To provide world class services to improve the quality of health care and reduce the efforts of our client in order to accelerate the overall process of drug development.
FDA 2013 Clinical Investigator Training Course: The Investigator as Collabora...MedicReS
FDA 2013 Clinical Investigator Training Course: The Investigator as Collaborator in Promoting the Clinical Research Enterprise
Neil J. Weissman, M.D., MedStar Health Research Institute
To provide world class services to improve the quality of health care and reduce the efforts of our client in order to accelerate the overall process of drug development.
FDA 2013 Clinical Investigator Training Course: The Investigator as Collabora...MedicReS
FDA 2013 Clinical Investigator Training Course: The Investigator as Collaborator in Promoting the Clinical Research Enterprise
Neil J. Weissman, M.D., MedStar Health Research Institute
Learning through mistakes is the best way to study. At the sametime, it improves the professional growth and also helps to minimize the gap between theory and the practice.
Role responsibilities of_a_clinical_research_coordsushant deshmukh
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial
1) Before starting the clinical trial:
A guide to become clinical research associatepptxRidhimaPatel2
An integral part of modules in clinical research courses focus on the ethical standards that have to be implemented without compromising the quality of trial results.
Clinical Research|Clinical Research Organisation|Clinical Development of drugskeerthipriya197
Abiogenesis Clinpharm Private Limited is a Clinical Research Organization(CRO) having experience and expertise in Clinical development of drugs, Bio-similar, Vaccine and Devices from preclinical to Phase IV clinical trials involving different study populations and many therapeutic areas for Nutraceutical and Pharmaceutical Companies & Pharmacovigiance Companies in Hyderabad and Clinical Research Companies in Hyderabad. Our expertise team will ensure efficient project management in managing Clinical trial services in different areas like Cancer Clinical Research Services, Oncology Clinical trial, Pharmaceutical data management, Clinical Study data management, Vaccienceutical clinical Trials, Pre-clinical drug development, Bio-similar Clinical Trials, Cancer Clinical Research Services. We offered end-to-end service for organisation whether it may be single project or designing a full-service. We are ready to assist you in clinical trial management for Clinical trials in oncology new drug development.
Learning through mistakes is the best way to study. At the sametime, it improves the professional growth and also helps to minimize the gap between theory and the practice.
Role responsibilities of_a_clinical_research_coordsushant deshmukh
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial
1) Before starting the clinical trial:
A guide to become clinical research associatepptxRidhimaPatel2
An integral part of modules in clinical research courses focus on the ethical standards that have to be implemented without compromising the quality of trial results.
Clinical Research|Clinical Research Organisation|Clinical Development of drugskeerthipriya197
Abiogenesis Clinpharm Private Limited is a Clinical Research Organization(CRO) having experience and expertise in Clinical development of drugs, Bio-similar, Vaccine and Devices from preclinical to Phase IV clinical trials involving different study populations and many therapeutic areas for Nutraceutical and Pharmaceutical Companies & Pharmacovigiance Companies in Hyderabad and Clinical Research Companies in Hyderabad. Our expertise team will ensure efficient project management in managing Clinical trial services in different areas like Cancer Clinical Research Services, Oncology Clinical trial, Pharmaceutical data management, Clinical Study data management, Vaccienceutical clinical Trials, Pre-clinical drug development, Bio-similar Clinical Trials, Cancer Clinical Research Services. We offered end-to-end service for organisation whether it may be single project or designing a full-service. We are ready to assist you in clinical trial management for Clinical trials in oncology new drug development.
I have recently relocated to the Denver, Colorado area and I am actively seeking a position, in research, that can challenge and utilize the professional knowledge I have acquired over the past four years. I am a self motivated, ambitious young professional who has worked very hard to become an effective asset and team member to each organization which I have been a part of. Since my graduation with a BS Clinical Research, I have worked in a variety of positions including corporate CRO research (INC Research), direct clinical care (Nursing Assistant at UNC and Duke Hospitals), and most recently, Clinical Research on the site level with the Duke University Cardiothoracic Surgery Research Team. My previous team lead and research practice manager, included as references on my resume, will likely cite my ability and willingness to learn quickly, interact with subjects/patients in a personable manner, and develop productive working relationships with my team members. I pride myself on my work ethic and enjoy working around others that inspire that same dedication.
I have recently relocated to the Denver, Colorado area and I am actively seeking a position, in research, that can challenge and utilize the professional knowledge I have acquired over the past four years. I am a self motivated, ambitious young professional who has worked very hard to become an effective asset and team member to each organization which I have been a part of. Since my graduation with a BS Clinical Research, I have worked in a variety of positions including corporate CRO research (INC Research), direct clinical care (Nursing Assistant at UNC and Duke Hospitals), and most recently, Clinical Research on the site level with the Duke University Cardiothoracic Surgery Research Team. My previous team lead and research practice manager, included as references on my resume, will likely cite my ability and willingness to learn quickly, interact with subjects/patients in a personable manner, and develop productive working relationships with my team members. I pride myself on my work ethic and enjoy working around others that inspire that same dedication.
1. CURRICULUM VITAE Page 1 of 3
Name Academic Qualification(s)
Mr. Mutyala V A Ramakrishna B.Pharmacy, PG Diploma in Clinical
Research
Address:
(Name of Institution, Street, City, Postal Code, State or Province (if applicable), Country)
Site Lead-Clinical Operations,
Research Room,Department of Medicine,
King George Hospital, Visakhapatnam-530002,
Andhra Pradesh, India.
Telephone Number FAX Number
(Country Code, Area Code, Number)
+91-9492254998
(Country Code, Area Code, Number)
Education and Training :
Course
/Examination
Institution/University/Board Year of
Passing
Performance Area of Study
PG Diploma in
clinical research
Avigna Clinical Research institute,
Bangalore
2012 First class Clinical research
B.Pharmacy JNTU Anantapur 2011 Second class Pharmaceutical
Sciences
Intermediate State Board of Technical Education
& Training, A.P.
2006 First class Biology, Physics
& Chemistry
SSC Board of Secondary Education,A.P. 2004 First class Science, social
studies &
Mathematics
Professional Experience:
Position/Title
Name and Location of Institution
Dates
(Start/Stop Dates as
applicable)
Current
Site Lead-Clinical Operations
King George Hospital,
Visakhapatnam-530002,
Andhra Pradesh, India.
06-Jan-2015 to Till date
Sr.Clinical Research coordinator
King George Hospital,
Visakhapatnam-530002,
Andhra Pradesh, India.
09-Jun-2014 to 05-Jan-2015
Clinical Research coordinator
King George Hospital,
Visakhapatnam-530002,
Andhra Pradesh, India.
02-Dec-2013 to 08-Jun-2014
2. CURRICULUM VITAE Page 2 of 3
Previous participation in clinical trials
Indication of Trial Clinical Phase of
Trial (I-IV)
Role in Trial (e.g.
Investigator, Sub-
Investigator)
Year in which
trial was
conducted
Type-2 Diabetes Mellitus III Study Coordinator 2015 on going
Rheumatoid Arthritis III Study Coordinator 2014
Osteoarthritis III Study Co-ordinator 2014
Hypertension III Study Coordinator 2014
Bioequivalence of Azathioprine II Study Coordinator 2014
Diabetes III Study Co-ordinator 2014
ACS III Study Co-ordinator 2014
Over Weight III Study Co-ordinator 2013
Nutrition III Study Co-ordinator 2013
Major Depressive Disorder III Study Co-ordinator 2013
Responsibilities are summarized below
Functional Expertise
• Familiar with Query Management for both paper and EDC studies, DATA Reconciliation, Discrepancy
Management.
• ICH GCP guidelines including quality assurance and role of pharmacist in clinical trial.
• Roles and responsibilities of Sponsor, CRA/Monitor, Investigator, IRB, and QA.
• Investigational product accountability.
• Informed consent and case report form.
√ Work according to SOP’s & GCP √ Filling Up Case Report Form
(Electronic CRF & Paper
CRF)/ Clearing DCFs
√ Conduct of feasibility studies
√ Complained with respective study
protocols
√ Maintenance the study file and
source documents of the
patients
√ Study preparation activities
management
√ Coordinating with Investigator √ Coordination With Central Lab
and Study Team
√ Interacting with the Ethics
Committee
√ Scheduling patient visits and
Follow-Up for the trial
√ Maintaining all Study related
trackers
√ Maintaining personal training
records
√ Managing patient visit related
activities
√ Shipping of sample √ Maintaining investigator data
base
√ Reporting of Serious Adverse
Events
√ IVRS & IWRS interaction √ Training of trainee CRC
3. CURRICULUM VITAE Page 3 of 3
• Reported Serious Adverse Events and knowledge of drugs, it’s mechanism of action and its interactions.
Training on ICH/GCP: YES If yes, specify below NO
• On site ICH GCP training was taken on 04th
Dec 2013 during SIV.
• Attended ICH-GCP Training & workshop conducted by Sanofi Aventis held at KGH, Visakhaptnam
on 30th
Dec 2013.
• On site ICH GCP training was taken on 04th
Jun 2014 during SIV.
• On site ICH GCP training was taken on 26th
Dec 2014 during SIV.
Other documents evidencing experience or expertise attached: YES If yes, specify below NO
• Participated in e-crf training in 2013 given by Zydus Cadila.
• Participated in e-crf training in 2015 given by Clinsync.
• Participated in e-crf training in 2016 given by Zydus Cadila.
• Faced an External Audit for the study “Bioequivalence of Azathioprine” on 12th
Nov 2015 by
Manager-Quality Assurance, Clinsync., Hyderabad
• Faced an FDA Audit for the study “OSTEOARTHRITIS” on14th
to 18th
-Dec-2015 by U.S,FDA
Investigator Janete F .Guardia of U.S Embassy FDA-India ,New Delhi.
• Faced an FDA Audit for the study “Bioequivalence of Azathioprine” on19th
to 23rd
-Sep2016 by
U.S,FDA Investigator Janete F .Guardia of U.S Embassy FDA-India ,New Delhi.
• Faced an DCGI Audit for the study “Bioequivalence of Azathioprine” on19th
to 23rd
-Sep2016 by
CDSCO Investigator Mr.Chandra Shekar of Government of India, Hyderabad.
Signature Date
04-Sep-2016
Printed Name: Mutyala V A Ramakrishna E-mail Id : ramakrishnacrc@gmail.com
