Careers & Courses

I wish to pursue a challenging career in Clinical Research Operations with enormous capabilities to contribute my knowledge and skills in a position with fast steady growing and dynamic firm. Comply with GCP guidelines and SOPs for the conduct of clinical trials.

  • Sincere and diligent professional with an overall cross–functional experience of over 5 years across Clinical Research, Pharmacological Research, Neutraceutical Research and Quality Control.
  • Proficient in swiftly ramping up research projects with cross–functional skills & ensuring deliverables within stipulated time frame. Expertise in project planning, scheduling & resource planning to achieve specific research targets
  • Thorough academic exposure and dexterity across regulatory guidelines and submission procedures in regulated markets; adept at preparation of protocol, CRF and clinical reports.
  • An effective team leader with exceptional planning and execution skills coupled with a systematic approach and quick adaptability. Solid ability to translate technical information and provide training to staff and patients.

Responsibilities:

  • Conduction of Medical Study Examination (Monitoring Vitals, Physical Examination, Systemic Examination)
  • Review of ECG for volunteer during screening.
  • Review of the lab reports and recording details in relevant documents.
  • Assisting in Hospitalization of Study subject.
  • Recording of adverse events and management of it with the intimation of principle investigator and Filling of details of adverse event form.
  • Keep a close association with site for: Patient Recruitment, Patient Follow Up, protocol related activities
  • Help in preparation of Regulatory Binder Ensuring that conduct, recording and reporting of clinical trials is as per ICH-GCP guidelines, ethical considerations and SOP’s.
  • Review of Clinical Trial Protocol and preparation of protocol amendments.
  • Review of CRF and Patient Information Sheet and Consent Form
  • Design & Review of Media (Newspaper) Advertisement for clinical studies as per ethical considerations.
  • Review of Investigational Products and other clinical trial materials (CRF’s, patient information sheets and their translated versions, Pharmacokinetic kits, schedules for activities during the conduct of trial).
  • Maintaining and completion of essential documents for EC submissions.
  • Ensuring prompt recording and reporting SAE (Serious Adverse Events) to regulatory authorities.
  • Interaction with Central Laboratory, IEC, CRO, CRA for ensuring GCP compliance.
  • Updating the investigator processing and shipment of Pharmacokinetic and clinical Laboratory Samples as per GLP.
  • Design & Review of Media (Newspaper) Advertisement for clinical studies as per ethical considerations.
  • Updating the investigator site logs.
  • Query resolution generated by monitors and auditors.

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