products at trial site.
• Maintenance of calibration/validation records of pharmacy equipments in co-ordination with the Maintenance department.
• General maintenance of pharmacy, to recording daily temperature and humidity of pharmacy equipments and pharmacy rooms. Daily cleaning of pharmacy.
• To prepare investigational product labels required for conduct of the study.

IEC CORRESPONDENCE

As per Investigator’s instructions responsible for developing study documents required to be submitted to Ethics Committee and obtaining approval for the same.

PROJECT CO-ORDINATION

• Preparation of CRFs for BA/BE Studies.

ADDITIONAL JOB RESPONSIBILITIES AS AND WHEN REQUIRED AND DELEGATED

QC CHECK

To review and verify the CRFs, Source Data and other clinical data for legibility, completeness and accuracy