PG Diploma in Clinical Research, Clinical Research Coordinator

A Clinical Research Center Offers Training in Clinical Research, Clinical Trial Management, Clinical Data Management, Pharmacovigilance, Medical Writing and Bio informatics.

FAQs Relating to Training Courses in Clinical Research, Healthcare, Medical Writing, Clinical Data Management and Pharmacovigilance.

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FAQ's

1. What are the job prospects after doing PG Diploma in Clinical Research from your Institute?

There is huge demand for trained & qualified Clinical Research professionals in the Industry. Jobs are available in Contract Research Organizations, Pharmaceutical Companies and Research Sites. Salaries are according to qualification & experience ranging from Rs. 2, 00,000 to Rs. 18, 00,000 annually.

Our programs are totally job oriented and the course curriculum is developed as per the industry requirements with Specializations in Clinical Research, Data Management, Pharmacovigilance and Pharma Regulatory Affairs. Your future employers are our faculty members. We provide 100% placement assurance by campus interviews. We are also having in -house placement opportunities. During On Job Training (OJT /internship), students will be placed directly to the investigator site and in the industry, this will definitely give them a very good opportunity to prove their skills.

2. Is your institution recognized by AICTE/UGC or any state govt.?

Yes it is recognized by University of Mysore

3. Does your institute provide any placement assistance or guarantee?

Yes, we provide 100% placement assurance to the students doing their Full time and Part time classroom programmes, and placement assistance will be given to Distance Learning.

4. What is the scope of Clinical Research in Karnataka?

Karnataka is very large state of India and has a diverse pool of patients and very good infrastructure. In last 2 years the clinical research activities in Karnataka increased by 5 folds and at present about 80 clinical trials are ongoing in Karnataka. Many CRO's and Sponsors are looking here to establish their centers here.

5. Do you provide hostel facilities?

Yes, we do have separate boys and ladies hostels

6. Where the students will be placed for internship and project work?

During internship students will be placed directly in the CRO industry and at the investigator sites so they can have a practical approach/exposure to Clinical Research Methodologies and Processes.

7. What is the job profile of clinical Research Coordinator?

Job profile of CRC includes

	Management of research study site
	Recruiting, screening and enrolling clinical study participants
	Informed Consent Process
	Arranging follow-up visits
	Maintaining and dispensing drug and other study supplies
	Completing and ensuring the accuracy of case report forms and regulatory documents
	Ensuring the adherence to good Clinical Practice guidelines
	New study site feasibility

8. What is the job profile of clinical Research Associate / Monitor?

Responsible for monitoring the progress of clinical trials & ensuring that it is conducted according to approved protocol, standard operating procedures, GCP & the applicable regulatory requirements from starting to end of the study.

Locating and assessing the suitability of facilities at a study centre.

Briefing doctors/consultants (or investigators) on conducting the trial.

Managing regulatory authority applications and approvals.

Monitoring the trial throughout its duration, this will involve visiting the study centers on a regular basis.

Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as Source Data/document Verification (SDV)..

Collecting completed CRFs from Research sites.

Filing and collating trial documentation and reports.

Ensuring all unused trial supplies are accounted for.

Close out of the study centers on completion of the trial.

Discussing results with a medical statistician & other authorities.

Archiving study documentation and correspondence.

Preparing final reports.

9. What is the different job profiles in the of Clinical Research Industry?

The Clinical Research industry is an integrated industry where in there are a lot of job profiles available, for example;

Clinical Research Associate

Clinical Research Coordinator

Clinical Trial Assistant/Research Scientist

Clinical Research Investigator

Study Coordinator

Associate Study Coordinator

Data Manager / Biostatistician

Regulatory Affairs Manager

Clinical Trials Auditor

Clinical Project Manager

Clinical Research Manager

Clinical Data Coordinator

Clinical Data Associate

Data Entry Operator

Clinical Data Validator

Clinical Data Reviewer

SAS programmer

Biostatician

Business Development Manager

Clinical Development Manager

Drug Safety Associate

Safety scientist

Product safety monitor

Regulatory Affairs Associate

Scientific Medical Writer

Medical Writer

QA Associate

QC Associate

10. What are the eligibility criteria for admission?

Minimum eligibility criteria for application to the course would be either of the following:

	MBBS/ BDS / BHMS / BAMS / BPT / BUMS / Bachelor in Naturopathy & Veterinary Science.
	A graduate / postgraduate in Pharmacy or Pharmaceutical Sciences.
	Graduate / Postgraduate in Life sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
	BE/B.Tech in Biotechnology, Medical Engineering.
	A graduate or equivalent degree in Nursing.

11. What will be the admission procedure?

	A preliminary review of applicants will be made on the basis of submitted application.
	An Interview Committee will then invite those applicants who are deemed suitable to a personal interview at IC Bio Clinical Research.Pvt.Ltd, Bangalore (All transportation and supplementary costs of attending the interview are the responsibility of the applicant.)
	he results of the interviews will be forwarded to the Program’s Selection Committee of the Board of Directors for their consideration. All applicants will be notified of the Board's decision
	Once selected a selection letter will be sent to you and you could register at our office address with the prescribed registration fees in person/post within 10 days.
	On registration all study materials in the form of books and CDs will be provided and you could start attending classes.

12. How can I get application form for PG Diploma Clinical Research?

You can just download application form from our website.

FAQs FOR PEOPLE INTERESTED IN CLINICAL DATA MANAGEMENT

What is Clinical Data Management?

Collection, integration and validation of clinical trial data.

What kind of data will I be managing?

All clinical trial data including safety and efficacy data of drugs/agents under study.

What kind of data does CDM have?

All data coming from CRF from sites (hospitals/clinics) and non-CRF data coming from clinical laboratories.

What exactly will I be doing in CDM?

Collect and validate the trial data, review and querying the investigators, and quality assurance of the trial data, etc.

What will be my daily routine in this Job?

You will be working on computer applications like Oracle - Clinical, Clin-Trial etc, creating database, CRF designing, validations, reviews, interacting with Investigators, etc.

Does this job involve traveling?

Not necessarily since it is more of a in-house job.

My Dad says this CDM industry is a new field, is it true? If so what is the future in it for me?. Is it not risky to take it as a career?

It certainly is a new field and that’s why one gets more advantage if you opt for a CDM course as it adds value to one's career and is in much demand in today’s market. Drug Research can never stop and so there is no risk as this is an ever growing industry.

My husband is a software engineer, he travels abroad very often can I work abroad as a CDM professional?

Yes

I am not comfortable with computers is it ok/ can I pick up the computer skills needed for CDM?

Basic knowledge of computers is essential because it is IT enabled service. No specialized computer skills are required

All I can do with computers is only check mails, browse the Internet, chat, and type some letters- do I have to do any special computer courses?

No, not required, just the basics are sufficient. Using the data management systems will be taught in the course. No programming knowledge required.

I have worked as a Medical transcriptionist and Proofreader, is CDM related to this kind of Job?

No, CDM is not related to Medical transcriptionist. It will be easier since you are familiar with medical terminology.

Does this job require lot of time to pick up skills?

No, because we are providing training for the same and the course is well structured.

Should I have to carry my job to home like most of the software professionals?

Since this job involves confidentiality, it cannot be carried home.

Is it necessary to working in shifts?

This cannot be ruled out, it may happen depending on the company.

I have heard there is lot of stress in this Job, is it true?

It is not stressful; as a matter of fact stress is there in every modern day profession.

I have heard people in this industry need Hands-on-experience, could you please explain this?

Yes it’s true, that’s why we will provide hands - on experience and the 2nd semester would have practical sessions. Regular assessment would be done to monitor the students.

As a Master degree holder I am always interested in research, does CDM give me exposure to research field?

Yes

Where will I be employed after doing CDM course?

You will be absorbed as Clinical Data Associate or Clinical Data Coordinator in Pharma / Biotech companies or Contract Research Organizations or IT companies providing CDM services.

How much will be the initial or start up salary for CDM professional?

Somewhere around Rs.2 lakh per annum.

Is CDM an Out-sourced Job?

Clinical Research Organization (CRO) itself is an outsourced job, especially the service industry. This is currently a happening industry in our country.

I have heard many software companies are into CDM, is it true? Does this mean I will have a larger scope for employment?

Yes. The IT companies have already entered into CDM arena and therefore would be a huge opportunity for career growth.

How many trained CDM professionals are there in India today?

Few hundreds, which is just not enough for the current scenario.

I am a Veterinary professional, What are the chances of getting involved into Clinical Trials?

You will be involved in Clinical Research related activities; you can also focus on Clinical Data Management.

I have worked in Insurance claims processing-BPO industry, is CDM in any way related to this process?

Insurance is totally different and not related to CDM.

I have heard CDM requires Eye-for-detail, could you please explain this terminology?

Accuracy and quality is essential in any business.

I have learnt some foreign language French / German / Spanish / Mandarin. Will this be helpful?

From the course point of view, it may not be essential but it adds value if you want to have a global exposure.

Is this course beneficial for Nurses?

Yes

How am I qualified for CDM as a pharmacy graduate/Postgraduate?

Pharmacovigilance also follows a lot of the CDM processes and you familiar with Pharmacology related subjects. This understanding is required for safety reporting’s.

I have 5 years of experience as a medical representative; will this experience help me in CDM job?

It would be a value-add to your career prospects, though CDM is not for you unless you want to shift your career as you have an adequate knowledge with regard to Pharma.

I have assisted many Senior Doctors in Clinical trials, is CDM related to this?

Yes. It's a continuation of Clinical Research activity.

Are all graduates eligible?

All graduates related to life sciences, math’s, statistics, and computer science are eligible.

How best am I suited for a job in CDM as a Statistician?

That's one of the good backgrounds to have.

I am a fresh Masters in Bio-Statistics; What will be my role in CDM industry?

You can be part of the CDM team and specialize in statistical analysis and reporting.

Why Life Science graduates/Postgraduates are preferred for CDM industry?

Because of the domain experience and the terminologies associated with it.

I am aware of fresh graduates who are empSloyed in CDM industry without this course. Why should I do this course? What will be the salary difference of the person who has not done this course?

There's definitely a difference. You will have an edge over them and your chances of getting jobs are easier and, growth is faster. Salary difference could be significant.

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