www.neeman-medical.com Max Neeman International Pune Mumbai Hyderabad : Clinical Research Associate

[muthukalee]

neeman-medical.com

Position Title : Clinical Research Associate

Location : New Delhi / Mumbai / Pune / Hyderabad / Bangalore

Qualifications / who should apply :
Only MBBS candidates with 1 year of experience as Research Coordinator should apply

Job Description :
To successfully conduct the listed site visits as required by client/study -- Pre Study Site Selection, Site Initiation, Interim Monitoring, Site Close out.
Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff. If required train the study site team.
To confirm the appropriateness of the site for the study in all aspects and ensure that all documentation required to initiate the study is complete.
Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the Sponsor/CRO & NMI SOPs.
Monitor and track patient enrollment and study progress.
Perform site monitoring visits to include review of source document, case report form, ICD, Patient Diary, Investigator Site Binder, other documents as applicable.
Ensure the timely accurate and complete collection and submission of study data.
Identify, address, and resolve issues and problems as they might occur.

At Study Completion :
Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO.
Ensure that appropriate study documents are complete and properly filed.
Archival with Inventory list of Source documents/ CRFs/ CTM/ Others at site.
Prepare the site for possible Regulatory/ FDA inspection.
Prepare the site for possible Internal and/or Client Audits.
Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities.
To ensure 100% adherence to the monitoring and study plan.
Coordinate with Site, Vendors, Client, Regulatory & NMI to maintain best practices through out the course of the study.
This position requires 50-70% Travel.
To maintain confidentiality of clients/ projects & related information, as applicable.
To complete tasks assigned by management as deemed necessary.

Contact us:
Mumbai:
Max Neeman International
Ready Money Terrace
1st Floor, 167 Dr.A B Road
Worli Naka Mumbai-400 018, India

Hyderabad
Max Neeman International
6-3-563/A, Flat No. C 2, Somavarupu Heights,
Hill Top Colony, Erramanzil
Hyderabad-500004 A.P

Pune
Max Neeman International.
G-01, AJ Arcade
Near Gananjay soc,
Opp. Ashish Garden,
Kothrud,
Pune 411038

Bangalore:
Max Neeman International,
196/8, 8th F Main Road,
Jayanagar, 3rd Block,
Bangalore - 560011

Delhi
Max Neeman International
Max House, Ground Floor-1
Dr.Jha Marg, Okhla-III
New Delhi-110020

http://neeman-medical.com

http://neeman-medical.com/php/showCo...=193&partid=17

[Guest]

Respected Sir /madam

Myself Dr Deepali Patil have completed BAMS and done Clinical Research course and presently working as a clinical research co ordinator in Poona Hospital.

I want to apply for CRA in Maxx Neemans .

[Guest]

Hello sir,
I am Dr Naresh, BAMS graduate and I have a work experience as a CRC for one year.
I want to apply for the CRA post at Max Neemans.
MY CV
Curriculum Vitae
-Dr. Naresh Siddram Konapure (BAMS, PGDCR)
nkonapure AT gmail.com
Career objective-
To get challenging work, which would satisfy my instinct to learn and to do more and where, I would anticipate some quality work expertise that provides me an insight opportunity into the working environments of organization.
Work experience-
Organization- Pentagon Research Private Limited.
Designation- CRC & Regional Business Development Manager (RBDM).
Period- From 3rd August 2010 to till date.
No. Indication Phase No. Indication Phase
1. Metastatic NSCLC II 5. Pediatric Migraine III
2. Hypertension III 6. Ankylosing Spondylitis III
3. Ulcerative Colitis III 7. Acute Coronary Syndrome III
4. Atrial Fibrillation(ENGAGE) III 8. Atrial Fibrillation(PALLAS) III
Job Profile As RBDM :
Identification of Potential Investigators according to Need of Feasibility.
Confirmation of all the available facilities as per the need of the trial.
Negotiation of Budget with Investigator and Hospital Administration as per the Company Rules
& Regulations.
Job Profile As CRC-
a) Assisting Principal Investigators in the Informed Consent Process.
b) Assisting the Principal Investigators in screening and randomization procedures of patients .
c) Scheduling of Subjects Visits as per Protocol.
d) Completion and Maintaining Source Documents.
e) Coordination and Management of Local & Central Laboratory Samples, couriers and follow-ups of Lab Reports.
f) Drug Accountability and Dispensing.
g) Use of IVRS & IWRS.
h) Completion of Paper and eCRF with minimal error.
i) Resolving DCFs & eCRF Queries.
j) Preparation, Attendance and Follow-up of Monitoring visits.
k) Maintaining all Essential Documents in Site Master File.
l) Ethics Committee Correspondence for Submissions, Approvals and Notification.
m) Recording and Reporting of AEs and SAEs within proper timelines.
n) Coordination and Interacting with PI, Sub I, CRO, and other Study team members.
o) Trial Closeout & Site Initiation : Preparation & Attendance.
p) Overseeing the overall activities in accordance with the Protocol and the compliance of ICH-GCP & Indian regulations in conduct of trial.
Educational qualification-
Degree Year University Percentage
PGDCR 2009-10 ICRI, Mumbai. 74%
BAMS 2004-09 MUHS, Nasik. 64.40%
H.S.C. 2003 Pune board 76.50%
S.S.C. 2001 Pune board 77.86%
Computer Skills-
a. MS Office
b. INFORM 4.6 EDC Software.
c. RDC Oracle Onsite.
Training Undergone-
1. Attended “Refresher GCP Workshop” at Medipoint Hospital Pvt Ltd Conducted by Quintiles on 3rd May 2011.
2. Received GCP Training at SIV for Ankylosing Spondylitis & ACS & AF Studies.
3. Attended Investigators Meeting at Hyderabad for PALLAS Study on 30 Nov 2010.
Training Given-
1. Protocol training given to new coordinators on ACS & AF Studies.
Seminars Attended-
a. Continued Medical Education Programme arranged by Maharashtra Council of Indian Medicine, Mumbai conducted by National Integrated Medical Association, Maharashtra State at Solapur on 13 Feb 2010.
b. One day Seminar “Ayurvedamrut” organized by Ayurveda Vyaspeeth on Sunday 14 OCT 2007.
c. Good Manufacturing Practices Educational cum Study tour conducted by SGRA Collage, Solapur at SANDU’s Standards Certified Manufacturing Facilities on 9 DEC 06 at Pilerne, Goa.
d. National Seminar on Panchakarma sponsored by Department of AYUSH, organized by SGRA Collage, Solapur on 9th & 10th March 2006.
Strengths-
a. Detail oriented.
b. Efficient time management.
c. Good communication.
d. Adopting new things and environments faster.
e. Patience.
Achievements-
Got 2nd Rank in the class at ICRI, Mumbai for PGDCR.
Got Best coordinator award at Pentagon Research Pvt Ltd.

[Guest]

ARTI RAJKUMAR GUPTA
E-mail : gupta.arti2306 AT gmail.com
Profile :
- A Bachelor of Pharma professionally qualified with a Post Graduate Diploma in Regulatory Affairs.
- Keen learning ability to grasp new knowledge and apply the same in a resourceful manner.
- Meticulous attention to detail and ability to meet strict deadlines.
- Flexibility, Resourcefulness and Ability to work cohesively as a part of a Multidisciplinary team.
Objective :
To work with an organization that would give ample opportunities to prove my skills and my knowledge and in turn whatever I do, I ensure that I do it in the best possible, effective and an ethical manner.
Qualification :
Graduation / Certification / Others University/Institution Year of passing Record
Post Graduation (Msc.CRRA)
MSc in Clinical Research and Regulatory Affairs Sikkim Manipal University, Mumbai 2009
Post Graduate Diploma in Regulatory Affairs
(PGDRA) Global Institute of Regulatory Affairs, Pune Aug 2009 – Feb 2010
Graduation : B-Pharm
Bachelor of Pharmacy Modern College of Pharmacy, Pune (Pune University)
2005-2009
First Class with Distinction
HSC Nowrosjee Wadia College, Pune (Pune University) 2004-2005 First Class with Distinction
SSC St. Ursula High School, Pune 2002-2003 First Class with Distinction
Skills :
- Written and oral communication abilities.
- Computer skills : Proficient with Microsoft Office.
- Detailed knowledge of ICH guidelines including basic understanding of regulatory requirement.
- Ability to prepare CTD-Dossiers, DMF.
Work experience :
Designation Company /Hospital Experience Duration
Internship
Sahyadri Speciality Hospital 3 months
Sahyadri Clinical Research and Development Centre (SCRDC) - Informed Consent Process
- Investigational product dispensing and accountability
- Data Entry Procedure
- ICH-GCP Guidelines
- Quality aspects
Junior Regulatory Affair Executive 12 months
Perfect Pharmaceutical Consultants Pvt. Ltd - Validation
- Preparation of Common Technical Document (CTD), Drug master File (DMF)
- Regulatory submissions guidelines
- Management skills
Achievements :
- Written a book on Clinical Research named,” A Dummy’s Checklist for Clinical Trial”.

- Best Outgoing student in College while pursuing Graduation.
- Attended 10 months Clinical Research Educational Programme (CREP) conducted by Alumini students during B-Pharm.
- Winner for the Project “Clinical Data Management” and Seminar on Case Report Form in CREP.
- Winner for Pharma Poster competition.
- Successfully completed a course of Acupressure in Global Medical Foundation in 2008.
- Successfully completed a practical project on “Mouth Melting Tablets” during Graduation.
- Completed 1 month industrial training in Twilight Litaka Pharmaceuticals Pvt. Ltd.
- Participated in National Service Scheme during Graduation.
- Successfully participated in United Nation exams and geographical talent search in school.

[Guest]

hello sir /mam . myself dr anita jaguri . a bhms fresher doctor. want to work with max neeman . my email id is anitajaguri99 AT gmail.com . i am putting in noida.
thanks .

[Guest]

Dear Sir/Madam,
I am Dr. Rohinee Bhandare & looking forward to work with your renowned company.
CURRICULAM VITAE
Mrs. Dr. Rohinee A. Bhandare
Email id : docchothe AT gmail.com
Career Aim : Seeking a challenging position, utilizing my abilities developed through my experience and education with an opportunity to enrich and enhance in the field of research through knowledge, skills and continuous dedication.
To make contribution towards organizations growth.
To establish empathetic relationship with the organization and peers .
Education :
- A.D.C.R.- Clinovision - Institute For Clinical Research/SMO (2010-2011)
- B.A.M.S. (first class) - Dr. D. Y. Patil College of Ayurveda & Research Centre, Pimpri, Pune (2004-2010)
- HSC (first class) - Modern College of Arts, Commerce & Science, Pune (2003)
Project :
Preparation of Dummy Protocol for the title -
Randomized open lable, placebo control, open lable trial for the evaluation of Efficacy & Safety of two Bronchodilators (Placebo & Salbutamol) for the treatment of Bronchial Asthma.
Presentation :
CRA Responsibilities .
Work Experience :
Intern Dr. D. Y. Patil Ayurved Hospital, Pimpri. Pune-6 Months
Rural Hospital Manchar, Tal-Khed, Dist.-Pune-3 Months
Primary Health Center Wadebolhai, Pune-3 Months.
Medical Officer Ingale Hospital, Pimpri, Pune.-3 months
Kotbagi Hospital, Aundh Pune..-3 months
Vishvashree Ayurvedic and- 6 months
Panchkarma center, Pune.
Clinical Research Coordinator - Dr.D.Y.Patil Medical Hospital-1 year 2 Months
Pimpri, Pune.

Experience in Clinical Research :
Trial Phase Duration
1 Hydroxychloroquine in type 2 Diabetes Phase 3 17/01.2011-29/02/2012
Double blinded trial
2 Primaquine in Malaria Phase 3 17/01/2011-29/02/2012
3 Comparative study of Losartan- Metoprolol vs Phase 3 17/01/2011-29/02/2012
Losartan- Ramipril in Essential Hypertension
with Type 2 Diabetes

Declaration : I hereby declare that, the information furnished above is true to the best of
my knowledge.
Dr. Rohinee R. Chothe.

[Guest]

Dear HR Manager
I am Neelesh Deshpande. I have come to know about the clinical Research professional job openings in your organization and I got the freedom to learn more about this field after completing my Post graduation diploma from focus educare Pvt.ltd.
I understand that working for your organization requires a candidate who is team oriented and is able to deal with people in various departments. I am confident that I possess these skills, which will help me to perform the job efficiently and effectively.
My goal is to transit my enthusiasm, creativity and experience into a position, where I continue to provide the strategic and tactical leadership critical to retaining valued customers of an organisation. I am certain that my presence in your team will prove to be beneficial to your organisation. As such, I would welcome an opportunity to speak with you to evaluate your needs and share my ideas.
I am a post graduate with in biochemistry with higher second class in my academics. In addition to that I have enclosed my resume with this cover letter that describes about my experience and educational background related to my field.
I would be thankful if I get a chance to prove my skills and interest in your organization. I hope to work with your organization as a dedicated employee. That's why I believe that whatever services I offer to you firm will be of great benefit to your firm.
Find my resume in the attachment for your overview. I hope for positive reply.
Sincerely,
Neelesh deshpande

[Guest]

Dear Sir/Madam,
Greetings!!!
I Ms.Preeti Baghel completed my B.Sc.Microbiology & Diploma of Clinical Research diploma
having work experience in clinical Research Field. I am keen interested in working with your esteemed organisation position of Clinical Research Associates for Pune location regarding opening,hereby I am sending you the my CV,so kindly go through the attachment & let me know .
Total Experience- 3 years ( Including CRC,Monitoring,Quality Assurance ,Site
Management,HR, Trial Association,BM & Project Management)
Current Position-currently I am working as a Project Manager at Axiom Lifesciences
Pvt.Ltd.pune.