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Clinical Trial Management

A Clinical Research is a systematic study of new medicines in human subjects that generates data for the discovery or verification of clinical, pharmacological (including pharmacodynamics and pharmacokinetics) or adverse effects with a view to determining the safety and efficacy of the new drug.

A Clinical Research is a systematic study of new medicines in human subjects that generates data for the discovery or verification of clinical, pharmacological (including pharmacodynamics and pharmacokinetics) or adverse effects with a view to determining The Clinical Research Industry is growing at an unprecedented rate around the world over the last few years. It has opened up new possibilities of job for a large amount of people.

The Clinical Trials industry is worth more than US$ 45 billion globally and the company has employed an estimated 2.10,000 people in the US and more than 70,000 people in the UK, making up one-third of the total research and development workforce. Such large numbers can be attributed to the fact that this industry provides lucrative employment opportunities. The overall cumulative annual salary rise for all jobs is 4 per cent compared to less than 1 per cent for other categories.the safety and efficacy of the new drug.

 

Work Profile:

  • Clinical Research Coordinator (CRC)
  • Clinical Research Associate

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC) is accountable for conducting clinical studies using good clinical practice (GCP) under auspices of the Principal Investigator (PI).

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  • All experiments shall be conducted ethically, as specified in the Helsinki Declaration, rigorously, as defined in the International Conference on Harmonization Guidelines (ICH).
  • Benefits outweigh the risks for every patient.
  • Patients ‘ interests, health and well-being prevail over research
  • Any available non-clinical and research information on any investigational agent can help the research as planned
  • All of the trials are scientifically sound and clearly described.
  • All clinical studies have the official approval of the Institutional Review Board. 
  • Medical decisions and treatment are the responsibility of trained health professionals, in particular doctors and, where applicable, dentists.
  • Each person involved in the clinical trial is eligible by training, education and experience.
  • The informed consent of each party shall be given freely.
  • All research documentation is collected, processed and preserved to enable accurate reporting, analysis and verification.
  • The confidentiality of subjects shall be valued and secured.
  • Good Manufacturing Practice in Processing, Manufacturing and Handling shall be preserved by research goods.
  • Quality assurance processes are put in place in all facets of the trial.

Clinical Research Associate

CRA is a key participant in the creation, execution and tracking of clinical trials, preparation of integrated medical reports, INDs, Investigation Device Exemption (IDE), periodic reports, New Drug Applications (NDAs), etc. Participates in the design and drafting of guidelines, case studies and informed consent forms for clinical trials. Productive in the hiring / selection of new investigators, contract research institutions and outside suppliers. Accountable for the planning and execution of all procedures required to behavior and track complex clinical trials and to ensure that Good Clinical Practice (GCP) are followed. Conducts pre-study site visits, at the start of the research, at regular intervals during the project and in close proximity to the study. Monitors the performance of researchers and adherence to the procedure, and proactively address issues of conduct and problems of enrollment as necessary.

Ensures that the Case Report Forms (CRF) are checked in a timely manner and sent to the Data Management Committee. Contributed to the compilation / writing of comprehensive medical reports and clinical portions of INDs, IDEs, New Drug Applications (NDAs), etc. Assisting in the preparation of reports and documents of scientific meetings and academic papers. Participates in scientific / professional meetings and training courses as an interface