Email:firstname.lastname@example.org, Mobile No.: 408-***-****
*** *** *****, *** # ***, Sunnyvale, CA, 94086
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
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
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
> Evaluated and gave guidance to the project work done by the students
> Assessed examinations and provide constructive feedback to students.
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
As Physician Assistant and Clinical Research Coordinator Jan' 2004 -
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 &
> 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
> Organized meetings, teaching programs, workshops and patient education
sessions and assisting in preparation of databases and statistics of
> 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
> 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
> 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
> 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
EDUCATION AND TRAINING
> Certified in SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACRO, PROC/SQL and
> 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,
> 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.
> 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.
> 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.