Career Options for Pharm.D in Clinical Research : An Indian perspective

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Background:

Doctor of Pharmacy is a highly professional doctoral degree adopted from the West by the Pharmacy Council of India (PCI) and Government of India in 2008, but the council failed in adopting the quality practise from the West, which is the prime problem degrading the profession. Apart from Community Pharmacy, Hospital Pharmacy and Clinical Pharmacy, now we are left with some contemporary options like Clinical research, Pharmacovigilance, Clinical Trial Management, Medical writing, Regulatory Affairs.

Today I would like to discuss about various positions in Clinical Research; the other career options will be discussed further *Any graduate in pharmacy are eligible to apply for these positions.

Clinical Research:

Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological or adverse effects with the objective of determining safety and efficacy of the new drug. The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials ethically as per Declaration of Helsinki and International Conference on Harmonization Guidelines (ICH) using good clinical practice (GCP) under the auspices of the Principal Investigator (PI). Outweighs patients risks and benefits, rights, safety and well being.

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

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Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia