Renjini Balakrishnan

Email:acdxv6@r.postjobfree.com, Mobile No.: 408-***-****

*** *** *****, *** # ***, Sunnyvale, CA, 94086

PROFESSIONAL SUMMARY

A highly skilled professional with over 9 years of experience in diverse

industries including Clinical research, healthcare, biomedical and

tutoring. Proficient in prioritizing and completing tasks in a timely

manner, yet flexible to multitask when necessary. Enjoys learning new

programs and processes. A team player who is attentive to detail and able

to work in a fast paced environment.

SKILLS AND EXPERTISE

Trained and experienced in ICH/GCP Coordinated Phase II,Phase IIb,Phase

Guidelines and FDA regulations III clinical trials

Good knowledge of 510K,GLP/GMP Medical procedures and terminology

Good organizational and multitasking Clinical Data Management

skills

Proficient in Microsoft Word, Excel, Conducted clinical trials in Urology

PowerPoint and Base SAS Oncology, Pediatric study group

Excellent communication skills Knowledge of MedDRA,CTMS and ARISg

Experience in EDC, EDT, HIS and EMR Medical practise

PROFESSIONAL EXPERIENCE

Lecturer

June 2012 to March 2013

Avigna Clinical Research Institute, Bangalore, India

Key Responsibilities as a lecturer

> Used to design teaching material and deliver teaching either across a

range of modules or within a subject area

> Actively involved in online content writing for the academic modules

> Ensured that content, methods of delivery and learning materials will

meet the defined learning objectives.

> Developed own teaching materials, methods and approaches with

guidance

> Evaluated and gave guidance to the project work done by the students

> Assessed examinations and provide constructive feedback to students.

Product Manager

March 2012 to May 2012

BIORAD MEDISYS PVT. LTD, Bangalore, India

Key Responsibilities as a Product Manager

> Provided training to the Production and Sales Personnel about the

various kinds of medical devices and their usage.

> Preparation of 510(K)& PMN for regulatory submission

> Suggestions for Product improvement, better quality and usage.

> Compared with other companies Products and co-ordinate with the

production team to make better product than competitor's products.

> Done a lot of market research and developed new products.

> Addressed and resolved various kinds of user complaints by providing

training to quality team

> Organized for various kinds of marketing materials like Catalogue,

Conference material and promotional materials.

Associate Team Lead

October 2010 to March 2011

Metropolis Healthcare Ltd. Mumbai, India

Key Responsibilities as an Associate Team Lead

> Preparation of TRF, LIM, SOP, other documents and protocol design

> Data Management

> Training to investigator regarding SOPs,

> Coordinate with multiple center

> Verification of CRC-DEO data entry and report

> Tracking the contract, Updating the kit inventory

> Track the financial of projects, study specific training for all team

> Revenue tracking and MIS reports

> Study specific training for team members and investigators in the

department regarding SOPs

> Overall supervision of clinical studies

> EDC and EDT services for many multicentric studies

From January 2003 to June 2010

Amrita Institute of Medical Sciences, Cochin, Kerala

Physician Assistant Trainee and Clinical Research Coordinator January

2003-January 2004

As Physician Assistant and Clinical Research Coordinator Jan' 2004 -

Jul'2008

As Senior Physician Assistant & CRC

July 2008 -June 2010

Key Responsibilities as a Physician Assistant

> Managed medical functions like history-taking, physical examination, done

routine & diagnostic investigations and given prescriptions after

consulting with concerned physician

> Assisted Physicians in outpatient clinic, conducted specialized test and

certain procedures, like Urodynamic, Uroflowmetry, Catheterization and

urethral dilatations, TRUS biopsies, flexible cystoscopy and stent

removal as well as Ultrasound examinations.

> Counselled patients and provided instructions on usage of drugs &

injections, etc.

> Rendered assistance to Physicians in ward rounds & provided help in

filling Physician Orders, Progress Notes, Consultation Forms, other

documents required for various examinations

> Given dietary advice to patients. Coordinated all the functions in

outpatient clinic.

> Organized meetings, teaching programs, workshops and patient education

sessions and assisting in preparation of databases and statistics of

diseases.

> Prepared discharge summaries and Medical Certificates.

> Worked in a variety of software applications like HIS (Hospital

Information system) EMR, ICD-9.

Key responsibilities as clinical research Coordinator in ICH GCP DRUG TRIALS

> Managed multiple clinical trials simultaneously. Responsible for all day-

to-day activities necessary to facilitate the successful completion of

each study.

> Developed and executed plan to ensure that all aspects of each study

were completed with strict adherence to the protocol, SOPs, guidelines

and ICH /GCP guidelines. Trained clinic personnel to effectively

complete study specific procedures and documentation.

> Evaluated and analyzed clinical research data to ensure accuracy and

consistency between source documents and study documents as well as

proper, timely reporting of critical study events.

> Collaborated with the PI to prepare IRB/IEC and any other regulatory

submission documents as required by the protocol.

> Established and organized study files, including but not limited to,

regulatory binders, study specific source documentation and other

materials.

> Coordinated participant tests and procedures. Collected data as

required by the protocol. Assured timely completion of Case Report

Forms. Maintained study timelines.

> Research experience in several therapeutic areas including Oncology,

Urology, pediatrics and medical devices

> Reviewed drug accountability, safety data and ensure that these are

recorded and tracked.

> Recorded data from patient charts, medical records, interviews,

questionnaires, diagnostic tests and other sources in accordance with

study plans.

> Analyzed data from different perspectives and summarizing it into useful

information and presenting the data in a useful format, such as a

graph or table.

> Data validation, edit checks and discrepancy management

> Maintained awareness of local regulatory requirements, and to conduct

studies in accordance with SOPs, guidelines and ICH Good Clinical

Practice guidelines.

EDUCATION AND TRAINING

> Certified in SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACRO, PROC/SQL and

Advanced Excel.

> Professional diploma in Clinical Research (PDCR)

> First class Master degree in Allied Health Sciences with 80% marks

(Second Rank), Amrita Institute of Medical Sciences, Cochin, Kerala,

2006.

> One and half years' Post Graduate Diploma in Allied Health Sciences with

82% marks, Amrita Institute of Medical Sciences, Cochin, Kerala,2003

> First class graduate in Zoology with 82.4% marks from Mahatma Gandhi

University, Kottayam, Kerala, 2001.

Computer skills:

> Skilled at using search engines.

> Certified in MS office.

CONFERENCES & WORKSHOPS ATTENDED

> 1st World Summit on Kidney Surgery - Tele video conference live from

Cleveland Clinic, Ohio & Nadiad; 2003.

> 37th Annual Conference of the Urological Society of India at Kochi; 2004

> Attended many CMEs and Research Methodology Workshops conducted in Amrita

Institute of Medical Sciences, Cochin, Kerala.

PUBLICATIONS

> Laparoscopic Adrenalectomy: a single centre experience with the lateral

transabdominal approach. Indian Journal of Urology 2006.

> Laparoscopic adrenalectomy is feasible for large adrenal masses [>6cm]

Asian Journal of Surgery, January 2007, Vol 30 No. 1; 52-56.

> Laparoscopic Adrenalectomy- is it any difference in Phaeochromocytoma and

non-phaeochromocytoma. Asian J Surg. 2007 Oct; 30(4): 244-9.

> Laparoscopic Adrenalectomy: experience with our initial 10 cases. Indian

journal of Urology 2004, Vol 20 (CS): 51.

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