Customer Service Clinical

MILONI PATEL

** **** *****,

Nashua, NH *****

Cell: 603-***-****

E MAIL: ************@*****.***

Objective

Dedicated, hard-working and reliable foreign medical doctor (BAMS -

Bachelor of Ayurveda, Medicine and Surgery) who maintains a focus on

accuracy and delivers courteous customer service at all times.

Seeking full time/part time Clinical research Associate or coordinator.

Strongly interested to conduct research with an ethical and safe manner.

I am looking to contribute my knowledge and experience of clinical

regulatory documentation and trial oversight to a professional organization

in need of assistance in successfully advancing through research studies,

meeting timely goals and providing care to patients.

Summary

. A Phase III, Double Blind, Randomized Study to Assess the Efficacy and

Safety of AZD9291 versus a Standard of Care Epidermal Growth Factor

Receptor Tyrosine Kinase Inhibitor as First-Line Treatment in Patients

with Epidermal Growth Factor Receptor Mutation Positive, Locally

Advanced or Metastatic Non-Small Cell Lung Cancer.

. A Double Blind Controlled Study of the Efficacy and Safety of

AGOMELATINE 25 or 50 mg and PAROXETINE 20 or 30 mg in Patient with

MAJOR DEPRESSIVE DISORDER.

. A Randomized Controlled Open Label Comparative study of RECOMBINANT

HUMAN GRANULOCYSIS STIMULATING FACTOR (rhg-csf) With NEUPOJEN in

Patient on MYCLOSUPPRESIVE Therapy for NON MYELOID MALIGNANCIES.

. A Double Blind Randomized Placebo Controlled Clinical Study in

Idiopathic Parkinson's Disease .Patient with "wearing off" Phenomenon

treated with levodopa plus a Dopa Decarboxylase inhibitor (DDCI)

. Monitor study activities to ensure compliance with protocols and with

all relevant local, federal and state regulatory and institutional

policies.

. Site management experience and the ability to work independently and

in a team environment

. Experience conducting site visits independently, including Start Up,

Close out, site management.

. Knowledge of FDA / ICH guidelines, GCP's and regulatory compliance is

necessary.

. Participate in the development of study protocols, including

guidelines of data collections procedures.

. Prepare study-related documentation such as case report forms,

instructional manuals, draft informed consents and progress reports.

. Qualify research study sites, including evaluating staff and facility

suitability for conduct of a clinical trial protocol.

. Initiate study sites; instruct research staff in scientific and

procedural aspects of studies including protocol-required procedures,

inclusion/exclusion criteria, visit windows, timing, adverse event

reporting, study data collection and documentation procedures.

. Provides and/or coordinates the delivery of a variety of patient

services under the direction of physician.

. Patient services are both clinical and non-clinical in nature and

include direct patient care activities such as taking vital signs,

performing phlebotomy and business functions such as data entry,

filing, assessing charges.

. Interacts with patients, physicians, and hospital personnel. Must

possess strong interpersonal and communication skills.

. Responsible for assisting and providing support to the members of the

clinical operations project team (i.e. Clinical Project Managers,

Associate Directors, or Directors), in order to facilitate the

management of pre- and post-approval clinical trial processes

including planning and execution of in-house or outsourced clinical

trials.

. Assists in the supporting the conduct of trials and may be responsible

for managing specific study and operational tasks.

Professional Profile

Employer : PAREXEL

Title : Clinical Monitor Associate I

Duration : 08/25/2014 to 12/12/2014

Roles and responsibilities:

. Build relationship with investigators and site staff remotely

. Act as PAREXEL's (CRO) remote contact with assigned clinical sites, use

judgment to assess and ensure overall integrity of study implementation

and adherence to study protocol at clinical sites. Prepare and collect

high quality site documents, such as essential regulatory documents (SRP)

. Compile SRP for review and approval

. Ensure adequate set-up of Trial Master File (TMF), file study documents

and standardize filing across all studies; perform TMF audits to ensure

compliance with applicable work instructions, SOPs and ICH GCP

guidelines. Routinely evaluate filing procedures to ensure adherence to

guidelines.

. Submit and follow up with site on CSA including budget, Anti-Bribery Law

(ABL) Survey (if not available), and site specific ICF

. Collaborate and involve Clinical Trial Specialists (CTS) on CSA

(including budget) and site specific ICF negotiations as required

. Collect site specific documents for IRB, EC, and RA as required

. Provide prepared EC package to PI for submission and follow up to secure

approval where required

. Have a good understanding of the various tasks related to study start-up,

initiation, ongoing monitoring, processing, and lock

. Edit/format Protocols and Reports; assist in design of CRF's and Informed

Consent.

. Support site with access to relevant study systems and ensure sites are

compliant with project specific training requirements.

. Responsible for assisting and providing support to the members of the

clinical operations project team (i.e. Clinical Project Managers,

Associate Directors, or Directors), in order to facilitate the management

of pre- and post-approval clinical trial processes including planning and

execution of in-house or outsourced clinical trials.

. Ascertain and recommend appropriate follow-up response to issues at

clinical sites including potential deficiencies in documentation,

communication, and the need for additional training

. Configure and distribute study documents to site with support of Research

Operations Assistant (ROA), including configuration of Investigator Site

Files

. Conduct general site contacts in accordance with the study specific

Monitoring Plan, which may include:

o Review recruitment plan and enrollment updates

o Follow-up on appropriate site related questions

o Address/resolve issues pending from the previous visit

o Address protocol questions with Functional Lead (FL) guidance if

required

o Check on site staff assignment

o Assess drug/study supply status

o Request outstanding documents

o Review site payment status

o Follow-up on data entry, query status, and SAEs

. Generate contact reports in accordance with departmental timelines

and/or sponsor timelines whichever is shorter

. Prepare sites and CRAs for on-site visits

. Conduct remote visits (qualification, initiation, monitoring, and

termination), if applicable.

. Collaborate with CTS and CRA on site issues/actions and provide

recommendations regarding site-specific actions and use judgment and

experience to assess the ability and motivation of site staff.

. Perform regular reviews of site level data in clinical systems (e.g.

CTMS, EDC, IVRS, and ISIS) and ensure timely and high quality data

entry compliance from sites.

. Re-train site staff on study specific tasks/procedures remotely as

required.

. Performs work within established protocols under general supervision.

Employer : CVS Pharmacy

Title : Pharmacy Technician

Duration : 04/02/2014 to 08/25/2014

Roles and responsibilities:

. Provide exceptional customer service to all patients and members of

the clinic staff

. Under direct supervision of a registered pharmacist, compounds and

dispenses medical prescriptions.

. Order, receive and store incoming pharmacy supplies.

. Direct the development of drug kit packaging and distribution systems.

. Verify medication stock and enter data in computer to maintain

inventory records.

. Perform various clerical duties relating to the department.

. Other duties as assigned.

Employer : Gurukrupa Hospital & Research Center

Title : Clinical Research Coordinator

Duration : 01/01/2006 to 11/30/2009

Role and Responsibilities:

. Ensured compliance with research protocol, clinical objectives, local

Institutional Review Board regulations, and FDA regulatory

requirements

. Ensuring the conduct of trials as per the ICH-GCP Guideline.

. Coordinate and collection of blood samples, cultures and other

specimen for laboratory analysis.

. Flawless experience in a completion of CRF & ECRF.

. Recruiting, scheduling visits and retention of patients, assisting for

study start up and site initiation.

. Compile and update the Site Master File, coordinating shipment of

samples and ensure timely receipt of lab reports.

. Maintain the study related logs-Screening, enrolment, drug

administration, correspondence logs.

. Coordinating in submission and approval ethics committee and answer

query from ethics committee.

. Site assessment, site initiation, monitoring, query resolution and

site closure by several CRO and companies.

. Interacting with principal investigator and other team members on

regular basis and discuss potential issues in compliance with study

requirement

. Sound knowledge of the broad aspects of fundamentals of clinical

research involving conduct, design and management of clinical trials

in accordance with the regulatory structure.

. Knowledge of ICH-GCP Guidelines, SCH -y and phases of Clinical trials.

. Supervise, plan and coordinate the clinical supplies activities within

the clinical trials research projects.

. Ensure that goals and objectives of projects are accomplished within

established time frames and budget guidelines.

. Ensure compliance with Good Manufacturing Practices and applicable

state and federal regulatory authorities.

. Participate in protocol review to identify clinical issues; establish

time frames; identify procedural and administrative issues; recommend

amendments to study protocols as appropriate.

. Manage clinical supply activities including labeling, packaging,

distribution of clinical trial supplies, randomization, development

and maintenance of clinical trial database and drug accountability

systems control.

. Provide oversight of domestic and international clinical supply

shipments.

Employer : Gurukrupa Hospital & Research Center

Title : Physician Assistant

Duration : 01/01/2006 to 11/30/2009

. Examining indoor and outdoor Patients, taking medical histories and

updating patient's files.

. Interpreted Lab, x-ray, EKG, and other diagnostic procedures

. Worked in various settings with a physician on site or off site

. Performing data entry task for insurance paperwork.

. Provide high Quality, passionate healthcare and sensitive to patient's

needs.

Employer : INDUS HOSPITAL & ICCU PVT. LTD

Title : Medical officer

Duration : 06/18/2007 to 11/01/2009

Clinical & administrative skills:

. Keeping record of patient's medical histories and vital signs as well

as in performing phlebotomy, urine analysis, injection and various

diagnostic procedure like Ascities fluid tapping and send blood

investigation to laboratory for routine, culture & sensitivity.

. Explaining treatment procedures, medication, diets according to

physician's instruction.

. Provided direct patient's care and administrative support like data

entry, medical record management, taking care of patient's billing and

medical office management.

. Able to work under pressure and deal with emergencies arrived together

in I.C.C.U.

Employer : Karnavati Hospital Pvt. Ltd.

Title : Medical Officer

Duration : From 03/10/2005 to 01/11/2006

Role and responsibility:

. Taking patient's medical histories and vital signs and facilitating

diagnostic examination.

. Conduct ancillary test e.g. Electrocardiogram, TMT, X RAY and

laboratory procedures.

. Reacted calmly and effective in emergency situation that immediately

put patients at ease.

. Preparing and administrating medications as directed by a physician.

EDUCATION QUALIFICATION

Graduation : B.A.M.S (Bachelor of Ayurvedic Medicine & Surgery)

Bachelor of Science in Medical Science

Institute : Akhandaanand Ayurvedic College.

University : Jamnagar, Gujarat, India.

Career Summary:

. Knowledge in panchkarma techniques and Ayurveda system of medicine and

it's

Preparation like kashayas, tailam, and churnas.

. Better understanding of yoga and meditation.

. Good knowledge of surgery related to piles and fissure.

Certification of award:

. A valid national PTCB Certified Pharmacy Technician Certification

. Training on "Introduction to the Clinical Drug Development Process;

ICH good clinical practice for Clinical Trial Sites" provided by

Quintiles Research Pvt Ltd.

. Participated as a delegate in the symposium of ayurvedic treatment on

acute heart disease held in 2nd February 2003 and certificate is

awarded by GUJARAT AYURVED RESEARCH & DEVELOPMENT CENTER.

. Participated in the symposium on vat vyadhi panchkarma chikitsa,

held on 3rd October 2004 and Ayurvedic " KSHARSUTRA" therapy held on

22nd Aug 2004, certifications are awarded by Akhil Bharatiy Ayurved

Mahasammelan.

EDUCATION SUMMARY

Name of Location From To Titles/Degree

institution (country/addres (Year) (Year)

s) awarded

Gujarat Jamnagar 1999 2003 Bachelor of

Ayurveda Gujarat Ayurvedic

University India Medicine &

Surgery(B.A.M.

S)

Gujarat Gandhinagar 1998 1999 Higher

Secondary Gujarat Secondary

Education India

Board

Gujarat Gandhinagar 1996 1997 Secondary

Secondary Gujarat

Education India

Board

Professional Strengths:

Knows medical terminology and symptomatology, Medication therapy,

Pharmaceutical knowledge about drug usage. Honest and dependable with

excellent interpersonal skills, team oriented, organized and manage time

well, possessing leadership skills, enthusiastic and hardworking, work well

under pressure, flexible and quick learner.

Technical Proficiencies:

Internet savvy, familiar with Microsoft word, Excel and Power Point and in

depth knowledge of basic operating system

References:

Raj Hassija

Software Engineering Director,

Velcro USA Inc.

MILONI PATEL

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