www.clinigeneintl.com Clinigene International Ltd Bangalore : Clinical Research Associate

[Admin]

clinigeneintl.com

Our scientific innovations are driven by a highly skilled pool of professionals who we attract and train to become globally competitive. The opportunity to work in a stimulating environment together with inspired teams enables our people to deliver breakthrough performance.

Clinigene has, in a short span of time, earned a reputation for maintaining internationally benchmarked standards in clinical research. This distinction is the direct outcome of our highly qualified and motivated team of medical doctors, clinicians, pharmacologists, clinical research professionals, bioanalytical scientists, pathologists, biochemists, microbiologists and consultants.

Given the tremendous potential for growth in the field of clinical research and the emergence of Clinigene as a key player in clinical research, we are continuously looking for talented people with unique mix of experience and skill-sets.

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Clinigene International Limited
"Clinigene House",
Tower 1, Semicon Park
Electronic City, Phase II,
Hosur Road, Bangalore - 560100, India


Phone: + 91 80 2808 2780

Fax: + 91 80 2808 2737
Website: www.clinigeneintl.com

[Admin]

Clinigene International Ltd Bangalore Bangalore : Clinical Research Associate
Company Name : Clinigene International Ltd Bangalore
Company Location : Bangalore
Designation (of vacancy) : Clinical Research Associate
Company E-mail ID : careers@clinigeneintl.com
Company Website : www.biocon.com/clinigene.asp

Job Description, Candidate Profile, Company Profile, Company Address :

Job Description:
* Assist Project Manager with feasibility analysis and identification, and selection of investigators.
* Assist Project Manager in planning the conduct of the clinical trial and developing trial management systems.
* Assist in preparation of study budgets.
* Prepare documents for ethics committee and regulatory submissions.
* Assist in the planning and coordination of investigator meetings and prepare presentation materials and present information at these meetings.
* Assist in the management of recruitment strategies, when necessary.
* Assist in the management and preparation of tracking documents.
* Assist Project Manager with management of study drug/supply/equipment delivery, shipment, inventory, and accountability.
* Create documents required by the project team prior to the start of the study (e.g. protocols, feasibility questionnaires, patient tracking tools, etc.).
* Prepare, plan, organize and conduct pre-study (site selection) visits and report on these visits to Project Manager to assist in site selection.
* Prepare, plan, organize and conduct site initiation visits.
* Collect and review essential documents from study sites.
Candidate Profile:
The Senior CRA monitors projects under minimal supervision, supports the Project Manager and provides input to the feasibility, planning, investigator selection, budgeting, logistics, conduct and reporting of the study. The Senior CRA may be called on to serve as a mentor to junior CRAs and/or to undertake special projects or roles relating to project management.
Company Profile:
Established in the year 2000 as a Biocon subsidiary, Clinigene became India's first CAP (College of American Pathologists) accredited Central Laboratory. Clinigene's services now span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs.

Company Address :
Clinigene International Limited
"Clinigene House",
Tower 1, Semicon Park
Electronic City, Phase II,
Hosur Road, Bangalore - 560100, India

[Guest]

Vinamrata
E-Mail : vinamrata13 AT sify.com
OBJECTIVE :
To get aligned with a reputed firm or company to get deeper insight into the present education and utilize my knowledge and abilities in the industry that offers professional growth while being innovative and flexible.
TRAITS :
Enthusiastic, Self-Motivated & inquisitive to gain knowledge & achieve goals.
ACHIEVEMENTS :
University Topper in 3rd Semester
I
ACADEMIC QUALIFICATIONS :
Year and Course University\ Board Name of the Institution Aggregate
2008-2009,P.G Diploma in Advanced Clinical Research I
ICRIIII.
70
2004-2008,B.Tech in Industrial Biotechnology
Deemed
Bharath University, Chennai 9.1/10
2000 – 2001, Higher Secondary School
BIEC
B.N.College, Patna
68.70
1998-1999, S.S.L.C
ICSE St.Jospeh’s Convent High School, Patna
76

TRAINING AND CONFERENCES ATTENDED :
- International conference on “Recent advancements and challenges in biotechnology, 06, at BIHER deemed university, Chennai – 600073
- National Conference, 07, on “Recent trends and Facets in Biotechnology and Bioinformatics by Hindustan College of Arts and Science, Chennai – 10
- Undergone Training in Microbiological examination of portable water of various places in Patna for a period for 15 days in July 2006
- National Technical Symposium on Present & future perspectives in Bio- tech in Bharath University, March 2007
- Industrial Training in Distillery & Bio compost division of Mohan Breweries & Distilleries Ltd, Chennai for a period of 14 days , Sep. 2007
- Project work on ‘’Decolorization of Textile dyes by a thermostable laccase produced by white rot fungi(Pleurotus Sp.)in solid and submerged culture” at Gloris Biomed Research Centre,Chennai.
- Passed FDASmart Inc Programme “Understanding FDA and the FDA Approval Process” from Institute of Clinical Research(India) Delhi Campus
- A report on ‘’Importance of Referral in Recruiting Subjects for Clinical Trials’’ at ICRI,New Delhi
KEY SKILL :
COMPUTER PROFICIENCY
Computer Basics :Word,Power point,Excel
Networking :Internet,E-mails
JOB PROFILE :
Working as Asst. Clinical Research Co ordinator at RMRIMS(ICMR),Agamkuan ,Patna
Hobbies :
- Playing Instruments
- Travelling

[anooj chandran]

Curriculum Vitae for Clinical Research
Anooj M [MSc Microbiology + Diploma in Clinical Research.]
Email :anu123sat AT gmail.com, anooj.chandran AT cadilapharma.co.in
Total Experience (2.0 years)
- Worked as a Clinical Research Coordinator for Cadila Pharma in Bikner,Rajasthan .from May 2009 to May 2010
Presently employed with :
- Clinical Trial Division, Cadila Pharmaceuticals Ltd. as Clinical Research Associate, Clinical Operations, CADILA CRO (From June, 2010 to till date)
- Presently handling 3 trials -2 cancer trails and 1 non cancer trial, having sites all over India
- Conducted more than 30 monitoring
- Presently working on Clinical Study Report –of Bladder cancer Trial.
- Interested in Medical writing, Report preprations, Protocol writing etc
Reporting to Sr. Manager, Cadila CRO
Job Profile
I. Clinical Operations
- Ensuring compliance with the Protocol, International CRO’s SOPs and other applicable SOPs, ICH-GCP and other applicable regulatory requirements.
- Potential Site Identification, Selection & Feasibility for clinical trials
- Therapeutic area training of Clinical Trial monitors
- Regulatory support, clinical study material management, query resolutions, tracking and monitoring progress of projects
- Recruit investigators
- Interact with investigators to ensure a smooth study flow
- Negotiating budgets with the investigators
- Obtain, review, and process regulatory and administrative documents from investigator sites
- Site Initiation, Monitoring & Close out visits
- Manage and provide support to other team members in the conduct of the clinical trial
- Coordinate and present at Investigator Meetings
- Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
II. Medical Monitoring
- Collection and the review of Safety Data
- Review of Patient Eligibility for Enrollment in the trial
- The management of Safety Data as per regulations
- Reporting of patient safety data as expedited SAEs and Safety Reports
- Review of Adverse Events for Reporting
- Submission of Safety Reports to Regulatory bodies
III. Medical Writing
- Review and Preparation of IB, Protocols, CRF and Synopsis
- Preparation of Periodic News Letters for Clinical Trial Projects update letters
- Preparation of interim safety report
IV. Regulatory & Ethical Affairs :
- Co-ordinate with the regulatory authority.
- Update on the trial status such as change of investigators, site, SAE, site close-out/termination.
- Notifying SAE to regulatory agencies in expedited manner
V. Document Specialist :
- Clinical Trials & Project Management SOP new SOP drafting and revision
VI. Special Assignments :
- To understand the overall objectives of entire Clinical research department
- Assist the Sr. Manager in all clinical projects.
Career Objective
To work in a challenging atmosphere that provides ample opportunity for learning and growth and to carve a niche in whatever I undertake and to promote research activities with institution.
Educational Career
Examination Board/University Year Percentage/Grade
1 DCR Altree Lab Pvt Ltd 2009 Grade B
2 MSc Life Science Bharathiyar University 2007 60%
3 BSc Microbiology Karnataka University 2005 59%
Exposure of Clinical Trials
1) Ongoing
[1] BCG Refractory STCC of Bladder Trial (Phase I)
[2] Superficial Transitional Cell Carcinoma of Bladder Trial (Phase II)
[3] Sepsis Trial (Phase II)
2) Trail Handled as a Coordinator
[1] Non small Cell Carcinoma (Phase II)
[2] Hormone Refractory Prostate Cancer (Phase II)

Technical Skills
- Communication skills
- Fluency with English.Hindi,Malayalam,Tamil
- Proficient with MS office 2007, Internet tools & Basic Computer Application.
- Completed GCP Training (Certified Candidate).
- Excellent attention to detail and accuracy.
- Good research and communication skills.
- Can take responsibility for tasks and react to changing priorities.
- Have a good interpersonal skill and are able to work in a team or own if required.) Attn
Objective (Target Job)
Sr. Clinical Research Associate in Pharmaceutical/CRO set up.
Desired Job Type
Permanent full time Employment Status
Desired Location
Open to Global Positioning
Current CTC
2.7 Lacs per annum

[Guest]

Objective :
To secure a position whereby hard work, dedication and ability to acquire new skills will advantage any company I work for.
Current employer details
Company : - Manipal Centre For clinical research (Manipal University)
Address : - 7th floor, KMC Hospital, Attavar, Mangalore - 575001
Designation :-Clinical Research coordinator
Month/years of experience : - one year
Work experience
Department No : of trials Phase
Gastroenterology 1 3b/4
General Medicine 1 3
Oncology 1 3
Psychiatry 1 3
Previous employer details
Company : - Health and Research Centre
Address : - 1st Floor, Devi scans building, Kumarapuram, Medical College, Trivandrum
Designation :-Clinical Research coordinator
Month/years of experience : - 3 months
Work experience
Department No : of trials Phase
General medicine 2 3
Cardiology 1 3
Professional qualification :
- Completed 6 months Clinical Research Training from Altree lab, Cochin.
- Completed Post graduate Diploma in Clinical research from Annamalai University (Distance Education), Chidambaram.
- Completed Fellowship in Clinical research from Apollo Hospital, Hyderabad (online program).
Educational Qualification :
Degree/
course Discipline School/College Board/
University Year of
Passing
Fellowship in clinical research Clinical Research Apollo Hospital Medvarsity online limited 2010
PG Diploma in clinical research Clinical Research Annamalai University Annamalai University 2010
M.Sc. Microbiology Karpagam arts and science college, Coimbatore Bharathiar University 2009
B.Sc. Microbiology St.Mary’s college for women,Thiruvalla Mahatma Gandhi University 2007
H.S.C - Raja kesavadas N.S.S Higher secondary school,Trivandrum Board of higher secondary examination 2004
10th - Sree Vidyadhi Raja Vidya Mandir, Thiruvananthapuram. SSLC 2002
Responsibilities as a study coordinator
- Coordinating with PI in subject screening, Randomization, drug dispensing, IVRS/IWRS, drug accountability
- Subjects follow ups
- Source Documentation
- e CRF filling and query resolution
- Coordinating with CRA during site selection, monitoring visits and close out visits
- AE and SAE management
- Maintenance of Trial Master file(TMF)
- Ensure ethics committee receives safety notifications and other study related information as per regulatory requirements.
Workshops and Seminars attended
- State level conference and certification Program on Pharmacovigilance
IT Skills :
- EDC Software : Oracle, Inform, Medidata Rave, Data Track, Data labs
Papers presented
- Cellular effects of arsenic trioxide in cervical cancer.
Academic Projects
- Isolation & genetic variation in antibiotic producing in microorganisms.