Clinical Trial Management

A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug.

Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research and Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.

Work Profile:

  • Clinical Research Coordinator (CRC)
  • Clinical Research Associate

Clinical Research Coordinator (CRC)

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

 

  • All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
  • Benefits outweigh risks for each patient.
  • Rights, safety and well-being of patients prevail over science.
  • All available non-clinical and clinical information on any investigational agent can support the trial as designed.
  • All trials are scientifically sound and clearly described.
  • All clinical trials have current Institutional Review Board approval.
  • Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
  • Everyone involved in the clinical trial is qualified by training, education and experience.
  • Informed consent is given freely by every participant.
  • All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
  • Confidentiality of subjects is respected and protected.
  • Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
  • Systems to ensure quality are implemented in all aspects of the trial.

Clinical Research Associate

CRA Is key participant in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic reports, New Drug Applications (NDAs) etc. Participates in design and writing of protocols, case report forms and informed consent forms for clinical trials. Productive in recruitment/selection of new investigators, contract research organizations and outside vendors. Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary.
Ensures that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group. Involved in the compilation/writing of integrated medical reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) etc. Assists in preparation of presentations and manuscripts of scientific meetings and technical journals. Attends scientific/professional meetings and training courses as appropriate.

1 CR

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