The M.Sc Clinical Research is the most happening field in today’s world. The changed lifestyle of the people has given rise to new diseases among humans. The pharmaceutical companies are forced to develop new drugs and treatments to treat these diseases.
The pharmaceutical companies conduct extensive field trials for the drugs that are developed by them. The M.Sc Clinical Research students are skilled professionals and are required in large numbers by many of these pharmaceutical companies.
These pharmaceutical companies offer different job roles for the skilled M.Sc Clinical Research students, but the present article discusses some of the crucial and important job roles available for the M.Sc Clinical Research students. The article discusses the important roles available for skilled professionals that offer good salary packages and better career opportunities.
Let’s discuss them in detail below:
Regulatory Affairs officer
As a regulatory Affairs officer one should ensure to have the preoperative licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy.
Role of a Regulatory Affairs Officer
As a regulatory Affairs Officer one will act as a crucial link between the company and regulatory authorities. As a Regulatory Affairs officer one is required to combine his/her scientific knowledge of scientific, legal and business issues and ensure that the products developed, manufactured or distributed by a range of companies meet the required legislations.
Responsibilities of a Regulatory Affairs Officer
As a Regulatory Affairs Officer one is needed to:
- Ensure that a company’s products comply with the regulations of the regions where they want to distribute them
- Keep up to date with national and international legislation guidelines and customer practices
- Collect, collate and evaluate scientific data from a range of sources
- Develop and write clear arguments and explanations for new product licences and licence renewals
- Prepare submissions of licence variations and renewals to strict deadline
- Monitor and set timelines for licence variations and renewal approvals
- Work with specialised computer software and resources
- Write clear, accessible product labels and patient information leaflets
- Plan and develop product trails and interpret the trial data
- Advice fellow scientists and manufactures on regulatory requirements
- Provide strategic advice to senior management throughout the development of new product
- Review company practices and provide advice on changes to systems
Earning Potential
- Fresh M.Sc Clinical Research students will earn about 5 lakhs to 7 lakhs per annum as a Regulatory Affairs Officer
- Experienced professionals will be earning around 8 lakhs 10 lakhs per annum
Clinical research Associate
The Clinical Research Associates are required to monitor the drug trials of the newly developed drugs and should be capable to provide all the facilities that are required for conducting clinical trials.
Role of a Clinical Research Associate
As a clinical research associate, one is required to run clinical trials to test drugs for their effectiveness, risks and benefits. They are also responsible to ensure that they are safe and ready for mass production and are allowed to market. As a Clinical research associate, one is required to work on new and existing drugs and will usually work in pharmaceutical companies.
Responsibilities of a Clinical Research Associate
As a Clinical research associate, one is needed to:
- Develop and write trial protocols for clinical trials
- Present trial protocols to a steering committee
- Design data collection forms, known as case report forms
- Coordinate with the ethics committee which safeguards the rights, safety and well-being of all trial subjects
- Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
- Identify and assess the suitability of facilities to use as the clinical trial site
- Coordinate with doctors, consultants or investigators on conducting the trials in a trial site
- Setup trial sites and ensure that all the trial materials are available
- Prepare the reports about the trials conducted and send it to the authorities
Earning Potential
- Fresh M.Sc Clinical Research students will earn about 4 lakhs to 6 lakhs per annum as a Clinical Research Associate
- Experienced professionals will be earning around 6 lakhs 8 lakhs per annum
Drug Research Associate
The Drug Research Associates are the professionals who are expected to engage themselves in different field trials for testing drugs. They are responsible to identify the specific location and ensure that all the infrastructure is available for conducting drug trials for a newly developed drug for a specific condition.
Role of a Drug Research Associate
The Drug Research Associates are responsible to run clinical trials to test drugs. The Drug Research Associates use the trial data to evaluate effectiveness, risks and benefits of the drugs on the trial subjects. The Drug Research Associate is expected to work on both new and existing drugs. They usually work in tandem with the research and development team of pharmaceutical companies and the management.
Responsibilities of a Drug Research Associate
As a Drug Research Associate, one is responsible to:
- Plan and implement the drug trial protocols for newly developed drugs
- Give detailed explanation of the trail protocols to the steering committee and get approvals
- Create and develop data collection forms for gathering results from clinical drug trials
- Coordinate with the ethics committee and ensure that subjects exposed to drug trials are safe and healthy
- Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
- Identify and assess the suitability of facilities to use as the clinical trial location
- Coordinate with doctors, consultants or investigators on conducting the trials and trial location
- Setup trial sites and ensure that all the trial materials are available
- Prepare the reports about the trials and explain the intricacies of trails to the authorities
Salary and Emoluments
- The fresh M.Sc Clinical Research students will be earning around 6 to 8 lakhs per annum as a Drug Research Associate
- The salary for experienced professionals will be around 10 lakhs to 12 lakhs per annum.
Clinical Scientist
The Clinical Scientists usually work in clinical research labs. They are responsible to analyse samples taken from patient’s blood, urine and other bodily fluids. They use them to diagnose, manage and provide treatment for the diseases. They use different clinical agents to identify the cause of the infection or anomaly
Role of a Clinical Scientist
The Clinical Scientists usually work in clinical research labs in pharmaceutical companies. They are responsible to interpret the results of the samples obtained from patients on the advice of clinicians and doctors. They are required to conduct necessary tests and investigate the cause and effects on the human body.
Responsibilities of a Clinical Scientist
As a clinical scientist one is needed to:
- Plan and organise work in clinical research labs for collection of samples
- Carry out analysis on specimens of body fluids and tissues
- Perform clinical validations by checking for abnormal results
- Audit the use and diagnostic performance of tests
- Identify and resolve any poor analytical performance problems
- Develop new and existing tests which can involve significant manual expertise
- Coordinate with clinical and health care staff and have some contact with patients
- Apply the clinical research skills to prevent disease and keep patients healthy
Salary & Emoluments
- An average fresh M.Sc Clinical Research student will earn about 4 to 5 lakhs per annum as a clinical scientist
- The experienced professionals may earn about 5 to 7 lakhs per annum
Concluding Words
Clinical Research is gaining a lot of importance in the present scenario. In case of a pandemic situation like the Corona outbreak, the clinical research students are required in large numbers to conduct severe clinical trials for the vaccines and medicines that are developed by the pharmaceutical companies. Every pharmaceutical company today is developing vaccines and medicines that can stop the spread of the pandemic disease. But none of them have seen success till now. The clinical research students play a crucial role in these clinical trials.
The pharmaceutical companies are heavily investing in development of drugs and are looking for skilled professionals like M.Sc Clinical Research students. They are also offering good pay scales for the skilled professionals. The students who are interested in conducting clinical trials can join the M.Sc Clinical Research course.