Clinical Research Nurse

Academic Achievements

Sep **** – Feb **** Certified Clinical Research Programme

Altree Lab Pvt, Ltd, Ernakulam, Kerala(Clinical Research Organization)

**** ******** ** *******(B.Sc. Nursing)) Aggregate: 62%

Krupanidhi College of Nursing, Bangalore, Rajivgandhi University

2005 Plus- Two Aggregate: 60%

2003 S.S.L.C Aggregate: 75%

Projects

Feasibility assessment at the site, site evaluation, review of confidentiality agreement, SOP Review, feasibility questionnaire at the site, at the Altree Lab Pvt, Ltd, Ernakulam, Kerala in Jan 2010

Description:

A group project to understand the responsibilities of the CRO/Sponsor towards assessment of a clinical trial for feasibility was accomplished. Tasks such as reviewing Confidentiality Agreement, Clinical trial documents, SOP, designing a feasibility questionnaire and getting it filled by the investigator was done.

Pre- Screening of the Hypertensive patients for a Herbal study conducted by OUSHADI Pharmaceuticals, Thrissur, Kerala in Feb 2010.

Description:

The patients from different parts of Kerala has came those having Hypertensive disease(Already treated by some of the other Allopathic drugs), We just taking the Baseline data, lab tests, checking the inclusion and exclusion criteria’s

Professional Experience

1) Currently working as a Clinical Research Coordinator & Research Nurse at Regional Cancer Centre, Trivandrum, since November 2010.

Indication Phase Sponsor

Multiple myeloma

CNT0328MMY2001 Phase II Johnson & Johnson

Mantle Cell Lymphoma

LYM3002 Phase III Johnson & Johnson

Non-Hodgkin son Lymphoma

LYM3001 Phase III Johnson & Johnson

Soft Tissue Sarcoma

AP23572-07-302 Phase III Merck

Multiple myeloma (Refractory)

CNT0328MMY3001 Phase II Johnson & Johnson

2) I worked as Research Coordinator and Research Nurse for Cadila Pharmaceuticals From Mar 2010- Oct 2010, in Regional Cancer Centre & S.P Medical College Bikaner, Rajasthan. During that time I handled the trials as follows.

Indication Phase Sponsor

Superficial Transitional Cell Carcinoma Of Bladder (STCC) Phase II Cadila Pharmaceuticals

BCG Refractory in STCC Phase II Cadila Pharmaceuticals

Hormone Refractory Prostate Cancer (HRPC) Phase II Cadila Pharmaceuticals

Non Small Cell Lung Cancer (NSCLC) Phase II

Cadila Pharmaceuticals

3) I have done a certificate course in clinical research at Altree Lab (P) Ltd – Cochin. During This I worked as a clinical research nurse coordinator trainee from October 2009 to February 2010. During this time I handled Herbal trails of Hypertension.

Roles and Responsibilities as Research Coordinator

• Screen and maintain subject records

• Records collate and maintain trial data as per protocol

• Organizing specimen collection and delivering, investigation and reporting.

• Follow in patient trial progress during hospitalization, transfer and discharge.

• Liaise with chief investigator, Clinicians, other health professionals, other dept. and sponsors.

• Ensure Clinical Trials are conducted according to Protocols/Regulatory and ICH-GCP guidelines.

• Monitor accurate functioning of trial equipment

• Schedule subject visit as per protocol

• Arrange dispatch and shipment of samples

• Maintenance of Source notes, Investigators Site File and completing CRF’s

• Handling, Storage and Dispensing of the Investigational Product to subjects

• Provide update on subject recruitment and facilitate for monitoring

• Calling up IVRS for subject visits, discontinuation, Screen failure, drug receipt.

• Explaining the Informed Consent Document to the study subject

• Reporting SAE to EC and Sponsor

• Facilitate EC Submissions.

Roles and Responsibilities as a Nurse

• Patient Care

• Keep a good rapport with the patient

• Taking Samples from the patient

• Checking vital signs

• IP administration (Injections, Infusions, Tablets, Inhalations…)

• Provide health counseling and education and also make necessary referrals

• Responsibilities for the conduction of the health screening

• Keep the track records of the patient for student’s update and general information

• In-depth knowledge of the advanced technologies and equipments with the perfect knowledge of the medical terminology

• Great demonstration and leadership qualities

• Very careful and responsible towards health care

• Energetic and positive attitude with the profound communication skills both verbally and written.

• Accurately dispensed medicine

• Analyzed laboratory results

• Facilitated pain management

• Performed sterile procedures

• Effectively interpreted patient’s data

• Collaborated with professional team

• Strong ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations.

• Remarkable ability to write reports, business correspondence, and procedure manuals.

• Sound ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

• Solid ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.

• Uncommon ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

• Remarkable ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Immense ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

• In-depth ability to interact with persons from varied socioeconomic and ethnic backgrounds.

• Considerable skill in nursing techniques; skill in the supervision and training the LPNs and Nurse Aides.

• Great knowledge professional nursing principles and techniques; medical terminology; hospital routine and equipment; and medicines and narcotics.

• Excellent ability to apply nursing techniques; observe and record symptoms and behavior; keep records and prepare reports; gain the interest, respect and cooperation of clients; and plan and organize.

• Bilingual in English/Spanish.

• Strong ability to relate appropriately to, communicate effectively with, and develop trust in relationships with diverse patient population and with staff.

• Proven ability to meet and exceed the Service Excellence Standards of TVHC, Inc.

• Profound ability and willingness to work on an as-needed basis in order to meet operational needs of the clinic.

• Assisted in BMT(Bone Marrow Transplantation)

Summary of Nursing Qualifications

• Advocate for patients rights; strive to understand a patient’s needs and concerns.

• Hardworking and energetic; flexible; adapt easily to change of environment and work schedule.

• Maintain critical thinking skills essential to providing competent and dignified patient care.

• Personable with a positive attitude; interface well with patients, families, and nursing staff.

• Team leader with able to create a positive working environment that uplifts patients’ spirits.

Summary of Clinical Research Qualifications

• Tremendous research aptitude with vast theoretical knowledge

• Extraordinary ability to maintain quality performance for long working hours

• Good exposure to practical techniques through extensive work experience

• Excellent computer proficiency and expertise in searching information through web

• Good communication and comprehension skills

• Quality documentation and accounting skills

Extensive Knowledge in

CRF filling.

Performing IP management

Assisting IEC correspondence

Assisting ICF process

Performing Patient counseling for study compliance.

Assisting in patient recruitment & education.

Patient interaction

Vital signs checking

Drug Dispensing

Drug administration

GUIDELINES

ICH-GCP Guidelines.

Regulatory Guidelines (Schedule Y, US-FDA).

ICMR Guidelines/Indian GCP.

Clinical Trial Designs.

e-CRF Handled

• Phase Forward Inform Version 4.6

• Medidata Rave

• Oracle Clinical Remote Data Capture (OC-RDC)

Seminars

• Attended Workshop on Innovative Approaches in Mother & Childcare conducted at Krupanidhi college of nursing, Bangalore on 08 Oct to 10 Oct 2009.

•

• Attended third ACRP chapter meeting on challenges in improving quality in

clinical research – An Indian perspective held at API Bhavan on 13 December 2008,

Bangalore.

• Attended CRC Training conducted by Cadila Pharmaceuticals on 9th and 10th April 2009 at Bikaner, Rajasthan.

• Presented Seminars on “ Investigators ICH-GCP” at Altree Lab Pvt , Ltd, Ernakulam, Kerala.

• Presented Seminars on “ Principals of ICH-GCP” at Altree Lab Pvt, Ltd, Ernakulam, Kerala.

• Completed online GCP training programmes.

Computer Skills:

Proficient in MS office tools such as MS Word, Excel and PowerPoint and proficient in the Internet

PERSONAL DETAILS:

Father’s Name Varghese Palatty

Mother’s Name Jainamma K.A

Date Of Birth 30-05-1988

Nationality, Marital Status Indian, Unmarried.

Residential Address Palatty (H), Puthenvelikkara (P.O), Ernakulam (Dist), Kerala-683594.

Passport No & Expiry Date H6481563, 15- Mar 2020

Languages Known English, Hindi, Kannada, Malayalam and Tamil.

Strengths Excellent organizational skill, Eye for detail, Optimistic, Patience.

Hobbies Listening to Music, Traveling, Watching Television

References:

Dr Sreejith Nair, Associate professor, Medical oncology, Regional cancer Centere, Trivandrum, Kerala. Ph- +919*********.

Mr.Pushparaj Singh, Senior Clinical Research Associate, Cadila

Pharmaceuticals, Ahamadabadh, Ph-+919*********.

Mr. Anooj Chandran, Clinical Research Associate, Cadila Pharmaceuticals,

Ahamadabadh, Ph-+919*********

DECLARATION

I do hereby declare that the above mentioned particulars are true to the best of my knowledge and belief.

Place- Ernakulam, Kerala SEJO VARGHESE

Date-03-06-2011

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